Outcome of Coronary Edge In-Stent Restenosis management by re-stenting versus Drug Eluting Balloon

Outcome of Coronary Edge In-Stent Restenosis management by re-stenting versus Drug Eluting Balloon | 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 Outcome of Coronary Edge In-Stent Restenosis management by re-stenting versus Drug Eluting Balloon Yasser G. Metwally, Khaled Y. Elnady, Tarek Abd El-Ghaffar, Eman Hesham Seddik, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-1606299/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: The optimal therapeutic strategy for coronary intervention in edge instent restenosis remains less well defined. Aim : To assess 12 months outcome of the Drug–eluting stent Versus Drug-Eluting balloon for managing coronary Edge In-stent restenosis. Methods: 75 patients referred for coronary intervention with edge instent restenosis (edge ISR) were randomly assigned to either Drug eluting stent (DES)or Drug eluting balloon (DEB). The primary endpoint was target vessel revascularization (TVR) at 12 months follow up. Results: significantly lower TVR among the DEB group (0% versus 12.5%, P=0.048). Likewise, Target vessel related myocardial infarction rate was significantly lower among the DEB group (23.1 % versus 1.8 %, P< 0.05). On the other hand; there were no significant differences in the rates of deaths or restenosis between the two groups. Conclusion: The Drug eluting balloon is superior to the Drug eluting stent in management of edge restenosis with better both safety and efficacy. eluting stent eluting balloon coronary stent edge stent restenosis Figures Figure 1 Introduction Edge-ISR represent unique pattern in which a major characteristic is that in most cases the lesion is also involving the adjacent unscaffolded vessel for a variable length ( 1 ); therefore, these patients share characteristic of ISR lesions as well as of classic restenotic lesions after PCI. It is well known that the underlying pathophysiological mechanism of these two lesion categories is largely different. In patients with ISR,stent recoil is absent or negligible and the late lumen loss is almost exclusively the result of neo-intimal tissue inside the stent ( 2 , 3 ), while in patients with restenosis in non-stented vessels, negative vessel remodeling appears to the most relevant factor accounting for appearance of restenosis ( 4 ). Patients And Methods This study was carried out in the Departments of Cardiology, Faculty of Medicine, Zagazig, national heart institute and Maadi armed force hospital. The study was conducted from January 2018 to June 2021. 75 Consecutive patients, aged 18 years and older, diagnosed as "edge ISR" and deemed indicated for coronary intervention were enrolled. Acute coronary syndrome, known intolerance to a P 2 Y 12 receptor blockers that would preclude adherence to dual antiplatelet therapy or intolerance to aspirin, heparin or to antiproliferative agents Everolimus, known pregnancy or a life expectancy of less than one year were exclusion criteria. They were randomly assigned by a computer program (block stratified randomization 5.0, by 5 pianta-dosi). Patients were assigned to receive Xience-V® EES (DES group; n =52) or paclitaxel eluting balloon (DEB group; n = 23). The study complied with the CONSORT 2010 statement (5) and the declaration of Helsinski and was approved by the independent Medical Ethics Committee twenty and the Institution review Board of the participating centre. All patients gave written informed consent. Study devices: The Xience V-EES arm: This study used a Xience V®-EES (Abbott Vascular, Santa Clara, CA, USA). A detailed description of the devices provided elsewhere (http://www.abbottvascular.com/docs/ coronary intervention/xience/epg.xience.pdf) while the drug-eluting balloon arm used a paclitaxel eluting Sequent® balloon (B Braun, Mel-Sungen AG, Germany). The detailed description of this device is provided elsewhere (6 ). Invasive coronary angiography (ICA, QCA) as a reference standard (7). SYNTAX score (8) was calculated. Patients with edge-ISR only were included when stent edge involvement could be documented. The use of several angulated angiographic projections was recommended to establish the relationship between the lesion and stent edge. In addition, our study protocol suggested recruiting stent boost subtract imaging (SBS) to enhance radiologic edge visualization (9). Patients with narrowing affecting the stent margin and extending to the adjacent segment were also eligible according to the standard definition of edge ISR. Coronary interventions were done according to the standard techniques and guidelines (10). During intervention, balloon size was selected to ensure a balloon to artery ratio of 1.1:1 and high pressures (≥ 13 Atm) were recommended for lesion preparation (final pressure for patients, 13 ± 2 Atm). Further medical treatment was provided according to the guidelines and the physician's judgment (11 ) , but the use of dual antiplatelets was mandatory for 12 months. Clinical end-points were defined as proposed by the Academic Research Consortium, including the addendum on myocardial infarction (12,13,11). Death was regarded as cardiac unless an un-equivocal non-cardiac cause could be established. Myocardial infarction was defined by creatinine kinase concentration of more than double the upper limit of normal with raised confirmatory cardiac biomarkers (13). A target vessel related to the target vessel or could not be related to another vessel; further classification could be based on laboratory, ECG, angiographic, or clinical data ( 13,11). Revascularization procedures were considered as clinically indicated (i.e. there was sufficient objective evidence of clinically significant lesion) if the angiographic diameter stenosis of the treated lesion was 50% or more in the presence of ischemic signs or symptoms, or if the diameter stenosis was 70% or more irrespective of ischemic signs or symptoms (13). Stent thrombosis was proposed by the Academic Research Consortium (ARC) (14). A final residual in-segment percent diameter stenosis of less than 30% with TIMI flow III using the assigned device only was defined as procedural success. In-stent restenosis (ISR) was defined was in-stent luminal diameter narrowing of at least 50%. 12-month clinical follow-up data were obtained throughout patients department (OPD) visits or if not feasible, by the telephone follow up using medical questionnaire form. End-points: The primary end-point was target vessel revascularization (TVR) at 12 months follow up. Statistical analysis: The continuous variables were expressed in mean ± SD, while discrete variables were expressed in percentages. The differences in continuous variables were checked for statistical significance by t-test as appropriate, the differences in the discrete variables were checked for statistical significance by X 2 test. All statistical comparisons were two-tailed with significance level of p-value ≤ 0.05 indicates significant, p 0.05 indicates non-significant difference. The statistical analysis was performed using SPSS 11 for windows (SPSS Inc., Chicago, Illinois, USA). Results The baseline, demographic and clinical characteristics of our study population are shown in table 1. No statistically significant differences in the age, gender, BMI, frequency of dyslipidemia, diabetes mellitus, HbA1c, prior MI and EF% between the two groups. On the other hand, hypertension and smoking were more frequent among the patients of the DES group (p were < 0.05 and < 0.05), respectively. Angiographic and procedural variables are shown in table 2. No statistically significant differences in the initial stent length, initial stent diameter, RVD, initial %DS, SYNTAX score, frequency of class B 2 /C complex lesion, follow up %DS, re-restenosis rate (shown in Fig. 1 ), achieved maximum balloon pressure or in the frequency of patients with more than one-vessel disease between the two groups, on the other hand, there was higher frequency of RCA as a target vessel among patients of the DES group (p < 0.05). Clinical outcome variables (at one-year follow up) are shown in table 3. No significant differences in deaths due to cardiac or non-cardiac cause, or in the frequency of patients maintained on dual antiplatelets. On the other hand, there were significantly higher rates of target vessel related MI (p < 0.05), target vessel revascularization (p < 0.05) and stent thrombosis (p < 0.05) among the DES group. Discussion As mentioned earlier, Edge-ISR represents unique pattern in which a major characteristic is that in most cases the lesion is also involving the adjacent unscaffolded vessel for a variable length (1); therefore, these patients share characteristics of ISR lesions as well as of classic restenotic lesion after PCI. It is well known that the underlying pathophysiological mechanism of these two lesion categories is largely different. In patients with ISR, stent recoil is absent or negligible and the late lumen loss is almost exclusively the result of neo-intimal tissue inside the stent (2,3), while in patients with restenosis in non-stented vessels, negative vessel remodeling appears to be the most relevant factor accounting for appearance of restenosis (4). Results of our study demonstrated lower target vessel revascularization rates among the DEB group. The lower TVR rates could be explained in turn by lower target vessel related MI, and stent thrombosis rates among the DEB arm. The good results of strategy of using DEB in "edge-ISR" represent an advantage of providing the drug elution without exposing the target lesion to the risk of new permanent metallic layer (15) or to the polymer content of the new DES used which is a known risk factor for re-ISR.the polymer element of the DES precipitate prolonged inflammatory response in the vessel wall that may induce neointimal hyperplasia leading to re-restenosis (16,17). Another property making DEB being an attractive strategy is that; in case of DES used for treating ISR; the restenosis developed will lead to formation of new permanent metallic layer into the vessel wall especially in re-restenosis. This may lead to further endothelial growth, stent fracture and thrombosis. The meticulous protocol used in both arms to recruit stent boost subtract (SBS) imaging to enhance the radiologic edge visualization (9) as well as the strategy of using a very high dilating pressure for lesions preparation to overcome the un- favorable lesion pathology that specially expected in DES-ISR that appear particularly adverse and frequently includes neo-atherosclerosis (18) have been beneficial in this regard. Previous randomized clinical trials have demonstrated the value of the mechanical device strategy "POBA, repeat stenting, DES and DEB" in ISR management (19,20,21). In the subgroup analysis for ISR of the RiBS study (Fernando Alfonso et al., 2004) comparing repeat stenting versus POBA demonstrated superiority of stenting compared with POBA. Target vessel revascularization rate was 25% versus 22% (p <0.05), whereas the RiBS IV randomized controlled trial (20) comparing DEB with EES for ISR management demonstrated that the EES provided superior long-term results compared with DEB. Target vessel revascularization rates were 16.2% versus 8.4% (p <0-001). Subsequently, Brajraktari et al., had conducted meta-analysis of the outcome of DEB versus DES in DES-ISR management. They concluded similar efficacy and safety outcome for both mechanical devices (21). Alfonso F and colleagues conducted a randomized multicenter trial investigated 150 patients with ISR obtaining either SES or balloon. The primary end point was recurrent restenosis rate at 9 months. They reported lower recurrent restenosis rate among the SES group (11% versus 39%, P< 0.001). They concluded that in patients with ISR the use of SES has a superior long term angiographic as well as clinical outcome (22). RIBS –II study was a randomized trial that investigated the ISR intervention using either SES versus balloon angioplasty where the long term (> 1 year) clinical outcome was tested. they reported that, the event free survival (TVR; MI; death) was better in the SES group (88% versus 69%, P<0.005). they concluded that the SES implantation for ISR is effective and safe at the very long term follow up (23). The RIBS study was a randomized study conducted on 450 patients with ISR using either balloon angioplasty versus elective stenting. the 4 years events free survival was 69% versus 64% (P=0.21) for the stent arm versus the balloon arm respectively. They concluded that in patients with ISR undergoing repeat coronary intervention have a significant event rate on the long term follow up (24). Eltchamonoff et al, reported that, ISR intervention using different ablative techniques following repeat balloon angioplasty including rotational atherectomy, laser, a second stent implantation within the stent or using a cutting balloon were tested. they found that non was superior over the plain balloon angioplasty (25). Three features can make the DEB promising and more attractive alternative to the DES in managing ISR in general. Firstly; the absence of the irritant polymer effect that is a known risk for inducing neointimal hyperplasia and secondly; the alternating metal layers present in case of repeat stenting for the ISR complicated by re-restenosis. Thirdly; those with relatively large-side branches emerging from the stent will not be compromised (20). Conclusion Drug-eluting balloon is superior to Drug-eluting stent for coronary intervention in edge instent restenosis with better both safety and efficacy. Study Limitations Firstly; long term follow up not done. Extended follow up for 3–5 y be needed to assess all possible long-term MACEs. Secondly; clinical outpatients follow up assessment have been preferred than the telephone interview, was not done for all cases. Instead done through over telephone interview. However, the good follow up rate in this study may compensate for such a defect. Thirdly; in small coronary intervention, ISR may be asymptomatic thus may be missed unless follow up angiography is done on routine basis. Finally, only one type DEB being tested in the present study. Testing for the remaining types of DEB is needed. Declarations Acknowledgment: not applicable. Compliance with Ethical standards: *Disclosure of potential conflict of interest: the authors declare that they have no conflict of interest. *Our research involved human participants : the work described has been carried out in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans. * Informed and written consent was obtained from all participants in our research. * The data availability statement: our study data used to support the finding of this study are available from the corresponding author upon request. Financial Disclosure : The study was performed at Zagazig university Hospitals, national heart institute and Maadi armed force hospital with no funding sources. References -Mehran R, Dangas G, Abizaid AS et al (1999) Angiographic pattern of instnt restenosis classification and implications for long-term outcome. Circulation 100:1872–1878. doi: 10.1161/01.CIR.100.18.1872 -Hoffman R, Mintz GS, Dusaillant GR et al (1996) Patterns and mechanisms of in-stent restenosis: A serial intravascular ultrasound study. Circulation 94(6):1247–1254. doi: 10.1161/01.cir.94.6.1247 -Castagna NG, Mintz GS, LeiboffBO et al (2001) The contribution of mechanical problems to in-stent restenosis: An intravascular ultrasonographic analysis of 1090 consecutive in-stent restenosis lesion. Am Heart J 142(6):970–974. doi: 10.1067/mhj.2001.119613 -Mintz GS, Popma JJ, Pichard AD et al (1996) Arterial remodeling after coronary angioplasty: A serial intravascular ultrasound study. Circulation 94(1):35–43. doi: 10.1161/01.cir.94.1.35 -Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT 2010 statement: Updated guidelines for reporting parrelgroup randomized trials. Ann Intern Med 152(11):726–732. doi: 10.7326/0003-4819-152-11-201006010-00232 Epub2010 Mar 24 -Scheller B, Speck U, Bohm M (2007) Prevention of restenosis: Is angioplasty the answer? Heart. 93:539–541. 10.1136/hrt.2007.118059 . 5 -Iskandar A, Limone B, Parker MW et al (2013) Gender differences in the diagnostic accuracy of SPECT myocardial perfusion imaging in patients with left main coronary artery disease. J Nucl Cardiol 20(1):53–63. doi: 10.1007/s12350-012-9646-2 -Sianos G, Morel MA, Kappentein AP, Morice MC et al (2005) The SYNTAX score: An angiographic tool grading the complexity of coronary artery disease. Euro-Intervention 1(2):219–227 PMID: 19758907 -Zhang J, Duan YY, Jin ZG et al (2015) Stent boost subtract imaging for the assessment of optimal stent deployment in coronary ostial lesion intervention comparison with intravascular ultrasound. Int Heart J 56(1):37–42. doi: 10.1536/ihj.14-169 Epub2014 Dec 24 -Banning AP, Baumbach A, Blackman D et al (2015) Percutaneous coronary intervention in the UK: Recommendations for good practice 2015. BM J 101(Issue suppl 31–13. doi: 10.1136/heartnl-2015-307821 -Tandjung K, Basalus MW, Sen H et al (2012) Durable polymer-based stent challenge of Promus Element versus Resolute Integrity (DUTCH PEERS): Rationale and study design of a randomized multicente trial in a Dutch all-comers population. Am Heart J 163(4):557–562. doi: 10.1016/j.ahj.2012.02.001 -Cutlip DE, Windecker S, Mehran R et al (2007) Clinical end-points in coronary stnet trials: A case for standardized definitions. Circulation 115(17):2344–2351. doi: 10.1161/CIRCULATIONAHA-106.685313 -Vranckx P, Cutlip DE, Mehran E et al (2010) Myocardial infarction adjudication in contemporary all-comer stent trials: Balancing sensitivity and specificity. Addendum to the historical MI, definition used in stent studies. Euro Intervention 5(7):871–874. Doi: 10.4244/eijv5i7a146 -Luscher TF, Steffel J, Eberli FR et al (2007) Drug eluting stent and coronary thrombosis: Biological mechanisms and clinical implications. Circulation 115(8):1051–1058. doi: 10.1161/CIRCULATIONAHA.106.675934 -Kawamoto H, Ruparelia N, Latib A, Miyazaki T, Sato K, Mangieri A et al (2015) Drug-coated balloon versus second generation drug eluting stents for the management of recurrent multimetal layered in stent restenosis. JACC CardiovascInterv 8(12):1586–1594. doi: 10.1016/j.jcin.2015.04.032 Epub 2015 sep 17 -van der GIessen WJ, Lincoff AM, Schwartz RS et al (1996) Marked inflammatory sequelae to implantation of biodegradable and non-biodegradable polymers in porcine coronary arteries. Circulation 94(7):1690–1697. doi: 10.1161/01.cir.94.7.1690 -Korowski R, Hong MK, Tio FO, Brumwell O, Wu H, Leon MB (1998) In-stent restenosis: Contributions of inflammatory responses and arterial injury to neointimal hyperplasia. JAm Coll Cardiol 31(1):224–230. doi: 10.1016/s0735-1097(97)00450-6 -Otsuka F, Vorpahl M, Nakano M et al (2014) Pathology of second generation everolimus-eluting stents versus first generation sirolimus-eluting stents and paclitaxel-eluting stents in humans. Circulation129(2):211 – 23. doi: 10.1161/CIRCULATIONAHA.113.001790 .Epub 2013 Oct 25 -Alfonso F, Melgares R, Marinar V et al (2004) Therapeutic implications of in-stent restenosis located at the stent edge: Insights from the restenosis intra-stent balloon angioplasty versus elective stenting (RIBS). Eur Heart J 25:1829–1835. doi: 10.1016/j.ehj.2004.07.019 -Alfonso F, Viscayno M, Cardenas A, del Blanco BG et al 2015 A prospective randomized trial of Drug-rluting Balloons versus eveloms-eluting stents in patients with instent restenosis of drug eluting stents: the RIBS IV randomized trial.J Am Coll Cardiol66(1):23–33doi: 10.1016/j.jacc.2015.04.063 -Brjarkatri G, Jashari H, Ibrahimi P, Alonso F et al (2016) comparison of drug-eluting balloon versus drug-eluting stents treatment of drug eluting stent in-stent restenosis: A meta-analysis of available evidence. Int J cardiolog 218:126–135. doi: 10.1016/j.ijcard.2016.05.040 -Alfonso F, Pérez-Vizcayno MJ, Hernandez R, Bethencourt A et al (2006) RIBS-II InvestigatorsA randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. J Am CollCardiol 47(11):2152–2160. doi: 10.1016/j.jacc.2005.10.078 -Alfonso F, Pérez-Vizcayno MJ, Hernández R, Bethencourt A et al (2008) RIBS-II Investigators.Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study. J Am CollCardiol 52(20):1621–1627. doi: 10.1016/j.jacc.2008.08.025 -Alfonso F, Augé JM, Zueco J, Bethencourt A, López-Mínguez JR et al (2005) RIBS Investigators.,Long-term results (3 to 5 years) of the Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study. J Am CollCardiol 46(5):756–760. doi: 10.1016/j.jacc.2005.05.050 -Eltchaninoff H, Tron C, Sebagh L, Cribier A (2004) Treatment of intrastent restenosis. PatholBiol (Paris) 52(4):218–222. doi: 10.1016/j.patbio.2004.01.011 Tables Table (1): Baseline characteristics of study population DES stent group (n =52) DEB balloon group (n = 23) p value Age 61 ± 11 60 ± 12 0.99 Male gender 42 (80.8%) 18 (78.3%) 0.08 BMI 29 ± 4.2 28.7 ± 5.1 0.79 Hypertension 31 (59.6%) 19 (82.6%) 0.041* Dyslipidemia 27 (51.9%) 12 (52.2%) 0.98 Smoking 12 (23.1%) 4 (17.4%) 0.04* Diabetes mellitus 11 (21.4%) 5 (21.7%) 0.8 Prior MI 11 (21.2%) 5 (21.7%) 0.8 EF% 59 ± 5.2% 58 ± 6.1% 0.46 % of BMS 17 (32.7%) 8 (32.1%) 0.85 Time torestenosis(in days ) 210 ± 50 220 ± 60 0.45 Values are mean ± SD or n (%). *p < 0.05 = Significant Table (2): Angiographic and procedural variables DES stent group (n =52) DEB balloon group (n = 23) p value Target vessel LAD 27 (51.9%) 12 (52.2%) 0.98 CX 10 (19.2%) 5 (21.7%) 0.95 RCA 19 (36.5%) 3 (13%) 0.03* Initial stent length (mm) 18.6 ± 6 18.9 ± 5.6 0.83 Diameter of initial stent 3 ± 10 2.9 ± 11 0.69 QCA analysis 1- RVD (mm) 2.99 ± 0.4 2.99 ± 0.5 0.69 2- % DS a- Before 89.2 ± 25 88 ± 30 0.91 b- Immediately after 6.35 ± 1.5 6.69 ± 1.9 0.4 c-Follow up 31 ± 15 30 ± 16.5 0.39 Restenosis rate 6 (11.5%) 4 (17.4%) 0.74 Syntax score 27 ± 10.6 27.5 ± 8.5 0.83 Complex lesion % (B 2 /C) 17 (32.7%) 7 (30.4%) 0.84 Procedural failure 0 (0%) 0 (0%) 1 Maximum balloon press. 13 ± 3 13.6 ± 2.9 0.42 Number of disease (> 1 vessel) 18 (34.6%) 8 (34.8%) Values are mean ± SD or n (%). *p < 0.05 = Significant Table (3): Clinical outcome at 12 months DES stent group (n =52) DEB balloon group (n = 23) p value Death Non-cardiac 2 (3.8%) 2 (3.6%) 0.76 Cardiac 1 (1.9%) 1 (1.8%) 0.86 Target vessel related MI 12 (23.1%) 1 (1.8%) 0.04* TVR® 12 (23.1%) 1 (1.8%) 0.04* Stent thrombosis 9 (17.3%) 0 (0%) 0.03* % Maintained on dual antiplatelet 52 (100%) 23 (100%) 1 Values are mean ± SD or n (%). *p < 0.05 = Significant ®TVR, all cases did repeat angioplasty 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-1606299","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":102563550,"identity":"f44b95ff-a25b-4730-8afc-3a0e2aace999","order_by":0,"name":"Yasser G. Metwally","email":"","orcid":"","institution":"Zagazig University","correspondingAuthor":false,"prefix":"","firstName":"Yasser","middleName":"G.","lastName":"Metwally","suffix":""},{"id":102563551,"identity":"3ef0a02a-8aed-43c4-a8f2-2cce21201c3a","order_by":1,"name":"Khaled Y. Elnady","email":"","orcid":"","institution":"Millitary Medical Academy","correspondingAuthor":false,"prefix":"","firstName":"Khaled","middleName":"Y.","lastName":"Elnady","suffix":""},{"id":102563552,"identity":"983adda6-d37f-4ce6-b706-4066dc949401","order_by":2,"name":"Tarek Abd El-Ghaffar","email":"","orcid":"","institution":"National Heart Institute","correspondingAuthor":false,"prefix":"","firstName":"Tarek","middleName":"Abd","lastName":"El-Ghaffar","suffix":""},{"id":102563553,"identity":"f468a70b-ff6e-48b6-ba5d-3ad10f41fa0e","order_by":3,"name":"Eman Hesham Seddik","email":"","orcid":"","institution":"Zagazig University","correspondingAuthor":false,"prefix":"","firstName":"Eman","middleName":"Hesham","lastName":"Seddik","suffix":""},{"id":102563554,"identity":"b6314900-e5ad-4694-b5d1-6ee8a0de46e3","order_by":4,"name":"Ahmed Shaker","email":"data:image/png;base64,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","orcid":"","institution":"Zagazig University","correspondingAuthor":true,"prefix":"","firstName":"Ahmed","middleName":"","lastName":"Shaker","suffix":""}],"badges":[],"createdAt":"2022-04-28 22:59:02","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-1606299/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-1606299/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":21027847,"identity":"95c148d0-d871-48f6-b72c-68199143e684","added_by":"auto","created_at":"2022-05-03 15:25:22","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":11681,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eshows the restenosis rate between the studied groups.\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eRestenosis rate\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-1606299/v1/043d5c8d6a603c5c5e6c6a3f.png"},{"id":27833312,"identity":"6d3da499-90ac-4fa0-b58d-1f8ef72ebefe","added_by":"auto","created_at":"2022-10-16 18:44:24","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":582934,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-1606299/v1/05513689-59eb-4cb4-b35f-12a7a5ed85f4.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Outcome of Coronary Edge In-Stent Restenosis management by re-stenting versus Drug Eluting Balloon","fulltext":[{"header":"Introduction","content":"\u003cp\u003eEdge-ISR represent unique pattern in which a major characteristic is that in most cases the lesion is also involving the adjacent unscaffolded vessel for a variable length (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e); therefore, these patients share characteristic of ISR lesions as well as of classic restenotic lesions after PCI. It is well known that the underlying pathophysiological mechanism of these two lesion categories is largely different. In patients with ISR,stent recoil is absent or negligible and the late lumen loss is almost exclusively the result of neo-intimal tissue inside the stent (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e), while in patients with restenosis in non-stented vessels, negative vessel remodeling appears to the most relevant factor accounting for appearance of restenosis (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e"},{"header":"Patients And Methods","content":"\u003cp\u003eThis study was carried out in the Departments of \u0026nbsp; \u0026nbsp;Cardiology, Faculty of Medicine, Zagazig, national heart institute and Maadi armed force hospital. The study was conducted from January \u0026nbsp; 2018 to June 2021.\u003c/p\u003e\n\u003cp\u003e75 Consecutive patients, aged 18 years and older, diagnosed as \u0026quot;edge ISR\u0026quot; and deemed indicated for coronary intervention were enrolled. Acute coronary syndrome, known intolerance to a P\u003csub\u003e2\u003c/sub\u003eY\u003csub\u003e12\u003c/sub\u003e receptor blockers that would preclude adherence to dual antiplatelet therapy or intolerance to aspirin, heparin or to antiproliferative agents Everolimus, known pregnancy or a life expectancy of less than one year were exclusion criteria. They were randomly assigned by a computer program (block stratified randomization 5.0, by 5 pianta-dosi). Patients were assigned to receive Xience-V\u0026reg; EES (DES group; n =52) or paclitaxel eluting balloon (DEB group; n = 23). The study complied with the CONSORT 2010 statement (5) and the declaration of Helsinski and was approved by the independent Medical Ethics Committee twenty and the Institution review Board of the participating centre. All patients gave written informed consent.\u003c/p\u003e\n\u003cp\u003eStudy devices:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThe Xience V-EES arm: This study used a Xience V\u0026reg;-EES (Abbott Vascular, Santa Clara, CA, USA). A detailed description of the devices provided elsewhere (http://www.abbottvascular.com/docs/ coronary intervention/xience/epg.xience.pdf) while the drug-eluting balloon arm used a paclitaxel eluting Sequent\u0026reg; balloon (B Braun, Mel-Sungen AG, Germany). The detailed description of this device is provided elsewhere (6\u003cstrong\u003e).\u003c/strong\u003e\u003c/li\u003e\n \u003cli\u003eInvasive coronary angiography (ICA, QCA) as a reference standard (7).\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eSYNTAX score (8) was calculated. Patients with edge-ISR only were included when stent edge involvement could be documented. The use of several angulated angiographic projections was recommended to establish the relationship between the lesion and stent edge. In addition, our study protocol suggested recruiting stent boost subtract imaging (SBS) to enhance radiologic edge visualization (9).\u003c/p\u003e\n\u003cp\u003ePatients with narrowing affecting the stent margin and extending to the adjacent segment were also eligible according to the standard definition of edge ISR.\u003c/p\u003e\n\u003cp\u003eCoronary interventions were done according to the standard techniques and guidelines (10).\u003c/p\u003e\n\u003cp\u003eDuring intervention, balloon size was selected to ensure a balloon to artery ratio of 1.1:1 and high pressures (\u0026ge; 13 Atm) were recommended for lesion preparation (final pressure for patients, 13 \u0026plusmn; 2 Atm). Further medical treatment was provided according to the guidelines and the physician\u0026apos;s judgment (11\u003cstrong\u003e)\u003c/strong\u003e, but the use of dual antiplatelets was mandatory for 12 months.\u003c/p\u003e\n\u003cp\u003eClinical end-points were defined as proposed by the Academic Research Consortium, including the addendum on myocardial infarction (12,13,11).\u003c/p\u003e\n\u003cp\u003eDeath was regarded as cardiac unless an un-equivocal non-cardiac cause could be established. Myocardial infarction was defined by creatinine kinase concentration of more than double the upper limit of normal with raised confirmatory cardiac biomarkers (13).\u003c/p\u003e\n\u003cp\u003eA target vessel related to the target vessel or could not be related to another vessel; further classification could be based on laboratory, ECG, angiographic, or clinical data \u003cstrong\u003e(\u003c/strong\u003e13,11).\u003c/p\u003e\n\u003cp\u003eRevascularization procedures were considered as clinically indicated (i.e. there was sufficient objective evidence of clinically significant lesion) if the angiographic diameter stenosis of the treated lesion was 50% or more in the presence of ischemic signs or symptoms, or if the diameter stenosis was 70% or more irrespective of ischemic signs or symptoms (13).\u003c/p\u003e\n\u003cp\u003eStent thrombosis was proposed by the Academic Research Consortium (ARC) (14).\u003c/p\u003e\n\u003cp\u003eA final residual in-segment percent diameter stenosis of less than 30% with TIMI flow III using the assigned device only was defined as procedural success. In-stent restenosis (ISR) was defined was in-stent luminal diameter narrowing of at least 50%.\u003c/p\u003e\n\u003cp\u003e12-month clinical follow-up data were obtained throughout patients department (OPD) visits or if not feasible, by the telephone follow up using medical questionnaire form.\u003c/p\u003e\n\u003cp\u003eEnd-points:\u003c/p\u003e\n\u003cp\u003eThe primary end-point was target vessel revascularization (TVR) at 12 months follow up.\u003c/p\u003e\n\u003cp\u003eStatistical analysis:\u003c/p\u003e\n\u003cp\u003eThe continuous variables were expressed in mean \u0026plusmn; SD, while discrete variables were expressed in percentages. The differences in continuous variables were checked for statistical significance by t-test as appropriate, the differences in the discrete variables were checked for statistical significance by X\u003csup\u003e2\u003c/sup\u003e test.\u003c/p\u003e\n\u003cp\u003eAll statistical comparisons were two-tailed with significance level of p-value \u0026le; 0.05 indicates significant, p \u0026lt; 0.001 indicates highly significant difference, while p \u0026gt; 0.05 indicates non-significant difference. The statistical analysis was performed using SPSS 11 for windows (SPSS Inc., Chicago, Illinois, USA).\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThe baseline, demographic and clinical characteristics of our study population are shown in table 1. No statistically significant differences in the age, gender, BMI, frequency of dyslipidemia, diabetes mellitus, HbA1c, prior MI and EF% between the two groups. On the other hand, hypertension and smoking were more frequent among the patients of the DES group (p were \u0026lt;\u0026thinsp;0.05 and \u0026lt;\u0026thinsp;0.05), respectively.\u003c/p\u003e \u003cp\u003eAngiographic and procedural variables are shown in table 2. No statistically significant differences in the initial stent length, initial stent diameter, RVD, initial %DS, SYNTAX score, frequency of class B\u003csub\u003e2\u003c/sub\u003e/C complex lesion, follow up %DS, re-restenosis rate (shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e), achieved maximum balloon pressure or in the frequency of patients with more than one-vessel disease between the two groups, on the other hand, there was higher frequency of RCA as a target vessel among patients of the DES group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eClinical outcome variables (at one-year follow up) are shown in table 3. No significant differences in deaths due to cardiac or non-cardiac cause, or in the frequency of patients maintained on dual antiplatelets. On the other hand, there were significantly higher rates of target vessel related MI (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05), target vessel revascularization (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05) and stent thrombosis (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05) among the DES group.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eAs mentioned earlier, Edge-ISR represents unique pattern in which a major characteristic is that in most cases the lesion is also involving the adjacent unscaffolded vessel for a variable length (1); therefore, these patients share characteristics of ISR lesions as well as of classic restenotic lesion after PCI. It is well known that the underlying pathophysiological mechanism of these two lesion categories is largely different. In patients with ISR, stent recoil is absent or negligible and the late lumen loss is almost exclusively the result of neo-intimal tissue inside the stent (2,3), while in patients with restenosis in non-stented vessels, negative vessel remodeling appears to be the most relevant factor accounting for appearance of restenosis (4).\u003c/p\u003e\n\u003cp\u003eResults of our study demonstrated lower target vessel revascularization rates among the DEB group. The lower TVR rates could be explained in turn by lower target vessel related MI, and stent thrombosis rates among the DEB arm. The good results of strategy of using DEB in \u0026quot;edge-ISR\u0026quot; represent an advantage of providing the drug elution without exposing the target lesion to the risk of new permanent metallic layer (15) or to the polymer content of the new DES used which is a known risk factor for re-ISR.the polymer element of the DES precipitate prolonged inflammatory response in the vessel wall that may induce neointimal hyperplasia leading to re-restenosis (16,17).\u003c/p\u003e\n\u003cp\u003eAnother property making DEB being an attractive strategy is that; in case of DES used for treating ISR; the restenosis developed will lead to formation of new permanent metallic layer into the vessel wall especially in re-restenosis. This may lead to further endothelial growth, stent fracture and thrombosis. The meticulous protocol used in both arms to recruit stent boost subtract (SBS) imaging to enhance the radiologic edge visualization (9) as well as the strategy of using a very high dilating pressure for lesions preparation to overcome the un- favorable lesion pathology that specially expected in DES-ISR that appear particularly adverse and frequently includes neo-atherosclerosis (18) have been beneficial in this regard.\u003c/p\u003e\n\u003cp\u003ePrevious randomized clinical trials have demonstrated the value of the mechanical device strategy \u0026quot;POBA, repeat stenting, DES and DEB\u0026quot; in ISR management (19,20,21).\u003c/p\u003e\n\u003cp\u003eIn the subgroup analysis for ISR of the RiBS study (Fernando Alfonso et al., 2004) comparing repeat stenting versus POBA demonstrated superiority of stenting compared with POBA. Target vessel revascularization rate was 25% versus 22% (p \u0026lt;0.05), whereas the RiBS IV randomized controlled trial (20) comparing DEB with EES for ISR management demonstrated that the EES provided superior long-term results compared with DEB. Target vessel revascularization rates were 16.2% versus 8.4% (p \u0026lt;0-001).\u003c/p\u003e\n\u003cp\u003eSubsequently, Brajraktari et al., had conducted meta-analysis of the outcome of DEB versus DES in DES-ISR management. They concluded similar efficacy and safety outcome for both mechanical devices (21).\u003c/p\u003e\n\u003cp\u003eAlfonso F and colleagues conducted a randomized multicenter trial investigated 150 patients with ISR obtaining either SES or balloon. The primary end point was recurrent restenosis rate at 9 months. They reported lower recurrent restenosis rate among the SES group (11% versus 39%, P\u0026lt; 0.001). They concluded that in patients with ISR the use of SES has a superior long term angiographic as well as clinical outcome (22).\u003c/p\u003e\n\u003cp\u003eRIBS \u0026ndash;II study was a randomized trial that investigated the ISR intervention using either SES versus balloon angioplasty where the long term (\u0026gt; 1 year) clinical outcome was tested. they reported that, the event free survival (TVR; MI; death) was better in the SES group (88% versus 69%, P\u0026lt;0.005). they concluded \u0026nbsp; \u0026nbsp;that the SES implantation for ISR is effective and safe at the very long term follow up (23).\u003c/p\u003e\n\u003cp\u003eThe RIBS study was a randomized study conducted on 450 patients with ISR using either balloon angioplasty versus elective stenting. the 4 years events free survival was 69% versus 64% (P=0.21) for the stent arm versus the balloon arm respectively. They concluded that in patients with ISR undergoing repeat coronary intervention have a significant event rate on the long term follow up (24).\u003c/p\u003e\n\u003cp\u003eEltchamonoff et al, reported that, ISR intervention using different ablative techniques following repeat balloon angioplasty including rotational atherectomy, laser, a second stent implantation within the stent or using a cutting balloon were tested. they found that non was superior over the plain balloon angioplasty (25).\u003c/p\u003e\n\u003cp\u003eThree features can make the DEB promising and more attractive alternative to the DES in managing ISR in general. Firstly; the absence of the irritant polymer effect that is a known risk for inducing neointimal hyperplasia and secondly; the alternating metal layers present in case of repeat stenting for the ISR complicated by re-restenosis. Thirdly; those with relatively large-side branches emerging from the stent will not be compromised (20).\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eDrug-eluting balloon is superior to Drug-eluting stent for coronary intervention in edge instent restenosis with better both safety and efficacy.\u003c/p\u003e\n"},{"header":"Study Limitations","content":"\u003cp\u003eFirstly; long term follow up not done. Extended follow up for 3\u0026ndash;5 y be needed to assess all possible long-term MACEs. Secondly; clinical outpatients follow up assessment have been preferred than the telephone interview, was not done for all cases. Instead done through over telephone interview. However, the good follow up rate in this study may compensate for such a defect. Thirdly; in small coronary intervention, ISR may be asymptomatic thus may be missed unless follow up angiography is done on routine basis. Finally, only one type DEB being tested in the present study. Testing for the remaining types of DEB is needed.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgment:\u003c/strong\u003e not applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompliance with Ethical standards:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e*Disclosure of potential conflict of interest:\u0026nbsp;\u003c/strong\u003ethe authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e*Our research involved human participants\u003c/strong\u003e: the work described has been carried out in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans.\u003c/p\u003e\n\u003cp\u003e*\u003cstrong\u003eInformed and written consent\u003c/strong\u003e was obtained from all participants in our research.\u003c/p\u003e\n\u003cp\u003e*\u003cstrong\u003eThe data availability statement:\u003c/strong\u003e our study data used to support the finding of this study are available from the corresponding author upon request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFinancial\u003c/strong\u003e \u003cstrong\u003eDisclosure\u003c/strong\u003e: The study was performed at Zagazig university Hospitals, national heart institute and Maadi armed force hospital with no funding sources.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003e\u003cspan\u003e-Mehran R, Dangas G, Abizaid AS et al (1999) Angiographic pattern of instnt restenosis classification and implications for long-term outcome. Circulation 100:1872\u0026ndash;1878. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1161/01.CIR.100.18.1872\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Hoffman R, Mintz GS, Dusaillant GR et al (1996) Patterns and mechanisms of in-stent restenosis: A serial intravascular ultrasound study. Circulation 94(6):1247\u0026ndash;1254. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1161/01.cir.94.6.1247\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Castagna NG, Mintz GS, LeiboffBO et al (2001) The contribution of mechanical problems to in-stent restenosis: An intravascular ultrasonographic analysis of 1090 consecutive in-stent restenosis lesion. Am Heart J 142(6):970\u0026ndash;974. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1067/mhj.2001.119613\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Mintz GS, Popma JJ, Pichard AD et al (1996) Arterial remodeling after coronary angioplasty: A serial intravascular ultrasound study. Circulation 94(1):35\u0026ndash;43. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1161/01.cir.94.1.35\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT 2010 statement: Updated guidelines for reporting parrelgroup randomized trials. Ann Intern Med 152(11):726\u0026ndash;732. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.7326/0003-4819-152-11-201006010-00232\u003c/span\u003e\u003c/span\u003eEpub2010 Mar 24\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Scheller B, Speck U, Bohm M (2007) Prevention of restenosis: Is angioplasty the answer? Heart. 93:539\u0026ndash;541. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/hrt.2007.118059\u003c/span\u003e\u003c/span\u003e. 5\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Iskandar A, Limone B, Parker MW et al (2013) Gender differences in the diagnostic accuracy of SPECT myocardial perfusion imaging in patients with left main coronary artery disease. J Nucl Cardiol 20(1):53\u0026ndash;63. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s12350-012-9646-2\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Sianos G, Morel MA, Kappentein AP, Morice MC et al (2005) The SYNTAX score: An angiographic tool grading the complexity of coronary artery disease. Euro-Intervention 1(2):219\u0026ndash;227 PMID: 19758907\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Zhang J, Duan YY, Jin ZG et al (2015) Stent boost subtract imaging for the assessment of optimal stent deployment in coronary ostial lesion intervention comparison with intravascular ultrasound. Int Heart J 56(1):37\u0026ndash;42. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1536/ihj.14-169\u003c/span\u003e\u003c/span\u003eEpub2014 Dec 24\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Banning AP, Baumbach A, Blackman D et al (2015) Percutaneous coronary intervention in the UK: Recommendations for good practice 2015. BM J 101(Issue suppl 31\u0026ndash;13. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/heartnl-2015-307821\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Tandjung K, Basalus MW, Sen H et al (2012) Durable polymer-based stent challenge of Promus Element versus Resolute Integrity (DUTCH PEERS): Rationale and study design of a randomized multicente trial in a Dutch all-comers population. Am Heart J 163(4):557\u0026ndash;562. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ahj.2012.02.001\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Cutlip DE, Windecker S, Mehran R et al (2007) Clinical end-points in coronary stnet trials: A case for standardized definitions. Circulation 115(17):2344\u0026ndash;2351. doi:\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1161/CIRCULATIONAHA-106.685313\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Vranckx P, Cutlip DE, Mehran E et al (2010) Myocardial infarction adjudication in contemporary all-comer stent trials: Balancing sensitivity and specificity. Addendum to the historical MI, definition used in stent studies. Euro Intervention 5(7):871\u0026ndash;874. Doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.4244/eijv5i7a146\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Luscher TF, Steffel J, Eberli FR et al (2007) Drug eluting stent and coronary thrombosis: Biological mechanisms and clinical implications. Circulation 115(8):1051\u0026ndash;1058. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1161/CIRCULATIONAHA.106.675934\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Kawamoto H, Ruparelia N, Latib A, Miyazaki T, Sato K, Mangieri A et al (2015) Drug-coated balloon versus second generation drug eluting stents for the management of recurrent multimetal layered in stent restenosis. JACC CardiovascInterv 8(12):1586\u0026ndash;1594. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jcin.2015.04.032\u003c/span\u003e\u003c/span\u003eEpub 2015 sep 17\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-van der GIessen WJ, Lincoff AM, Schwartz RS et al (1996) Marked inflammatory sequelae to implantation of biodegradable and non-biodegradable polymers in porcine coronary arteries. Circulation 94(7):1690\u0026ndash;1697. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1161/01.cir.94.7.1690\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Korowski R, Hong MK, Tio FO, Brumwell O, Wu H, Leon MB (1998) In-stent restenosis: Contributions of inflammatory responses and arterial injury to neointimal hyperplasia. JAm Coll Cardiol 31(1):224\u0026ndash;230. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/s0735-1097(97)00450-6\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Otsuka F, Vorpahl M, Nakano M et al (2014) Pathology of second generation everolimus-eluting stents versus first generation sirolimus-eluting stents and paclitaxel-eluting stents in humans. Circulation129(2):211 \u0026ndash; 23. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1161/CIRCULATIONAHA.113.001790\u003c/span\u003e\u003c/span\u003e.Epub 2013 Oct 25\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Alfonso F, Melgares R, Marinar V et al (2004) Therapeutic implications of in-stent restenosis located at the stent edge: Insights from the restenosis intra-stent balloon angioplasty versus elective stenting (RIBS). Eur Heart J 25:1829\u0026ndash;1835. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ehj.2004.07.019\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Alfonso F, Viscayno M, Cardenas A, del Blanco BG et al 2015 A prospective randomized trial of Drug-rluting Balloons versus eveloms-eluting stents in patients with instent restenosis of drug eluting stents: the RIBS IV randomized trial.J Am Coll Cardiol66(1):23\u0026ndash;33doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jacc.2015.04.063\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Brjarkatri G, Jashari H, Ibrahimi P, Alonso F et al (2016) comparison of drug-eluting balloon versus drug-eluting stents treatment of drug eluting stent in-stent restenosis: A meta-analysis of available evidence. Int J cardiolog 218:126\u0026ndash;135. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ijcard.2016.05.040\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Alfonso F, P\u0026eacute;rez-Vizcayno MJ, Hernandez R, Bethencourt A et al (2006) RIBS-II InvestigatorsA randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. J Am CollCardiol 47(11):2152\u0026ndash;2160. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jacc.2005.10.078\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Alfonso F, P\u0026eacute;rez-Vizcayno MJ, Hern\u0026aacute;ndez R, Bethencourt A et al (2008) RIBS-II Investigators.Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study. J Am CollCardiol 52(20):1621\u0026ndash;1627. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jacc.2008.08.025\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Alfonso F, Aug\u0026eacute; JM, Zueco J, Bethencourt A, L\u0026oacute;pez-M\u0026iacute;nguez JR et al (2005) RIBS Investigators.,Long-term results (3 to 5 years) of the Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study. J Am CollCardiol 46(5):756\u0026ndash;760. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jacc.2005.05.050\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n \u003cli\u003e\u003cspan\u003e-Eltchaninoff H, Tron C, Sebagh L, Cribier A (2004) Treatment of intrastent restenosis. PatholBiol (Paris) 52(4):218\u0026ndash;222. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.patbio.2004.01.011\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp dir=\"LTR\"\u003e\u003cstrong\u003eTable (1):\u0026nbsp;\u003c/strong\u003eBaseline characteristics of study population\u003c/p\u003e\n\u003cdiv align=\"left\" dir=\"ltr\"\u003e\n \u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eDES\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003estent group\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e(n =52)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eDEB\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eballoon group\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e(n = 23)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003ep value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Age\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e61 \u0026plusmn; 11\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e60 \u0026plusmn; 12\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.99\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Male gender\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e42 (80.8%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e18 (78.3%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.08\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;BMI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e29\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u0026plusmn; 4.2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e28.7\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u0026plusmn; 5.1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.79\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Hypertension\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e31 (59.6%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e19 (82.6%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.041*\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Dyslipidemia\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e27 (51.9%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e12 (52.2%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.98\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Smoking\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e12 (23.1%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e4 (17.4%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.04*\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Diabetes mellitus\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e11 (21.4%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e5 (21.7%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.8\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Prior MI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e11 (21.2%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e5 (21.7%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.8\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;EF%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e59 \u0026plusmn; 5.2%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e58 \u0026plusmn; 6.1%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.46\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;% of BMS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e17 (32.7%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e8 (32.1%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.85\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"36.267605633802816%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Time torestenosis(in days )\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"23.41549295774648%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e210 \u0026plusmn; 50\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.8943661971831%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e220 \u0026plusmn; 60\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.422535211267604%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.45\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp dir=\"LTR\"\u003eValues are mean \u0026plusmn; SD or n (%).\u003c/p\u003e\n\u003cp dir=\"LTR\"\u003e*p \u0026lt; 0.05 = Significant\u003c/p\u003e\n\u003cp dir=\"LTR\"\u003e\u003cstrong\u003eTable (2): Angiographic and procedural variables\u003c/strong\u003e\u003c/p\u003e\n\u003cdiv align=\"left\" dir=\"ltr\"\u003e\n \u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eDES\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003estent group\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e(n =52)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eDEB\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eballoon group\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e(n = 23)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003ep value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\" valign=\"top\" width=\"100%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Target vessel\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; LAD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e27 (51.9%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e12 (52.2%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.98\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; CX\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e10 (19.2%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e5 (21.7%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.95\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; RCA\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e19 (36.5%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e3 (13%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.03*\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Initial stent length (mm)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e18.6 \u0026plusmn; 6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e18.9 \u0026plusmn; 5.6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.83\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Diameter of initial stent\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e3 \u0026plusmn; 10\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e2.9 \u0026plusmn; 11\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.69\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;QCA analysis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; 1- RVD (mm)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e2.99 \u0026plusmn; 0.4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e2.99 \u0026plusmn;\u003c/strong\u003e0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.69\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; 2- % DS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003ea- \u0026nbsp; \u0026nbsp; \u0026nbsp;Before\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e89.2 \u0026plusmn; 25\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e88 \u0026plusmn; 30\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.91\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eb- Immediately after\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e6.35 \u0026plusmn;\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;1.5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e6.69 \u0026plusmn; 1.9\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003ec-Follow up\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e31 \u0026plusmn; 15\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e30 \u0026plusmn; 16.5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.39\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Restenosis rate\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e6 (11.5%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e4 (17.4%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.74\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eSyntax score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e27\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u0026plusmn; 10.6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e27.5\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u0026plusmn; 8.5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.83\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eComplex lesion % (B\u003csub\u003e2\u003c/sub\u003e/C)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e17 (32.7%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e7 (30.4%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.84\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Procedural failure\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0 (0%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0 (0%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Maximum balloon press.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e13 \u0026plusmn; 3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e13.6 \u0026plusmn; 2.9\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.42\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"39.26056338028169%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Number of disease (\u0026gt; 1 vessel)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"22.359154929577464%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e18 (34.6%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e8 (34.8%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"19.190140845070424%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp dir=\"LTR\"\u003eValues are mean \u0026plusmn; SD or n (%).\u003c/p\u003e\n\u003cp dir=\"LTR\"\u003e*p \u0026lt; 0.05 = Significant\u003c/p\u003e\n\u003cp dir=\"LTR\"\u003e\u003cstrong\u003eTable (3): Clinical outcome at 12 months\u003c/strong\u003e\u003c/p\u003e\n\u003cdiv align=\"left\" dir=\"ltr\"\u003e\n \u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"43.309859154929576%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.774647887323944%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eDES\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003estent group\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e(n =52)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.133802816901408%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eDEB\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003eballoon group\u003c/strong\u003e\u003c/p\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e(n = 23)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"17.781690140845072%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003ep value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\" valign=\"top\" width=\"100%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Death\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"43.309859154929576%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; Non-cardiac\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.774647887323944%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e2 (3.8%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.133802816901408%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e2 (3.6%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"17.781690140845072%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.76\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"43.309859154929576%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; Cardiac\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.774647887323944%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e1 (1.9%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.133802816901408%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e1 (1.8%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"17.781690140845072%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.86\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"43.309859154929576%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Target vessel related MI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.774647887323944%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e12 (23.1%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.133802816901408%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e1 (1.8%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"17.781690140845072%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.04*\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"43.309859154929576%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;TVR\u0026reg;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.774647887323944%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e12 (23.1%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.133802816901408%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e1 (1.8%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"17.781690140845072%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.04*\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"43.309859154929576%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;Stent thrombosis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.774647887323944%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e9 (17.3%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.133802816901408%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0 (0%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"17.781690140845072%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e0.03*\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"43.309859154929576%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e\u0026nbsp;% Maintained on dual antiplatelet\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"20.774647887323944%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e52 (100%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"18.133802816901408%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e23 (100%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"17.781690140845072%\"\u003e\n \u003cp dir=\"LTR\"\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp dir=\"LTR\"\u003eValues are mean \u0026plusmn; SD or n (%).\u003c/p\u003e\n\u003cp dir=\"LTR\"\u003e*p \u0026lt; 0.05 = Significant\u003c/p\u003e\n\u003cp dir=\"LTR\"\u003e\u0026reg;TVR, all cases did repeat angioplasty\u003c/p\u003e\n"}],"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":"eluting stent, eluting balloon, coronary stent edge, stent restenosis","lastPublishedDoi":"10.21203/rs.3.rs-1606299/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1606299/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e The optimal therapeutic strategy for coronary intervention in edge instent restenosis remains less well defined.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eAim\u003c/strong\u003e: To assess 12 months outcome of the Drug–eluting stent Versus Drug-Eluting balloon for managing coronary Edge In-stent restenosis.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003e\u0026nbsp;Methods:\u003c/strong\u003e75 patients referred for coronary intervention with edge instent restenosis (edge ISR) were randomly assigned to either Drug eluting stent (DES)or Drug eluting balloon (DEB). The primary endpoint was target vessel revascularization (TVR) at 12 months follow up.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e significantly lower TVR among the DEB group (0% versus 12.5%, P=0.048). Likewise, Target vessel related myocardial infarction rate was significantly lower among the DEB group (23.1 % versus 1.8 %, P\u0026lt; 0.05). On the other hand; there were no significant differences in the rates of deaths or restenosis between the two groups.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eThe Drug eluting balloon is superior to the Drug eluting stent in management of edge restenosis with better both safety and efficacy.\u003c/p\u003e","manuscriptTitle":"Outcome of Coronary Edge In-Stent Restenosis management by re-stenting versus Drug Eluting Balloon","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-05-03 15:25:21","doi":"10.21203/rs.3.rs-1606299/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","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}}],"origin":"","ownerIdentity":"4f1b0070-d369-441b-b069-2626646a46dc","owner":[],"postedDate":"May 3rd, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2022-10-16T18:44:14+00:00","versionOfRecord":[],"versionCreatedAt":"2022-05-03 15:25:21","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-1606299","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1606299","identity":"rs-1606299","version":["v1"]},"buildId":"_2-kVJe1T_tPrBINL-cwx","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}