Long term outcomes of drug-coated balloons versus drug-eluting stents in patients with small vessel coronary artery disease | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Long term outcomes of drug-coated balloons versus drug-eluting stents in patients with small vessel coronary artery disease Hesham Refaat, Mohamed Arab This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4659117/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Drug-eluting stents (DES) are a normative care of coronary stenosis. However, their efficacy was limited by stent thrombosis and in-stent restenosis especially in small vessel coronary artery disease (SvCAD). The aim of this study was to assess angiographic efficacy and clinical outcomes of drug coated balloons (DCB) as compared with DES in SvCAD setting. Methods A total of 100 SvCAD patients with percutaeous angioplasty of culprit coronary arteries 70% stenosis were enrolled in this study. The patients were categorized into DES arm and DCB arm. One year clinical outcomes were assessed. The primary endpoint was in-lesion late lumen loss (LLL). The secondary endpoints were vessel thrombosis, major bleeding, all-cause death and major adverse cardiac events (MACEs). Results One year clinical follow-up revealed that in-lesion LLL was significantly lower in DCB arm as compared with DES arm (P = 0.004). Composite MACE was significantly higher in DES group compared to DCB group (P < 0.001). Non-fatal myocardial infarction (MI), target lesion revascularization (TLR), and major bleeding in DES group were significantly higher than DCB group (P = 0.04 & P < 0.001 & P = 0.03, respectively). However, there was a numerically; but not significantly, higher incidence of cardiac death (P = 0.65), and vessel thrombosis (P = 0.18) in DES arm compared to DES arm. Conclusion In SvCAD setting, DCB has favourable angiographic and clinical outcomes; as evidenced by lower LLL and composite MACE at one year follow up, compared to DES. Drug coated balloon Drug eluting stent Small coronary vessels Figures Figure 1 Introduction The overall percutaneous interventions for coronary artery disease (CAD) have a dramatic progress over the last few decades. Drug-eluting stents (DES) were normative care of coronary stenosis described in 2002 and then experienced a great technical improvement leading to reduced rates of in-stent restenosis (ISR) in relation to bare metal stents (BMS) [1]. However, despite improving clinical outcomes with the latest generation DES, their efficacy was limited by both stent thrombosis (ST) and ISR especially when deployed in small vessel coronary artery disease (SvCAD) [2]. The incidence of late ST could be attributed to inflammation, delayed healing and endothelial dysfunction. Thus, DESs did not remove the risk of ISR, but only reduced it necessitating a longer duration of dual antiplatelet therapy [3]. In particular, the SvCAD could be considered as a significant risk factor for adverse outcomes following percutaneous coronary intervention (PCI). In recent studies, SvCVD has been defined as an angiographic reference vessel diameter of less than 3 mm [4]. It is often diffuse and multi-vessel on presentation and is associated with this higher risk of ISR and ST conferring worse outcomes, higher rates of major adverse cardiac events (MACE) and target lesion failure after PCI [5]. Subsequently, the possibility to treat SvCAD without implanting a permanent prosthesis by means of direct delivery of an anti-proliferative drug through drug-coated balloons (DCB) has been considered appealing since the initial results of this strategy were published ten years ago [6]. Of note, the best practice guidelines on the management of SvCAD interventions remain limited. The DCBs are a novel and evolving technology leading to revascularization without leaving a foreign body and provides an attractive alternative in treating SvCAD. They are designed as semi-compliant balloon catheters coated in lipophilic anti-proliferative drugs and deliver the anti-proliferative drugs into vascular wall without implanting stents. Thus, DCBs have emerged as a viable alternative for some specific clinical settings; including high bleeding risk, ISR and de novo coronary lesions particularly in SvCAD [7]. Clinical data on the application of DCBs in treating CAD; particularly acute coronary syndrome (ACS), are scarce with nonrandomized clinical studies revealing the feasibility and safety of this approach [8]. The DCBs are currently recommended in the European Society of Cardiology guidelines as class IA for treating ISR [9]. However, the application of DCB for patients with SvCAD remains controversial because different studies have obtained conflicting conclusions. Moreover, despite the widespread use of DCB, their post-marketing analysis has been limited to one year follow-up, and adequately powered randomized clinical studies including long-term follow-up to study clinical outcomes with DCB versus DES treatment in SvCAD are not available [10]. The aim of this study was to assess the angiographic efficacy and long term clinical outcomes of this DCB as compared with DES in patients with SvCAD. Methods Study population Between March 2023 and April 2024, a total of 132 CAD patients who were hospitalized for chronic coronary syndrome (CCS) or ACS and underwent PCI; either by DES or DCB, of de novo culprit lesions in native coronary arteries at our Institution were enrolled in this study. The inclusion angiographic characteristics were SvCAD with less than 3 mm diameter and more than 70% stenosis based on visual estimation. Other inclusion criteria were complete reporting of angiographic and clinical outcomes during one year follow up such as late lumen loss (LLL), vessel thrombosis, major bleeding, all-cause death and MACE including non-fatal myocardial infarction (MI), cardiac death, target vessel revascularization (TVR), target lesion revascularization (TLR). Concomitant PCI of coronary lesions more than 3 mm in diameter or ISR in the same epicardial coronary artery, inability to provide informed consent, loss of systematic follow-up, life expectancy less than 2 months, and pregnancy led to exclusion of 32 patients from this study. Thus, 100 patients were finally included in our study. The patients were categorized into two main groups; those with PCI to SvCAD using DES and others treated with DCB. The study was carried out in adherence to the principles of the Declaration of Helsinki on Biomedical Research Involving Human Subjects. The institutional Ethics Committee approved the study protocol. All study participants gave written informed consent before the procedure. Clinical data collection Baseline demographics and clinical characteristics of enrolled patients were obtained from our hospital records. Cardiovascular risk factors of these patients were identified. The diagnostic criteria of diabetes mellitus (DM) were confirmed in those patients already receiving active treatment or having fasting glucose ≥ 126 mg/dL or glycated haemoglobin (HbA1C) ≥ 6.5% or impaired oral glucose tolerance test (OGTT) with 2h glucose ≥ 200 mg/dL. Hypertensive patients were defined as those taking antihypertensive therapy or those with systolic blood pressure (SBP) > 140 mmHg and/or a diastolic blood pressure (DBP) > 90 mmHg. Dyslipidemia was diagnosed with a total cholesterol level > 200 mg/dL or low-density lipoprotein cholesterol (LDL-C) > 100 mg/dL, or when the patients were already on lipid-lowering therapy according to Adult Treatment Panel III Guidelines [11]. Family history of premature CAD was defined as the presence of CAD in the first-degree relatives before 55 years old for men and 65 years old for women. Patients using tobacco products and those with smoking cessation within one month could be considered smokers [12]. Blood samples and laboratory analysis Venous blood samples were withdrawn from all patients on admission prior to coronary angiography. The following laboratory parameters were obtained: complete blood count, lipid profile, creatinine level, and estimated glomerular filtration rate (eGFR) [13]. Electrocardiogram (ECG) analysis and echocardiography protocol A resting ECG was obtained from all patients on admission. Comprehensive echocardiographic examinations were performed before coronary angiography by well-trained echocardiographers according to the standard recommendations of the American Society of Echocardiography [14]. Coronary angiography protocol Coronary angiography was done at our catheterization laboratory via radial or femoral access using 6 or 7 Fr sheaths and catheters with administrating 0.2 mg of intracoronary nitroglycerin. Multiple projections were used for adequate analysis of target lesions characteristics by two experienced blinded interventional cardiologists. PCI protocol All patients were treated according to standardized PCI guidelines including the peri-procedural and subsequent antithrombotic regimen [15]. Angiographic success was defined as final stenosis < 30% in the DCB arm and < 20% in the DES arm, without major, flow-limiting dissections and Thrombolysis In Myocardial Infarction flow grade 3 (TIMI 3). Procedural success was defined as angiographic success and the absence of in-hospital cardiovascular complications. In case of PCI with DES, lesion preparation with balloon pre-dilatation, post-dilatation to ensure optimal angiographic results and using glycoprotein IIb/IIIa (GP IIb/IIIa) receptor antagonists were selectively used according to the operator’s judgment. In case of PCI with DCB, lesion preparation was mandatory before DCB inflation. The DCB should be 2 to 3 mm longer on each side than the pre-dilatation balloon to avoid geographic mismatch. The DCB should be inflated at its nominal inflation pressure for at least 30 seconds. If this resulted in major flow limiting dissection or residual stenosis > 30% after its use, stenting with DES could be considered After PCI, a dual antiplatelet therapy (DAPT) was prescribed using acetylsalicylic acid (100 mg/d) and either clopidogrel (75 mg/d) or ticagrelor (90 mg twice per day). DAPT was continued for 4 weeks after DCB or 6 months after DES in CCS and for 12 months in ACS. In case of a combination of DCB and DES, DAPT was recommended for 6 months. In patients with oral anticoagulation, current guidelines were followed irrespective of DCB or DES treatment [16]. All patients were discharged with a scheduled angiographic assessment and regular clinical visits during one year follow up. Angiographic analysis and follow up Baseline and follow-up coronary angiographies were assessed in an independent core lab. Two orthogonal angiographic views were performed during admission, after PCI, and during one year follow-up maintaining similar angulations. Additional views could be required for the precise localization of DCB and DES. Quantitative coronary artery analysis (QCA) was performed for better angiographic analysis. Clinical outcomes Angiographic and clinical outcomes were assessed during one year follow-up with structured clinical questionnaires or phone calls to assess clinical outcomes and medication. The primary endpoint of this study was in-lesion LLL. The secondary endpoints included vessel thrombosis, major bleeding all-cause death and MACEs defined as the composite of cardiac death, non-fatal MI, TLR and TVR. Cardiac death was defined as any death not related extra-cardiac origin. Myocardial infarction was defined according to the recent guidelines [17]. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding [18]. Vessel thrombosis included in-stent thrombosis (IST), ISR, and vascular occlusion. An independent and blinded clinical events committee adjudicated all end points. Statistical analysis Data distribution was first assessed using the Kolgormonov-Smirnov test. Then, categorical data were compared based on the chi-square test or Fisher exact test. Continuous variables were also compared according to an unpaired Student’s t-test or Mann–Whitney U-test. Data were expressed as mean ± standard deviation. Two-sided statistical tests were achieved with p-value of ˂0.05 representing a statistically significant difference. All these analyses were done using SPSS version 20 (SPSS Inc, Armonk, NY, USA). Results A total of 100 CAD patients underwent coronary angiography at our institution with an evidence of SvCAD was enrolled in this study. Subsequently, out of these 100 patients, 50 patients were treated with DCB and the other 50 patients did PCI with DES. Demographical characteristics: Baseline demographic characteristics are shown in Table 1 . This study population included 63 males (63%) with no significant difference noted between DES and DCB groups (P = 0.3). Similarly, no differences were significantly noted between these two groups regarding the mean age of patients (P = 0.96). However, family history of CADs was more noted in 48% of patients who did PCI with DES, compared to only 24% of patients treated with DCB (P = 0.01). There were no significant differences between two groups regarding other cardiovascular risk factors. Table 1 Baseline characteristics of the studied groups. All patients (n = 100) DCB (n = 50) DES (n = 50) P-value Demographic characteristics Male sex, n (%) 63 (63%) 29 (58%) 34 (68%) 0.3 Age, years 59.67 ± 9.84 59.62 ± 10.11 59.72 ± 9.66 0.96 Cardiovascular risk factors, n (%) Diabetes Mellitus 51 (51%) 22 (44%) 29 (58%) 0.16 Hypertension 66 (66%) 34 (68%) 32 (64%) 0.67 Family history of CADs 36 (36%) 12 (24%) 24 (48%) 0.01 Current smoking 56 (56%) 25 (50%) 31 (62%) 0.23 Dyslipidemia 59 (59%) 33 (66%) 26 (52%) 0.16 CKD 28 (28%) 13 (26%) 15 (30%) 0.66 Clinical characteristics Clinical presentation, n (%) ACS 71 (71%) 39 (78%) 32 (64%) 0.12 CCS 29 (29%) 11 (22%) 18 (36%) Blood pressure, mmHg SBP 141.6 ± 19.27 138.7 ± 19.79 144.5 ± 18.47 0.13 DBP 83.34 ± 11.79 82.58 ± 12.06 84.1 ± 11.59 0.52 Heart rate, b/m 78.52 ± 11.74 78.46 ± 11.95 78.58 ± 11.65 0.96 TTE parameters LVEDD, mm 57.94 ± 7.79 57.84 ± 8.04 58.04 ± 7.62 0.89 LVESD, mm 36.88 ± 6.62 37.2 ± 6.81 36.56 ± 6.47 0.63 LVEF, % 51.68 ± 11.17 51.28 ± 11.48 52.08 ± 10.96 0.72 KILLIP class, n (%) class I 77 (77%) 41 (82%) 36 (72%) 0.44 class II 19 (19%) 7 (14%) 12 (24%) class III 4 (4%) 2 (4%) 2 (4%) Laboratory characteristics Hemoglobin, gm/dl 11.2 ± 1.79 11.28 ± 1.87 11.12 ± 1.72 0.66 Leukocytes, x10 3 /µL 8.21 ± 3.29 8.39 ± 3.36 8.02 ± 3.24 0.58 Platelets, x10 3 /µL 296.17 ± 98.62 297.46 ± 99.77 294.88 ± 98.44 0.89 TGs, mmol/L 3.1 ± 2.29 2.36 ± 1.09 3.84 ± 2.88 0.001 TC, mmol/L 5.91 ± 1.21 5.93 ± 1.2 5.88 ± 1.24 0.83 LDL-C, mmol/L 3.46 ± 1.01 3.27 ± 1.02 3.65 ± 0.98 0.06 HDL-C, mmol/L 1.1 ± 0.33 1.1 ± 0.35 1.1 ± 0.31 0.98 Creatinine, mmol/L 95.77 ± 33.86 95.36 ± 33.79 96.18 ± 34.27 0.9 eGFR, ml/min/1.73 m 2 50.92 ± 13.88 52.76 ± 14.02 49.08 ± 13.64 0.19 Abbreviations: ACS, acute coronary syndrome; CADs, coronary artery diseases; CCS, chronic coronary syndrome; CKD, chronic kidney disease; DBP, diastolic blood pressure; DCB, drug coated balloon; DES, drug eluting stent; eGFR, estimated glomerular filtration rate; HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol; LVEDD, left ventricular end diastolic dimension; LVEF, Left ventricular ejection fraction; LVESD, left ventricular end systolic dimension; SBP, systolic blood pressure; TC, total cholesterol; TGs, triglycerides; TTE, trans-thoracic echocardiogram. Clinical and laboratory characteristics: Clinical and laboratory characteristics are shown in Table 1 .There was no significant difference regarding the clinical presentation of enrolled patients where ACS was documented in 78% of patients treated with DCB, and 64% of those with PCI using DES (P = 0.12). Moreover, there were no significant differences between DCB and DES groups regarding other clinical characteristics. Similarly, there were no significant differences regarding laboratory characteristics apart from significantly elevated triglycerides (TGs) in DES group compared to DCB group (3.84 ± 2.88 vs. 2.36 ± 1.09 mmol/L, P = 0.001). Lesion and procedural characteristics: Lesion and procedural characteristics are shown in Table 2 . Multi-vessel disease was noted in 31% of all included patients with no significant differences between those treated with DCB and others enrolled in DES group (P = 0.52). Similarly, reference vessel diameter (RVD), pre-PCI minimal lumen diameter (MLD) and pre-PCI diameter stenosis were not statistically significant between those two groups (P = 0.95, P = 0.09, and P = 0.17, respectively). Table 2 Lesion and procedural characteristics of the studied groups. All patients (n = 100) DCB (n = 50) DES (n = 50) P-value Lesion characteristics Multi-vessel disease , n (%) 31 (31%) 14 (28%) 17 (34%) 0.52 Target vessel, n (%) 0.07 LAD 35 (35%) 20 (40%) 15 (30%) LCX 39 (39%) 14 (28%) 25 (50%) RCA 26 (26%) 16 (32%) 10 (20%) Lesion length, mm 23.97 ± 4.87 28.78 ± 5.53 27.3 ± 5.33 0.02 RVD, mm 2.31 ± 0.28 2.31 ± 0.29 2.31 ± 0.28 0.95 Pre-PCI MLD, mm 0.89 ± 0.33 0.95 ± 0.34 0.84 ± 0.3 0.09 Pre-PCI diameter stenosis, % 86.75 ± 6.9 85.8 ± 7.03 87.7 ± 6.72 0.17 Procedural characteristics Post-PCI MLD, mm 2.31 ± 0.27 2.3 ± 0.26 2.32 ± 0.28 0.78 Post-PCI diameter stenosis, % 13.0 ± 12.14 13.5 ± 13.82 12.5 ± 10.31 0.68 Acute gain, mm 1.41 ± 0.34 1.35 ± 0.32 1.48 ± 0.34 0.06 Procedure time, minutes 24.74 ± 6.49 23.98 ± 6.75 25.5 ± 6.18 0.24 Fluoroscopy time, minutes 16.42 ± 5.89 17.04 ± 5.93 15.8 ± 5.86 0.29 Amount of contrast, ml. 157.85 ± 46.27 161.9 ± 46.12 153.8 ± 46.52 0.38 Device length, mm 28.04 ± 5.46 28.78 ± 5.53 27.3 ± 5.33 0.18 Device size, mm 2.41 ± 0.27 2.31 ± 0.28 2.51 ± 0.22 < 0.001 Inflation pressure, atm 9.38 ± 2.76 6.78 ± 0.58 11.98 ± 1.13 < 0.001 Inflation duration, seconds 57.19 ± 37.91 91.7 ± 21.11 22.68 ± 5.32 < 0.001 Abbreviations: DCB, drug coated balloon; DES, drug eluting stent; LAD, left anterior descending coronary artery; LCX, left circumflex coronary artery; MLD, minimal lumen diameter; PCI, percutaneous coronary intervention; RCA, right coronary artery; RVD, reference vessel diameter. The left anterior descending coronary artery (LAD) (40% vs. 30%) and right coronary artery (RCA) (32% vs. 20%) were more frequent target vessels in patients treated with DCB, compared to those included in DES, but without statistical significant difference (P = 0.07). On the other hand, left circumflex coronary artery (LCX) was the main target vessel in DES group (50% vs. 28%), and similarly without significant differences (P = 0.07). Of note, the lesion length was significantly more in DCB group compared to DES group (28.78 ± 5.53 vs. 27.3 ± 5.33 mm, P = 0.02). Regarding procedural characteristics, DES size were significantly more than DCB size (2.51 ± 0.22 vs. 2.31 ± 0.28 mm, P < 0.001). By contrast, DES was not significantly longer than DCB (27.3 ± 5.33 vs. 28.78 ± 5.53 mm, P = 0.18). Moreover, inflation pressure required for DES deployment was significantly higher than that required for DCB inflation (11.98 ± 1.13 vs. 6.78 ± 0.58 atm, P < 0.001). On the other hand, prolonged inflation was more significantly noted in DCB group compared to DES group (91.7 ± 21.11 vs. 22.68 ± 5.32 seconds, P < 0.001). There were no statistical significant differences regarding other procedural characteristics, specifically acute gain (P = 0.06), procedure time (P = 0.24), fluoroscopy time (P = 0.29), and amount of contrast (P = 0.38). Clinical outcomes at one year follow up: Table 3 describes clinical outcomes at one year follow up. In-lesion LLL; the primary study endpoint, was significantly lower in DCB arm as compared with DES arm (0.06 ± 0.12 vs. 0.14 ± 0.17 mm, P = 0.004). Concurrently, one year clinical follow-up revealed that the composite MACE occurred in 31% of all enrolled patients, with a significant higher incidence in DES group in comparison to DCB group (50% vs. 12%, P < 0.001). Table 3 Outcomes at one year follow up of the studied groups. All patients (n = 100) DCB (n = 50) DES (n = 50) P-value Primary endpoints In-lesion late lumen loss, mm 0.09 ± 0.15 0.06 ± 0.12 0.14 ± 0.17 0.004 Secondary endpoints Composite MACE, n (%) 31 (31%) 6 (12%) 25 (50%) < 0.001 Cardiac death, n (%) 5 (5%) 2 (4%) 3 (6%) 0.65 Non-fatal MI, n (%) 10 (10%) 2 (4%) 8 (16%) 0.04 TVR, n (%) 2 (2%) 1 (2%) 1 (2%) 1.0 TLR, n (%) 23 (23%) 4 (8%) 19 (38%) < 0.001 Major bleeding, n (%) 8 (8%) 1 (2%) 7 (14%) 0.03 Vessel thrombosis, n (%) 10 (10%) 3 (6%) 7 (14%) 0.18 Abbreviations: DCB, drug coated balloon; DES, drug eluting stent; MACE, major adverse cardiac event(s); MI, myocardial infarction; TLR, target lesion revascularization; TVR, target vessel revascularization. Specifically, the risk of non-fatal MI, TLR, and major bleeding in DES group was significantly higher than DCB group (16% vs. 4%, P = 0.04 & 38% vs. 8%, P < 0.001 & 14% vs. 2%, P = 0.03, respectively). However, there was a numerically; but not significantly, higher incidence of cardiac death (6% vs. 4%, P = 0.65), and vessel thrombosis (14% vs. 6%, P = 0.18) in patients treated with DES, compared to those with PCI using DES. Of note, TVR incidence was similar (2%) in both groups. The primary and secondary endpoints in DCB and DES groups are presented in Fig. 1 . Discussion Three major findings arise from this study. (1) DCB has a comparable performance to DES in patients with SvCAD, in terms of procedural characteristics, where there are no significant differences between DCB and DES regarding acute gain, procedure time, fluoroscopy time and contrast volume. (2) Regarding angiographic outcomes within one year after SvCAD revascularization, in lesion LLL is significantly lower in patients treated with DCB, compared to those with PCI using DES. (3) Regarding long term clinical outcomes within one year, composite MACE, non-fatal MI, TLR, and major bleeding are more frequent in patients with PCI using DES. However, DCB doesn`t outperform DES in terms of cardiac death, TVR, and vessel thrombosis. It is well known that PCI with DES has been widely used for CAD patients. PCI aims to improve the minimum lumen diameter in a culprit coronary segment [19] with subsequent increase immediately after the procedure but decreases at follow-up. This could be mainly attributed to recoil and hyperplasia phenomena. The amount of this neointimal hyperplasia is mainly independent of the vessel size and SvCAD is more prone to re-stenosis than larger coronary vessels [20]. In the SvCAD setting, the prospective Spirit SV study reported TLR rate of 10.8% after 13 months with Xience DES [21]. The cumulative data analysis of the SPIRIT and COMPARE studies shows a 2-fold risk of MACE versus larger vessels [22], with a significantly higher risk of MI and TLR. The TWENTE II study showed similar data, with a TLR rate of 9.5% versus 5.4% in larger vessels after two years, and a significantly higher risk of MI and TLR in the SvCAD setting [5]. Given these limitations of DES in terms of ISR and ST, DCB angioplasty has been shown to be a new revascularization modality for the treatment of SvCAD. To date, only few RCTs compared DCB angioplasty with DES in SvCAD, and thus the aim of this study was to assess the angiographic efficacy and long term clinical outcomes of DCB in treating patients with SvCAD as compared with DES. The first DCB generation failed to prove the angiographic non-inferiority versus DES in the prematurely interrupted PICCOLETO trial that was the first RCT to compare DIOR paclitaxel-DCB and Taxus Liberte´ paclitaxel-DES in SvCAD [23]. This trial was terminated early due to a higher rate of TLR and MACE after six months. It was hypothesized that these findings could be attributed to lack of efficacy of the used DIOR paclitaxel-DCB that was later replaced by newer generation DCBs [24]. Similarly, SCAAR registry in Sweden between 2009 and 2017 supported this finding and reported an increased restenosis risk in patients undergoing PCI on SvCAD with DCB compared with DES, while there was no difference in all-cause deaths or vessel thrombosis [25]. By contrast, newer-generation DCB showed the potential advantages of using this modality in treating SvCAD. Regarding angiographic outcomes, the BELLO study documented the angiographic superiority of paclitaxel-DCB (IN.PACT Falcon) versus paclitaxel-DES (Taxus Liberte) in SvCAD patients during three year follow up [26]. Also, RESTORE SVD study showed that the Restore DCB was not inferior to a new generation DES regarding diameter stenosis with also no significant differences regarding LLL during one year follow up. This dramatic benefit of this newer DCB generation could be related to balloon pre-dilatation [27]. Concurrently, the present study revealed a favourable long term angiographic outcomes resulting from DCB, compared to DES in SvCAD patients. During one year follow up, the in-lesion LLL was significantly lower in patients treated with DCB in comparison to those with PCI using DES (P < 0.001). This could be explained by the fact that DCB delivers anti-proliferative drugs into vascular wall without implanting a stent mediating a suppression role on intimal hyperplasia and inflammation. Moreover, the use of DCB may theoretically overcome the risk of negative vascular remodelling obtained with plain balloon angioplasty, and both the immediate encumbrance and the subsequent neointimal proliferation after stent implantation may be reduced [28]. The PICCOLETO II study also confirmed this angiographic superiority evidenced by LLL, with comparable clinical outcomes at one year follow up. This could be attributed to a favourable effect of paclitaxel delivery by means of DCB with subsequent late lumen enlargement [29]. Regarding long term clinical outcomes resulting from the use of DCB compared to DES in SvCADs patients, the BELLO [26] and RESTORE SVD [27] studies showed a significant MACE reduction during three and one year follow up respectively in favour of DCB compared to DES. The BASKET-SMALL II trial was the largest RCT evaluating the safety and efficacy of DCB (Sequent Please DCB), versus DES (72% Xience, 28% Taxus) in SvCAD and showed comparable MACE rates between DCB (7.3%) and DES (7.5%) after one year follow-up [30]. Moreover, PICCOLETO II trial [29] supported these clinical findings and did not show any safety signal concerning DCB related to DES in SvCAD at mid-term follow-up, and was consistent with the data provided by BASKET SMALL II [30] and RESTORE SVD trials [27]. Interestingly, this study didn`t show only comparable findings concerning long term clinical outcomes resulting from DCB in treating SvCADs compared to DES, but also showed a significant composite MACE reduction during one year follow up (P < 0.001), specifically in terms of non-fatal MI (P = 0.04), TLR (P < 0.001), and major bleeding (P = 0.03). In the meta-analysis conducted by Li et al [31], the efficacy of DCB and DES in SvCAD patients was compared and indicated that the DCB strategy was associated with decreased risk of non-fatal MI compared with the DES strategy, but there was no significant difference. The present study supported this finding with a significant difference, where non-fatal MI during one year follow up was more frequent in patients with PCI using DES compared to those treated with DCB (P = 0.04). Recently, PEPCAD NSTEMI and REVELATION trials investigated the risk of TLR in DCB versus DES in an ACS setting during nine months follow up. The PEPCAD NSTEMI trial [32] stated that DCB treatment was non-inferior to stent treatment with a TLR rate of 3.8% versus 6.6%. The REVELATION trial [33] also stated that the mean fractional flow reserve was not different between DCB and DES at nine months follow up confirming this non-inferiority of a DCB in relation to DES in ACS patients. Our study results are in line with the findings of the above mentioned trials; but supported these findings in SvCAD setting, where the risk of TLR was more frequent in DES compared to DCB during one year follow up (P < 0.001). This finding could be explained by the avoidance of permanent implants during DCB strategy and therefore preventing stent-related complications [34]. Accordingly, compared with DES, DCB was associated with a decreased risk of stent under expansion, ST, stent fracture, polymer damage, and stent gap. The two and three year follow-up data were recorded for BASKET-SMALL II trial and showed a statistically significant reduction in the risk of major bleeding at two years follow up, with no difference at three years and a trend towards the DEB arm [35]. In line with these findings, the present study showed that the risk of major bleeding was more noted in SvCAD patients with PCI using DES, compared to those treated with DCB (P = 0.03). This is mainly related to the need of long term anticoagulation after DES implantation because the arterial injury resulting from DES implantation could lead to subsequent vaso-proliferative cascade involving smooth muscle cell proliferation and migration and result in neointimal hyperplasia and even ST [34]. Thus, DCB could be a great alternative modality to deliver anti-proliferative materials without using metals and accordingly shorten the anticoagulation period and reduce the risk of major bleeding. Limitations The present study had some limitations. First, it is a single-centre study including a relatively small number of certain patients with SvCAD. Thus, multicentre studies with larger study populations will be needed to confirm the clinical relevance and efficacy of DCB in treating patients with SvCAD. Second, due to cross-sectional nature of this study, some ascertainment bias couldn`t be completely excluded. However, data processing and statistical analyses were performed by independent clinicians and statisticians. Third, these results have been obtained in a centre certified a strong leadership in the use of DCB, therefore it is possible that the results are not reproducible in a different scenario. Finally, the duration of the follow up is relatively short and a longer follow up period is recommended to better assess long term clinical and angiographic outcomes. Conclusions In SvCAD setting, DCB has a favourable angiographic outcome; as evidenced by lower in lesion LLL, in comparison to DES. Also, the application of DCB is associated with significantly reduced rates of composite MACE, non-fatal MI, TLR, and major bleeding at one year follow up, compared to DES. However, DCB doesn`t outperform DES in terms of cardiac death, TVR, and vessel thrombosis. Abbreviations ACS Acute coronary syndrome BARC Bleeding Academic Research Consortium BMS Bare metal stent CAD Coronary artery disease CCS Chronic coronary syndrome DAPT Dual antiplatelet therapy DBP Diastolic blood pressure DCB Drug coated balloon DES Drug eluting stent DM Diabetes mellitus ECG Electrocardiogram eGFR Estimated glomerular filtration rate GP IIb/IIIa Glycoprotein IIb/IIIa HbA1C Glycated haemoglobin ISR In-stent restenosis IST In-stent thrombosis LAD Left anterior descending coronary artery LCX Left circumflex coronary artery LDL-C Low density lipoprotein cholesterol LLL Late lumen loss MACE Major adverse cardiac events MI Myocardial infarction MLD Minimum lumen diameter OGTT Oral glucose tolerance test PCI Percutaneous coronary intervention QCA Quantitative coronary artery analysis RCA Right coronary artery RVD Reference vessel diameter SBP Systolic blood pressure ST Stent thrombosis SvCAD Small vessel coronary artery disease TGs Triglycerides TIMI Thrombolysis in myocardial infarction TLR Target lesion revascularization TVR Target vessel revascularization Declarations Acknowledgments Not applicable. Authors` contributions HR was concerned with conceptualization, methodology, software, data curation, resources, formal analysis and original draft preparation. MA was concerned with data collection, visualization, investigation, supervision, validation and reviewing the final manuscript. Funding Open access funding was provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). This study did not receive funding from external sources. Availability of data and materials The data that support the findings of this study are available from the corresponding author upon reasonable request. Ethical approval and consent to participate Not applicable. Consent for publication Not applicable. Competing interests The authors declare no competing interests. Author details 1 Department of Cardiology, Faculty of Medicine, Zagazig University, Sharkia Governorate, Zagazig 44519, Egypt. 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Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: the task force on myocardial revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014; 35(37):2541-619. Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, et al. Third universal definition of myocardial infarction. Eur Heart J. 2012; 33(20):2551-67. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011; 123(23):2736-47. Biondi-Zoccai G, Moretti C, Abbate A, Sheiban I. Percutaneous coronary intervention for small vessel coronary artery disease. Cardiovasc Revasc Med. 2010; 11(3):189-98. Mauri L, Orav EJ, Kuntz RE. Late loss in lumen diameter and binary restenosis for drug-eluting stent comparison. Circulation. 2005; 111(25):3435-42. Cannon LA, Simon DI, Kereiakes D, Jones J, Mehran R, Kusano H, Zhang Z, Lombardi W, James Fleischhauer F, Costa MA. The XIENCE nano everolimus eluting coronary stent system for the treatment of small coronary arteries: the SPIRIT Small Vessel trial. Catheter Cardiovasc Interv. 2012; 80(4):546-53. Kereiakes DJ, Smits PC, Kedhi E, Parise H, Fahy M, Serruys PW, Stone GW. Predictors of death or myocardial infarction, ischaemic-driven revascularisation, and major adverse cardiovascular events following everolimus-eluting or paclitaxel-eluting stent deployment: pooled analysis from the SPIRIT II, III, IV and COMPARE trials. EuroIntervention. 2011; 7(1):74-83. Cortese B, Micheli A, Picchi A, Coppolaro A, Bandinelli L, Severi S, Limbruno U. Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. Heart. 2010; 96(16):1291-6. . Cortese B. The PICCOLETO study and beyond. EuroIntervention. 2011; 7 Suppl K:K53-6. Silverio A, Buccheri S, Venetsanos D, Alfredsson J, Lagerqvist B, Persson J, Witt N, James S, Sarno G. Percutaneous treatment and outcomes of small coronary vessels: a SCAAR report. JACC Cardiovasc Interv. 2020; 13(7):793-804. . Latib A, Ruparelia N, Menozzi A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, et al. 3-Year follow-up of the balloon elution and late loss optimization study (BELLO). JACC Cardiovasc Interv. 2015; 8(8):1132-4. Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, et al. Drug-coated balloon versus drug-eluting stent for small vessel disease: the RESTORE SVD China randomized trial. JACC Cardiovasc Interv. 2018; 11(23):2381-92. Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-coated balloon for de novo coronary artery disease: JACC state-of-the-art review. J Am Coll Cardiol. 2020; 75(9):1061-73. Cortese B, Di Palma G, Guimaraes MG, Piraino D, Orrego PS, Buccheri D, Rivero F, Perotto A, Zambelli G, Alfonso F. Drug-coated balloon versus drug-eluting stent for small coronary vessel disease: PICCOLETO II randomized clinical trial. JACC Cardiovasc Interv. 2020; 13(24):2840-9. Jeger RV, Farah A, Ohlow MA, Mangner N, Möbius-Winkler S, Leibundgut G, Weilenmann D, Wöhrle J, Richter S, Schreiber M, et al. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018; 392(10150):849-56. Li M, Guo C, Lv YH, Zhang MB, Wang ZL. Drug-coated balloon versus drug-eluting stent in de novo small coronary vessel disease: a systematic review and meta-analysis. Medicine (Baltimore). 2019; 98(21):e15622. Scheller B, Ohlow MA, Ewen S, Kische S, Rudolph TK, Clever YP, Wagner A, Richter S, El-Garhy M, Böhm M, et al. Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention. 2020; 15(17):1527-33. Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction: the REVELATION randomized trial. JACC Cardiovasc Interv. 2019; 12(17):1691-9. Wu X, Li L, He L. Drug-coated balloon versus drug-eluting stent in patients with small-vessel coronary artery disease: a meta-analysis of randomized controlled trials. Cardiol Res Pract. 2021; 2021:1647635. Jeger RV, Farah A, Ohlow MA, Mangner N, Möbius-Winkler S, Weilenmann D, Wöhrle J, Stachel G, Markovic S, Leibundgut G, et al. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020; 396(10261):1504-10. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4659117","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":322849440,"identity":"b058eb5b-ecaa-46bd-94a2-19f3561b594b","order_by":0,"name":"Hesham Refaat","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1klEQVRIiWNgGAWjYBACAwYGNiAlwc8P5rKRoEVyZgOJWhgkNxwgVou59PFnDz7usZAwPn/GgOFD2WEGfv4F+LVY9uWYG854JiFhduCMAeOMc4cZJGc8IOCwMzxs0jwHJOrMDvYYMPO2HWYwuHGAkBb2Z9J/DkhIGDfzGDD/BWqxJ6yFwUyaAajFgA2ohRFkC38DQYeZSfYAtUicYSs42HMunUfiBn4dYIdJ/DhQJ8Hff3jjgx9l1nL8/QQchgJAankYJBJI0AIB/KTYMgpGwSgYBSMBAADIdD+1Vd4vcQAAAABJRU5ErkJggg==","orcid":"","institution":"Zagazig University","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Hesham","middleName":"","lastName":"Refaat","suffix":""},{"id":322849441,"identity":"1c789adf-0fcb-4580-b44e-2eb6487c1d41","order_by":1,"name":"Mohamed Arab","email":"","orcid":"","institution":"Zagazig University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Mohamed","middleName":"","lastName":"Arab","suffix":""}],"badges":[],"createdAt":"2024-06-29 11:38:23","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4659117/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4659117/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":61009341,"identity":"e4da927b-f2f5-4008-9f87-e9fc6a521d7c","added_by":"auto","created_at":"2024-07-24 14:18:19","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":31525,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eOutcomes of DCB versus DES in small vessel coronary artery disease.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e(a) \u003c/strong\u003ePrimary endpoints: late lumen loss is significantly higher in DES compared to DCB (0.14 ± 0.17 mm vs. 0.06 ± 0.12 mm, P=0.004). \u003cstrong\u003e(b) \u003c/strong\u003eSecondary endpoints: composite MACE are significantly higher in DES compared to DCB (P=0.004). Moreover, non-fatal MI (P=0.04), TLR (P\u0026lt;0.001) and major bleeding (P=0.03) are significantly higher in DES compared to DCB.\u003c/p\u003e\n\u003cp\u003eAbbreviations: DCB, drug coated balloon; DES, drug eluting stent; MACE, major adverse cardiac event(s); MI, myocardial infarction; TLR, target lesion revascularization; TVR, target vessel revascularization.\u003c/p\u003e","description":"","filename":"Onlinedrawingimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-4659117/v1/66c96b19b9ecd7412e179e10.png"},{"id":63978603,"identity":"e90ab73e-8630-4778-b84c-b7f9a609d76b","added_by":"auto","created_at":"2024-09-04 12:59:26","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":856389,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4659117/v1/85d79dad-2d9a-45a6-927f-a2ede037dd37.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Long term outcomes of drug-coated balloons versus drug-eluting stents in patients with small vessel coronary artery disease","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe overall percutaneous interventions for coronary artery disease (CAD) have a dramatic progress over the last few decades. Drug-eluting stents (DES) were normative care of coronary stenosis described in 2002 and then experienced a great technical improvement leading to reduced rates of in-stent restenosis (ISR) in relation to bare metal stents (BMS) [1].\u003c/p\u003e \u003cp\u003eHowever, despite improving clinical outcomes with the latest generation DES, their efficacy was limited by both stent thrombosis (ST) and ISR especially when deployed in small vessel coronary artery disease (SvCAD) [2]. The incidence of late ST could be attributed to inflammation, delayed healing and endothelial dysfunction. Thus, DESs did not remove the risk of ISR, but only reduced it necessitating a longer duration of dual antiplatelet therapy [3].\u003c/p\u003e \u003cp\u003eIn particular, the SvCAD could be considered as a significant risk factor for adverse outcomes following percutaneous coronary intervention (PCI). In recent studies, SvCVD has been defined as an angiographic reference vessel diameter of less than 3 mm [4]. It is often diffuse and multi-vessel on presentation and is associated with this higher risk of ISR and ST conferring worse outcomes, higher rates of major adverse cardiac events (MACE) and target lesion failure after PCI [5].\u003c/p\u003e \u003cp\u003eSubsequently, the possibility to treat SvCAD without implanting a permanent prosthesis by means of direct delivery of an anti-proliferative drug through drug-coated balloons (DCB) has been considered appealing since the initial results of this strategy were published ten years ago [6]. Of note, the best practice guidelines on the management of SvCAD interventions remain limited.\u003c/p\u003e \u003cp\u003eThe DCBs are a novel and evolving technology leading to revascularization without leaving a foreign body and provides an attractive alternative in treating SvCAD. They are designed as semi-compliant balloon catheters coated in lipophilic anti-proliferative drugs and deliver the anti-proliferative drugs into vascular wall without implanting stents. Thus, DCBs have emerged as a viable alternative for some specific clinical settings; including high bleeding risk, ISR and de novo coronary lesions particularly in SvCAD [7].\u003c/p\u003e \u003cp\u003eClinical data on the application of DCBs in treating CAD; particularly acute coronary syndrome (ACS), are scarce with nonrandomized clinical studies revealing the feasibility and safety of this approach [8]. The DCBs are currently recommended in the European Society of Cardiology guidelines as class IA for treating ISR [9]. However, the application of DCB for patients with SvCAD remains controversial because different studies have obtained conflicting conclusions. Moreover, despite the widespread use of DCB, their post-marketing analysis has been limited to one year follow-up, and adequately powered randomized clinical studies including long-term follow-up to study clinical outcomes with DCB versus DES treatment in SvCAD are not available [10]. The aim of this study was to assess the angiographic efficacy and long term clinical outcomes of this DCB as compared with DES in patients with SvCAD.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy population\u003c/h2\u003e \u003cp\u003eBetween March 2023 and April 2024, a total of 132 CAD patients who were hospitalized for chronic coronary syndrome (CCS) or ACS and underwent PCI; either by DES or DCB, of de novo culprit lesions in native coronary arteries at our Institution were enrolled in this study.\u003c/p\u003e \u003cp\u003eThe inclusion angiographic characteristics were SvCAD with less than 3 mm diameter and more than 70% stenosis based on visual estimation. Other inclusion criteria were complete reporting of angiographic and clinical outcomes during one year follow up such as late lumen loss (LLL), vessel thrombosis, major bleeding, all-cause death and MACE including non-fatal myocardial infarction (MI), cardiac death, target vessel revascularization (TVR), target lesion revascularization (TLR). Concomitant PCI of coronary lesions more than 3 mm in diameter or ISR in the same epicardial coronary artery, inability to provide informed consent, loss of systematic follow-up, life expectancy less than 2 months, and pregnancy led to exclusion of 32 patients from this study. Thus, 100 patients were finally included in our study.\u003c/p\u003e \u003cp\u003eThe patients were categorized into two main groups; those with PCI to SvCAD using DES and others treated with DCB. The study was carried out in adherence to the principles of the Declaration of Helsinki on Biomedical Research Involving Human Subjects. The institutional Ethics Committee approved the study protocol. All study participants gave written informed consent before the procedure.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eClinical data collection\u003c/h2\u003e \u003cp\u003e Baseline demographics and clinical characteristics of enrolled patients were obtained from our hospital records. Cardiovascular risk factors of these patients were identified. The diagnostic criteria of diabetes mellitus (DM) were confirmed in those patients already receiving active treatment or having fasting glucose\u0026thinsp;\u0026ge;\u0026thinsp;126 mg/dL or glycated haemoglobin (HbA1C)\u0026thinsp;\u0026ge;\u0026thinsp;6.5% or impaired oral glucose tolerance test (OGTT) with 2h glucose\u0026thinsp;\u0026ge;\u0026thinsp;200 mg/dL. Hypertensive patients were defined as those taking antihypertensive therapy or those with systolic blood pressure (SBP)\u0026thinsp;\u0026gt;\u0026thinsp;140 mmHg and/or a diastolic blood pressure (DBP)\u0026thinsp;\u0026gt;\u0026thinsp;90 mmHg. Dyslipidemia was diagnosed with a total cholesterol level\u0026thinsp;\u0026gt;\u0026thinsp;200 mg/dL or low-density lipoprotein cholesterol (LDL-C)\u0026thinsp;\u0026gt;\u0026thinsp;100 mg/dL, or when the patients were already on lipid-lowering therapy according to Adult Treatment Panel III Guidelines [11]. Family history of premature CAD was defined as the presence of CAD in the first-degree relatives before 55 years old for men and 65 years old for women. Patients using tobacco products and those with smoking cessation within one month could be considered smokers [12].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eBlood samples and laboratory analysis\u003c/h2\u003e \u003cp\u003eVenous blood samples were withdrawn from all patients on admission prior to coronary angiography. The following laboratory parameters were obtained: complete blood count, lipid profile, creatinine level, and estimated glomerular filtration rate (eGFR) [13].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eElectrocardiogram (ECG) analysis and echocardiography protocol\u003c/h2\u003e \u003cp\u003eA resting ECG was obtained from all patients on admission. Comprehensive echocardiographic examinations were performed before coronary angiography by well-trained echocardiographers according to the standard recommendations of the American Society of Echocardiography [14].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eCoronary angiography protocol\u003c/h2\u003e \u003cp\u003eCoronary angiography was done at our catheterization laboratory via radial or femoral access using 6 or 7 Fr sheaths and catheters with administrating 0.2 mg of intracoronary nitroglycerin. Multiple projections were used for adequate analysis of target lesions characteristics by two experienced blinded interventional cardiologists.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003ePCI protocol\u003c/h2\u003e \u003cp\u003e All patients were treated according to standardized PCI guidelines including the peri-procedural and subsequent antithrombotic regimen [15]. Angiographic success was defined as final stenosis\u0026thinsp;\u0026lt;\u0026thinsp;30% in the DCB arm and \u0026lt;\u0026thinsp;20% in the DES arm, without major, flow-limiting dissections and Thrombolysis In Myocardial Infarction flow grade 3 (TIMI 3). Procedural success was defined as angiographic success and the absence of in-hospital cardiovascular complications.\u003c/p\u003e \u003cp\u003eIn case of PCI with DES, lesion preparation with balloon pre-dilatation, post-dilatation to ensure optimal angiographic results and using glycoprotein IIb/IIIa (GP IIb/IIIa) receptor antagonists were selectively used according to the operator\u0026rsquo;s judgment. In case of PCI with DCB, lesion preparation was mandatory before DCB inflation. The DCB should be 2 to 3 mm longer on each side than the pre-dilatation balloon to avoid geographic mismatch. The DCB should be inflated at its nominal inflation pressure for at least 30 seconds. If this resulted in major flow limiting dissection or residual stenosis\u0026thinsp;\u0026gt;\u0026thinsp;30% after its use, stenting with DES could be considered\u003c/p\u003e \u003cp\u003eAfter PCI, a dual antiplatelet therapy (DAPT) was prescribed using acetylsalicylic acid (100 mg/d) and either clopidogrel (75 mg/d) or ticagrelor (90 mg twice per day). DAPT was continued for 4 weeks after DCB or 6 months after DES in CCS and for 12 months in ACS. In case of a combination of DCB and DES, DAPT was recommended for 6 months. In patients with oral anticoagulation, current guidelines were followed irrespective of DCB or DES treatment [16]. All patients were discharged with a scheduled angiographic assessment and regular clinical visits during one year follow up.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eAngiographic analysis and follow up\u003c/h2\u003e \u003cp\u003eBaseline and follow-up coronary angiographies were assessed in an independent core lab. Two orthogonal angiographic views were performed during admission, after PCI, and during one year follow-up maintaining similar angulations. Additional views could be required for the precise localization of DCB and DES. Quantitative coronary artery analysis (QCA) was performed for better angiographic analysis.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eClinical outcomes\u003c/h2\u003e \u003cp\u003eAngiographic and clinical outcomes were assessed during one year follow-up with structured clinical questionnaires or phone calls to assess clinical outcomes and medication. The primary endpoint of this study was in-lesion LLL. The secondary endpoints included vessel thrombosis, major bleeding all-cause death and MACEs defined as the composite of cardiac death, non-fatal MI, TLR and TVR.\u003c/p\u003e \u003cp\u003eCardiac death was defined as any death not related extra-cardiac origin. Myocardial infarction was defined according to the recent guidelines [17]. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding [18]. Vessel thrombosis included in-stent thrombosis (IST), ISR, and vascular occlusion. An independent and blinded clinical events committee adjudicated all end points.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eData distribution was first assessed using the Kolgormonov-Smirnov test. Then, categorical data were compared based on the chi-square test or Fisher exact test. Continuous variables were also compared according to an unpaired Student\u0026rsquo;s t-test or Mann\u0026ndash;Whitney U-test. Data were expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. Two-sided statistical tests were achieved with p-value of ˂0.05 representing a statistically significant difference. All these analyses were done using SPSS version 20 (SPSS Inc, Armonk, NY, USA).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 100 CAD patients underwent coronary angiography at our institution with an evidence of SvCAD was enrolled in this study. Subsequently, out of these 100 patients, 50 patients were treated with DCB and the other 50 patients did PCI with DES.\u003c/p\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eDemographical characteristics:\u003c/h2\u003e \u003cp\u003eBaseline demographic characteristics are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. This study population included 63 males (63%) with no significant difference noted between DES and DCB groups (P\u0026thinsp;=\u0026thinsp;0.3). Similarly, no differences were significantly noted between these two groups regarding the mean age of patients (P\u0026thinsp;=\u0026thinsp;0.96). However, family history of CADs was more noted in 48% of patients who did PCI with DES, compared to only 24% of patients treated with DCB (P\u0026thinsp;=\u0026thinsp;0.01). There were no significant differences between two groups regarding other cardiovascular risk factors.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eBaseline characteristics of the studied groups.\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll patients\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;100)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDCB\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDES\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eDemographic characteristics\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eMale sex, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e63 (63%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e29 (58%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e34 (68%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eAge, years\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e59.67\u0026thinsp;\u0026plusmn;\u0026thinsp;9.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59.62\u0026thinsp;\u0026plusmn;\u0026thinsp;10.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e59.72\u0026thinsp;\u0026plusmn;\u0026thinsp;9.66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.96\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eCardiovascular risk factors, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eDiabetes Mellitus\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e51 (51%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22 (44%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e29 (58%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.16\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eHypertension\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e66 (66%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34 (68%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e32 (64%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.67\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eFamily history of CADs\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36 (36%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (24%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24 (48%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eCurrent smoking\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e56 (56%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e31 (62%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.23\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eDyslipidemia\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e59 (59%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33 (66%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26 (52%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.16\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eCKD\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28 (28%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13 (26%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15 (30%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.66\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eClinical characteristics\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eClinical presentation, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eACS\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e71 (71%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e39 (78%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e32 (64%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.12\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eCCS\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29 (29%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (22%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18 (36%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eBlood pressure, mmHg\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eSBP\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e141.6\u0026thinsp;\u0026plusmn;\u0026thinsp;19.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e138.7\u0026thinsp;\u0026plusmn;\u0026thinsp;19.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e144.5\u0026thinsp;\u0026plusmn;\u0026thinsp;18.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.13\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eDBP\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e83.34\u0026thinsp;\u0026plusmn;\u0026thinsp;11.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e82.58\u0026thinsp;\u0026plusmn;\u0026thinsp;12.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e84.1\u0026thinsp;\u0026plusmn;\u0026thinsp;11.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.52\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eHeart rate, b/m\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e78.52\u0026thinsp;\u0026plusmn;\u0026thinsp;11.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e78.46\u0026thinsp;\u0026plusmn;\u0026thinsp;11.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78.58\u0026thinsp;\u0026plusmn;\u0026thinsp;11.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.96\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eTTE parameters\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLVEDD, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e57.94\u0026thinsp;\u0026plusmn;\u0026thinsp;7.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e57.84\u0026thinsp;\u0026plusmn;\u0026thinsp;8.04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e58.04\u0026thinsp;\u0026plusmn;\u0026thinsp;7.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.89\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLVESD, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36.88\u0026thinsp;\u0026plusmn;\u0026thinsp;6.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37.2\u0026thinsp;\u0026plusmn;\u0026thinsp;6.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36.56\u0026thinsp;\u0026plusmn;\u0026thinsp;6.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.63\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLVEF, %\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e51.68\u0026thinsp;\u0026plusmn;\u0026thinsp;11.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e51.28\u0026thinsp;\u0026plusmn;\u0026thinsp;11.48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e52.08\u0026thinsp;\u0026plusmn;\u0026thinsp;10.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.72\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eKILLIP class, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eclass I\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (77%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e41 (82%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36 (72%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003e0.44\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eclass II\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19 (19%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12 (24%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eclass III\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eLaboratory characteristics\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eHemoglobin, gm/dl\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11.2\u0026thinsp;\u0026plusmn;\u0026thinsp;1.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11.28\u0026thinsp;\u0026plusmn;\u0026thinsp;1.87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11.12\u0026thinsp;\u0026plusmn;\u0026thinsp;1.72\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.66\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLeukocytes, x10\u003c/em\u003e\u003csup\u003e\u003cem\u003e3\u003c/em\u003e\u003c/sup\u003e\u003cem\u003e/\u0026micro;L\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.21\u0026thinsp;\u0026plusmn;\u0026thinsp;3.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.39\u0026thinsp;\u0026plusmn;\u0026thinsp;3.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8.02\u0026thinsp;\u0026plusmn;\u0026thinsp;3.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.58\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePlatelets, x10\u003c/em\u003e\u003csup\u003e\u003cem\u003e3\u003c/em\u003e\u003c/sup\u003e\u003cem\u003e/\u0026micro;L\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e296.17\u0026thinsp;\u0026plusmn;\u0026thinsp;98.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e297.46\u0026thinsp;\u0026plusmn;\u0026thinsp;99.77\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e294.88\u0026thinsp;\u0026plusmn;\u0026thinsp;98.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.89\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eTGs, mmol/L\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.1\u0026thinsp;\u0026plusmn;\u0026thinsp;2.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.36\u0026thinsp;\u0026plusmn;\u0026thinsp;1.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.84\u0026thinsp;\u0026plusmn;\u0026thinsp;2.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eTC, mmol/L\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5.91\u0026thinsp;\u0026plusmn;\u0026thinsp;1.21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.93\u0026thinsp;\u0026plusmn;\u0026thinsp;1.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5.88\u0026thinsp;\u0026plusmn;\u0026thinsp;1.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLDL-C, mmol/L\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.46\u0026thinsp;\u0026plusmn;\u0026thinsp;1.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.27\u0026thinsp;\u0026plusmn;\u0026thinsp;1.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.65\u0026thinsp;\u0026plusmn;\u0026thinsp;0.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.06\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eHDL-C, mmol/L\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.1\u0026thinsp;\u0026plusmn;\u0026thinsp;0.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.1\u0026thinsp;\u0026plusmn;\u0026thinsp;0.35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.1\u0026thinsp;\u0026plusmn;\u0026thinsp;0.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.98\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eCreatinine, mmol/L\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.77\u0026thinsp;\u0026plusmn;\u0026thinsp;33.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95.36\u0026thinsp;\u0026plusmn;\u0026thinsp;33.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e96.18\u0026thinsp;\u0026plusmn;\u0026thinsp;34.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eeGFR, ml/min/1.73 m\u003c/em\u003e\u003csup\u003e\u003cem\u003e2\u003c/em\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e50.92\u0026thinsp;\u0026plusmn;\u0026thinsp;13.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e52.76\u0026thinsp;\u0026plusmn;\u0026thinsp;14.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49.08\u0026thinsp;\u0026plusmn;\u0026thinsp;13.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.19\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eAbbreviations: ACS, acute coronary syndrome; CADs, coronary artery diseases; CCS, chronic coronary syndrome; CKD, chronic kidney disease; DBP, diastolic blood pressure; DCB, drug coated balloon; DES, drug eluting stent; eGFR, estimated glomerular filtration rate; HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol; LVEDD, left ventricular end diastolic dimension; LVEF, Left ventricular ejection fraction; LVESD, left ventricular end systolic dimension; SBP, systolic blood pressure; TC, total cholesterol; TGs, triglycerides; TTE, trans-thoracic echocardiogram.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eClinical and laboratory characteristics:\u003c/h2\u003e \u003cp\u003eClinical and laboratory characteristics are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.There was no significant difference regarding the clinical presentation of enrolled patients where ACS was documented in 78% of patients treated with DCB, and 64% of those with PCI using DES (P\u0026thinsp;=\u0026thinsp;0.12). Moreover, there were no significant differences between DCB and DES groups regarding other clinical characteristics. Similarly, there were no significant differences regarding laboratory characteristics apart from significantly elevated triglycerides (TGs) in DES group compared to DCB group (3.84\u0026thinsp;\u0026plusmn;\u0026thinsp;2.88 vs. 2.36\u0026thinsp;\u0026plusmn;\u0026thinsp;1.09 mmol/L, P\u0026thinsp;=\u0026thinsp;0.001).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eLesion and procedural characteristics:\u003c/h2\u003e \u003cp\u003eLesion and procedural characteristics are shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Multi-vessel disease was noted in 31% of all included patients with no significant differences between those treated with DCB and others enrolled in DES group (P\u0026thinsp;=\u0026thinsp;0.52). Similarly, reference vessel diameter (RVD), pre-PCI minimal lumen diameter (MLD) and pre-PCI diameter stenosis were not statistically significant between those two groups (P\u0026thinsp;=\u0026thinsp;0.95, P\u0026thinsp;=\u0026thinsp;0.09, and P\u0026thinsp;=\u0026thinsp;0.17, respectively).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eLesion and procedural characteristics of the studied groups.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll patients\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;100)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDCB\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDES\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLesion characteristics\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eMulti-vessel disease\u003c/em\u003e, \u003cem\u003en (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e31 (31%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (28%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e17 (34%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.52\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eTarget vessel, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"3\" rowspan=\"4\"\u003e \u003cp\u003e0.07\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLAD\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35 (35%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20 (40%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15 (30%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLCX\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e39 (39%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (28%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25 (50%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRCA\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26 (26%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16 (32%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10 (20%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eLesion length, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23.97\u0026thinsp;\u0026plusmn;\u0026thinsp;4.87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28.78\u0026thinsp;\u0026plusmn;\u0026thinsp;5.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e27.3\u0026thinsp;\u0026plusmn;\u0026thinsp;5.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eRVD, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.31\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.31\u0026thinsp;\u0026plusmn;\u0026thinsp;0.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.31\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.95\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePre-PCI MLD, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.89\u0026thinsp;\u0026plusmn;\u0026thinsp;0.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.95\u0026thinsp;\u0026plusmn;\u0026thinsp;0.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.84\u0026thinsp;\u0026plusmn;\u0026thinsp;0.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.09\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePre-PCI diameter stenosis, %\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e86.75\u0026thinsp;\u0026plusmn;\u0026thinsp;6.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e85.8\u0026thinsp;\u0026plusmn;\u0026thinsp;7.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e87.7\u0026thinsp;\u0026plusmn;\u0026thinsp;6.72\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.17\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProcedural characteristics\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePost-PCI MLD, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.31\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.3\u0026thinsp;\u0026plusmn;\u0026thinsp;0.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.32\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.78\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePost-PCI diameter stenosis, %\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13.0\u0026thinsp;\u0026plusmn;\u0026thinsp;12.14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13.5\u0026thinsp;\u0026plusmn;\u0026thinsp;13.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12.5\u0026thinsp;\u0026plusmn;\u0026thinsp;10.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.68\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eAcute gain, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.41\u0026thinsp;\u0026plusmn;\u0026thinsp;0.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.35\u0026thinsp;\u0026plusmn;\u0026thinsp;0.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.48\u0026thinsp;\u0026plusmn;\u0026thinsp;0.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.06\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eProcedure time, minutes\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24.74\u0026thinsp;\u0026plusmn;\u0026thinsp;6.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23.98\u0026thinsp;\u0026plusmn;\u0026thinsp;6.75\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25.5\u0026thinsp;\u0026plusmn;\u0026thinsp;6.18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.24\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eFluoroscopy time, minutes\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16.42\u0026thinsp;\u0026plusmn;\u0026thinsp;5.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17.04\u0026thinsp;\u0026plusmn;\u0026thinsp;5.93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.8\u0026thinsp;\u0026plusmn;\u0026thinsp;5.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.29\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eAmount of contrast, ml.\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e157.85\u0026thinsp;\u0026plusmn;\u0026thinsp;46.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e161.9\u0026thinsp;\u0026plusmn;\u0026thinsp;46.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e153.8\u0026thinsp;\u0026plusmn;\u0026thinsp;46.52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.38\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eDevice length, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28.04\u0026thinsp;\u0026plusmn;\u0026thinsp;5.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e28.78\u0026thinsp;\u0026plusmn;\u0026thinsp;5.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e27.3\u0026thinsp;\u0026plusmn;\u0026thinsp;5.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eDevice size, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.41\u0026thinsp;\u0026plusmn;\u0026thinsp;0.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.31\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.51\u0026thinsp;\u0026plusmn;\u0026thinsp;0.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eInflation pressure, atm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.38\u0026thinsp;\u0026plusmn;\u0026thinsp;2.76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6.78\u0026thinsp;\u0026plusmn;\u0026thinsp;0.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11.98\u0026thinsp;\u0026plusmn;\u0026thinsp;1.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eInflation duration, seconds\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e57.19\u0026thinsp;\u0026plusmn;\u0026thinsp;37.91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e91.7\u0026thinsp;\u0026plusmn;\u0026thinsp;21.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e22.68\u0026thinsp;\u0026plusmn;\u0026thinsp;5.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eAbbreviations: DCB, drug coated balloon; DES, drug eluting stent; LAD, left anterior descending coronary artery; LCX, left circumflex coronary artery; MLD, minimal lumen diameter; PCI, percutaneous coronary intervention; RCA, right coronary artery; RVD, reference vessel diameter.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe left anterior descending coronary artery (LAD) (40% vs. 30%) and right coronary artery (RCA) (32% vs. 20%) were more frequent target vessels in patients treated with DCB, compared to those included in DES, but without statistical significant difference (P\u0026thinsp;=\u0026thinsp;0.07). On the other hand, left circumflex coronary artery (LCX) was the main target vessel in DES group (50% vs. 28%), and similarly without significant differences (P\u0026thinsp;=\u0026thinsp;0.07). Of note, the lesion length was significantly more in DCB group compared to DES group (28.78\u0026thinsp;\u0026plusmn;\u0026thinsp;5.53 vs. 27.3\u0026thinsp;\u0026plusmn;\u0026thinsp;5.33 mm, P\u0026thinsp;=\u0026thinsp;0.02).\u003c/p\u003e \u003cp\u003eRegarding procedural characteristics, DES size were significantly more than DCB size (2.51\u0026thinsp;\u0026plusmn;\u0026thinsp;0.22 vs. 2.31\u0026thinsp;\u0026plusmn;\u0026thinsp;0.28 mm, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). By contrast, DES was not significantly longer than DCB (27.3\u0026thinsp;\u0026plusmn;\u0026thinsp;5.33 vs. 28.78\u0026thinsp;\u0026plusmn;\u0026thinsp;5.53 mm, P\u0026thinsp;=\u0026thinsp;0.18). Moreover, inflation pressure required for DES deployment was significantly higher than that required for DCB inflation (11.98\u0026thinsp;\u0026plusmn;\u0026thinsp;1.13 vs. 6.78\u0026thinsp;\u0026plusmn;\u0026thinsp;0.58 atm, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). On the other hand, prolonged inflation was more significantly noted in DCB group compared to DES group (91.7\u0026thinsp;\u0026plusmn;\u0026thinsp;21.11 vs. 22.68\u0026thinsp;\u0026plusmn;\u0026thinsp;5.32 seconds, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). There were no statistical significant differences regarding other procedural characteristics, specifically acute gain (P\u0026thinsp;=\u0026thinsp;0.06), procedure time (P\u0026thinsp;=\u0026thinsp;0.24), fluoroscopy time (P\u0026thinsp;=\u0026thinsp;0.29), and amount of contrast (P\u0026thinsp;=\u0026thinsp;0.38).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eClinical outcomes at one year follow up:\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e describes clinical outcomes at one year follow up. In-lesion LLL; the primary study endpoint, was significantly lower in DCB arm as compared with DES arm (0.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.12 vs. 0.14\u0026thinsp;\u0026plusmn;\u0026thinsp;0.17 mm, P\u0026thinsp;=\u0026thinsp;0.004). Concurrently, one year clinical follow-up revealed that the composite MACE occurred in 31% of all enrolled patients, with a significant higher incidence in DES group in comparison to DCB group (50% vs. 12%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcomes at one year follow up of the studied groups.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll patients\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;100)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDCB\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eDES\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003ePrimary endpoints\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eIn-lesion late lumen loss, mm\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.09\u0026thinsp;\u0026plusmn;\u0026thinsp;0.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.06\u0026thinsp;\u0026plusmn;\u0026thinsp;0.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.14\u0026thinsp;\u0026plusmn;\u0026thinsp;0.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.004\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSecondary endpoints\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eComposite MACE, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e31 (31%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25 (50%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eCardiac death, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.65\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eNon-fatal MI, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (10%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.04\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eTVR, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eTLR, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23 (23%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e19 (38%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eMajor bleeding, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eVessel thrombosis, n (%)\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (10%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eAbbreviations: DCB, drug coated balloon; DES, drug eluting stent; MACE, major adverse cardiac event(s); MI, myocardial infarction; TLR, target lesion revascularization; TVR, target vessel revascularization.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eSpecifically, the risk of non-fatal MI, TLR, and major bleeding in DES group was significantly higher than DCB group (16% vs. 4%, P\u0026thinsp;=\u0026thinsp;0.04 \u0026amp; 38% vs. 8%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001 \u0026amp; 14% vs. 2%, P\u0026thinsp;=\u0026thinsp;0.03, respectively). However, there was a numerically; but not significantly, higher incidence of cardiac death (6% vs. 4%, P\u0026thinsp;=\u0026thinsp;0.65), and vessel thrombosis (14% vs. 6%, P\u0026thinsp;=\u0026thinsp;0.18) in patients treated with DES, compared to those with PCI using DES. Of note, TVR incidence was similar (2%) in both groups. The primary and secondary endpoints in DCB and DES groups are presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThree major findings arise from this study. (1) DCB has a comparable performance to DES in patients with SvCAD, in terms of procedural characteristics, where there are no significant differences between DCB and DES regarding acute gain, procedure time, fluoroscopy time and contrast volume. (2) Regarding angiographic outcomes within one year after SvCAD revascularization, in lesion LLL is significantly lower in patients treated with DCB, compared to those with PCI using DES. (3) Regarding long term clinical outcomes within one year, composite MACE, non-fatal MI, TLR, and major bleeding are more frequent in patients with PCI using DES. However, DCB doesn`t outperform DES in terms of cardiac death, TVR, and vessel thrombosis.\u003c/p\u003e \u003cp\u003eIt is well known that PCI with DES has been widely used for CAD patients. PCI aims to improve the minimum lumen diameter in a culprit coronary segment [19] with subsequent increase immediately after the procedure but decreases at follow-up. This could be mainly attributed to recoil and hyperplasia phenomena. The amount of this neointimal hyperplasia is mainly independent of the vessel size and SvCAD is more prone to re-stenosis than larger coronary vessels [20].\u003c/p\u003e \u003cp\u003eIn the SvCAD setting, the prospective Spirit SV study reported TLR rate of 10.8% after 13 months with Xience DES [21]. The cumulative data analysis of the SPIRIT and COMPARE studies shows a 2-fold risk of MACE versus larger vessels [22], with a significantly higher risk of MI and TLR. The TWENTE II study showed similar data, with a TLR rate of 9.5% versus 5.4% in larger vessels after two years, and a significantly higher risk of MI and TLR in the SvCAD setting [5].\u003c/p\u003e \u003cp\u003eGiven these limitations of DES in terms of ISR and ST, DCB angioplasty has been shown to be a new revascularization modality for the treatment of SvCAD. To date, only few RCTs compared DCB angioplasty with DES in SvCAD, and thus the aim of this study was to assess the angiographic efficacy and long term clinical outcomes of DCB in treating patients with SvCAD as compared with DES.\u003c/p\u003e \u003cp\u003eThe first DCB generation failed to prove the angiographic non-inferiority versus DES in the prematurely interrupted PICCOLETO trial that was the first RCT to compare DIOR paclitaxel-DCB and Taxus Liberte\u0026acute; paclitaxel-DES in SvCAD [23]. This trial was terminated early due to a higher rate of TLR and MACE after six months. It was hypothesized that these findings could be attributed to lack of efficacy of the used DIOR paclitaxel-DCB that was later replaced by newer generation DCBs [24]. Similarly, SCAAR registry in Sweden between 2009 and 2017 supported this finding and reported an increased restenosis risk in patients undergoing PCI on SvCAD with DCB compared with DES, while there was no difference in all-cause deaths or vessel thrombosis [25].\u003c/p\u003e \u003cp\u003eBy contrast, newer-generation DCB showed the potential advantages of using this modality in treating SvCAD. Regarding angiographic outcomes, the BELLO study documented the angiographic superiority of paclitaxel-DCB (IN.PACT Falcon) versus paclitaxel-DES (Taxus Liberte) in SvCAD patients during three year follow up [26]. Also, RESTORE SVD study showed that the Restore DCB was not inferior to a new generation DES regarding diameter stenosis with also no significant differences regarding LLL during one year follow up. This dramatic benefit of this newer DCB generation could be related to balloon pre-dilatation [27].\u003c/p\u003e \u003cp\u003eConcurrently, the present study revealed a favourable long term angiographic outcomes resulting from DCB, compared to DES in SvCAD patients. During one year follow up, the in-lesion LLL was significantly lower in patients treated with DCB in comparison to those with PCI using DES (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). This could be explained by the fact that DCB delivers anti-proliferative drugs into vascular wall without implanting a stent mediating a suppression role on intimal hyperplasia and inflammation. Moreover, the use of DCB may theoretically overcome the risk of negative vascular remodelling obtained with plain balloon angioplasty, and both the immediate encumbrance and the subsequent neointimal proliferation after stent implantation may be reduced [28].\u003c/p\u003e \u003cp\u003eThe PICCOLETO II study also confirmed this angiographic superiority evidenced by LLL, with comparable clinical outcomes at one year follow up. This could be attributed to a favourable effect of paclitaxel delivery by means of DCB with subsequent late lumen enlargement [29].\u003c/p\u003e \u003cp\u003eRegarding long term clinical outcomes resulting from the use of DCB compared to DES in SvCADs patients, the BELLO [26] and RESTORE SVD [27] studies showed a significant MACE reduction during three and one year follow up respectively in favour of DCB compared to DES. The BASKET-SMALL II trial was the largest RCT evaluating the safety and efficacy of DCB (Sequent Please DCB), versus DES (72% Xience, 28% Taxus) in SvCAD and showed comparable MACE rates between DCB (7.3%) and DES (7.5%) after one year follow-up [30]. Moreover, PICCOLETO II trial [29] supported these clinical findings and did not show any safety signal concerning DCB related to DES in SvCAD at mid-term follow-up, and was consistent with the data provided by BASKET SMALL II [30] and RESTORE SVD trials [27].\u003c/p\u003e \u003cp\u003eInterestingly, this study didn`t show only comparable findings concerning long term clinical outcomes resulting from DCB in treating SvCADs compared to DES, but also showed a significant composite MACE reduction during one year follow up (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), specifically in terms of non-fatal MI (P\u0026thinsp;=\u0026thinsp;0.04), TLR (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), and major bleeding (P\u0026thinsp;=\u0026thinsp;0.03).\u003c/p\u003e \u003cp\u003eIn the meta-analysis conducted by Li et al [31], the efficacy of DCB and DES in SvCAD patients was compared and indicated that the DCB strategy was associated with decreased risk of non-fatal MI compared with the DES strategy, but there was no significant difference. The present study supported this finding with a significant difference, where non-fatal MI during one year follow up was more frequent in patients with PCI using DES compared to those treated with DCB (P\u0026thinsp;=\u0026thinsp;0.04).\u003c/p\u003e \u003cp\u003eRecently, PEPCAD NSTEMI and REVELATION trials investigated the risk of TLR in DCB versus DES in an ACS setting during nine months follow up. The PEPCAD NSTEMI trial [32] stated that DCB treatment was non-inferior to stent treatment with a TLR rate of 3.8% versus 6.6%. The REVELATION trial [33] also stated that the mean fractional flow reserve was not different between DCB and DES at nine months follow up confirming this non-inferiority of a DCB in relation to DES in ACS patients.\u003c/p\u003e \u003cp\u003eOur study results are in line with the findings of the above mentioned trials; but supported these findings in SvCAD setting, where the risk of TLR was more frequent in DES compared to DCB during one year follow up (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). This finding could be explained by the avoidance of permanent implants during DCB strategy and therefore preventing stent-related complications [34]. Accordingly, compared with DES, DCB was associated with a decreased risk of stent under expansion, ST, stent fracture, polymer damage, and stent gap.\u003c/p\u003e \u003cp\u003eThe two and three year follow-up data were recorded for BASKET-SMALL II trial and showed a statistically significant reduction in the risk of major bleeding at two years follow up, with no difference at three years and a trend towards the DEB arm [35]. In line with these findings, the present study showed that the risk of major bleeding was more noted in SvCAD patients with PCI using DES, compared to those treated with DCB (P\u0026thinsp;=\u0026thinsp;0.03).\u003c/p\u003e \u003cp\u003eThis is mainly related to the need of long term anticoagulation after DES implantation because the arterial injury resulting from DES implantation could lead to subsequent vaso-proliferative cascade involving smooth muscle cell proliferation and migration and result in neointimal hyperplasia and even ST [34]. Thus, DCB could be a great alternative modality to deliver anti-proliferative materials without using metals and accordingly shorten the anticoagulation period and reduce the risk of major bleeding.\u003c/p\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eThe present study had some limitations. First, it is a single-centre study including a relatively small number of certain patients with SvCAD. Thus, multicentre studies with larger study populations will be needed to confirm the clinical relevance and efficacy of DCB in treating patients with SvCAD. Second, due to cross-sectional nature of this study, some ascertainment bias couldn`t be completely excluded. However, data processing and statistical analyses were performed by independent clinicians and statisticians. Third, these results have been obtained in a centre certified a strong leadership in the use of DCB, therefore it is possible that the results are not reproducible in a different scenario. Finally, the duration of the follow up is relatively short and a longer follow up period is recommended to better assess long term clinical and angiographic outcomes.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn SvCAD setting, DCB has a favourable angiographic outcome; as evidenced by lower in lesion LLL, in comparison to DES. Also, the application of DCB is associated with significantly reduced rates of composite MACE, non-fatal MI, TLR, and major bleeding at one year follow up, compared to DES. However, DCB doesn`t outperform DES in terms of cardiac death, TVR, and vessel thrombosis.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eACS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eAcute coronary syndrome\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eBARC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eBleeding Academic Research Consortium\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eBMS\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eBare metal stent\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eCAD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eCoronary artery disease\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eCCS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eChronic coronary syndrome\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eDAPT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eDual antiplatelet therapy\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eDBP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eDiastolic blood pressure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eDCB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eDrug coated balloon\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eDES\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eDrug eluting stent\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eDM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eDiabetes mellitus\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eECG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eElectrocardiogram\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eeGFR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eEstimated glomerular filtration rate\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eGP IIb/IIIa\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eGlycoprotein IIb/IIIa\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eHbA1C\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eGlycated haemoglobin\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eISR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eIn-stent restenosis\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eIST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eIn-stent thrombosis\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eLAD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eLeft anterior descending coronary artery\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eLCX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eLeft circumflex coronary artery\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eLDL-C\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eLow density lipoprotein cholesterol\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eLLL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eLate lumen loss\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eMACE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eMajor adverse cardiac events\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eMI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eMyocardial infarction\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eMLD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eMinimum lumen diameter\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eOGTT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eOral glucose tolerance test\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003ePCI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003ePercutaneous coronary intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eQCA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eQuantitative coronary artery analysis\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eRCA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eRight coronary artery\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eRVD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eReference vessel diameter\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eSBP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eSystolic blood pressure\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eST\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eStent thrombosis\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eSvCAD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eSmall vessel coronary artery disease\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eTGs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eTriglycerides\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eTIMI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eThrombolysis in myocardial infarction\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eTLR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eTarget lesion revascularization\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"17.932148626817447%\" valign=\"top\"\u003e\n \u003cp\u003eTVR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"82.06785137318255%\" valign=\"top\"\u003e\n \u003cp\u003eTarget vessel revascularization\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors` contributions\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHR was concerned with conceptualization, methodology, software, data curation, resources, formal analysis and original draft preparation.\u0026nbsp;MA was concerned with data collection, visualization, investigation, supervision, validation and reviewing the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOpen access funding was provided by The Science, Technology \u0026amp; Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). This study did not receive funding from external sources.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical approval and consent to participate\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor details\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003e Department of Cardiology, Faculty of Medicine, Zagazig University, Sharkia Governorate, Zagazig 44519, Egypt.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eParikh SV, Luna M, Selzer F, Marroquin OC, Mulukutla SR, Abbott JD, Holper EM. Outcomes of small coronary artery stenting with bare-metal stents versus drugeluting stents: results from the NHLBI dynamic registry. Catheter Cardiovasc Interv. 2014; 83(2):192-200.\u003c/li\u003e\n \u003cli\u003eKirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, et al. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009; 119(25):3198-206.\u003c/li\u003e\n \u003cli\u003eHelft G. Dual antiplatelet therapy duration after drug-eluting stents: how long? J Thorac Dis. 2016; 8:E844\u0026ndash;6.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eMohiaddin H, Wong TDFK, Burke-Gaffney A, Bogle RG. Drug-coated balloon-only percutaneous coronary intervention for the treatment of de novo coronary artery disease: a systematic review. Cardiol Ther. 2018; 7(2):127-49.\u003c/li\u003e\n \u003cli\u003evan der Heijden LC, Kok MM, Danse PW, Schramm AR, Hartmann M, L\u0026ouml;wik MM, Linssen GC, Stoel MG, Doggen CJ, von Birgelen C. Small-vessel\u0026nbsp;treatment\u0026nbsp;with\u0026nbsp;contemporary\u0026nbsp;newer-generation drug-eluting coronary stents in all-comers: Insights from 2-year DUTCH PEERS (TWENTE II) randomized trial. Am Heart J. 2016; 176:28-35.\u003c/li\u003e\n \u003cli\u003eUnverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, et al. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention. 2013; 9(5):620-8. \u0026nbsp;\u003c/li\u003e\n \u003cli\u003eNijhoff F, Agostoni P, Belkacemi A, Nathoe HM, Voskuil M, Samim M, Doevendans PA, Stella PR. Primary percutaneous coronary intervention by drug-eluting balloon angioplasty: the nonrandomized fourth arm of the DEB-AMI (drug-eluting balloon in ST-segment elevation myocardial infarction) trial. Catheter Cardiovasc Interv. 2015; 86 Suppl 1:S34-44. \u0026nbsp;\u003c/li\u003e\n \u003cli\u003eHo HH, Tan J, Ooi YW, Loh KK, Aung TH, Yin NT, Sinaga DA, Jafary FH, Ong PJ. Preliminary experience with drug-coated balloon angioplasty in primary percutaneous coronary intervention. World J Cardiol. 2015; 7(6):311-4.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eNeumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, et al. 2018 ESC/ EACTS guidelines on myocardial revascularization. Eur Heart J. 2019; 40(2):87-165.\u003c/li\u003e\n \u003cli\u003eVos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-coated balloon angioplasty versus drug-eluting stent in acute myocardial infarction: the REVELATION randomized trial. JACC Cardiovasc Interv. 2019; 12(17):1691-9.\u003c/li\u003e\n \u003cli\u003eNational Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. 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Clinical Nephrology. 2004; 61: 119\u0026ndash;26.\u003c/li\u003e\n \u003cli\u003eLang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, et al.\u0026nbsp;Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015; 28(1):1-39.e14. \u0026nbsp;\u003c/li\u003e\n \u003cli\u003eLevine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, et al. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. 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Cardiol Res Pract. 2021; 2021:1647635.\u003c/li\u003e\n \u003cli\u003eJeger RV, Farah A, Ohlow MA, Mangner N, M\u0026ouml;bius-Winkler S, Weilenmann D, W\u0026ouml;hrle J, Stachel G, Markovic S, Leibundgut G, et al. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020; 396(10261):1504-10.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Drug coated balloon, Drug eluting stent, Small coronary vessels","lastPublishedDoi":"10.21203/rs.3.rs-4659117/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4659117/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eDrug-eluting stents (DES) are a normative care of coronary stenosis. However, their efficacy was limited by stent thrombosis and in-stent restenosis especially in small vessel coronary artery disease (SvCAD). The aim of this study was to assess angiographic efficacy and clinical outcomes of drug coated balloons (DCB) as compared with DES in SvCAD setting.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA total of 100 SvCAD patients with percutaeous angioplasty of culprit coronary arteries\u0026thinsp;\u0026lt;\u0026thinsp;3 mm diameter and \u0026gt;\u0026thinsp;70% stenosis were enrolled in this study. The patients were categorized into DES arm and DCB arm. One year clinical outcomes were assessed. The primary endpoint was in-lesion late lumen loss (LLL). The secondary endpoints were vessel thrombosis, major bleeding, all-cause death and major adverse cardiac events (MACEs).\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOne year clinical follow-up revealed that in-lesion LLL was significantly lower in DCB arm as compared with DES arm (P\u0026thinsp;=\u0026thinsp;0.004). Composite MACE was significantly higher in DES group compared to DCB group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Non-fatal myocardial infarction (MI), target lesion revascularization (TLR), and major bleeding in DES group were significantly higher than DCB group (P\u0026thinsp;=\u0026thinsp;0.04 \u0026amp; P\u0026thinsp;\u0026lt;\u0026thinsp;0.001 \u0026amp; P\u0026thinsp;=\u0026thinsp;0.03, respectively). However, there was a numerically; but not significantly, higher incidence of cardiac death (P\u0026thinsp;=\u0026thinsp;0.65), and vessel thrombosis (P\u0026thinsp;=\u0026thinsp;0.18) in DES arm compared to DES arm.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eIn SvCAD setting, DCB has favourable angiographic and clinical outcomes; as evidenced by lower LLL and composite MACE at one year follow up, compared to DES.\u003c/p\u003e","manuscriptTitle":"Long term outcomes of drug-coated balloons versus drug-eluting stents in patients with small vessel coronary artery disease","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-24 14:18:14","doi":"10.21203/rs.3.rs-4659117/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
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