Detailed timing of reocclusion and restenosis in endovascular therapy of the femoropopliteal lesions

Detailed timing of reocclusion and restenosis in endovascular therapy of the femoropopliteal lesions | 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 Detailed timing of reocclusion and restenosis in endovascular therapy of the femoropopliteal lesions Kenji Suzuki, Daisuke Ueshima, Kazuki Tobita, Naoki Hayakawa, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7751607/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Background: Drug-eluting device and covered stent have become the mainstream of endovascular therapy for femoropopliteal lesions. Though there have been many reports on the primary patency of each device, there are few detailed data on restenosis and reocclusion. This was a physician-initiated, multicenter, retrospective study. From 7 institutes, 3635 femoropopliteal cases were enrolled in this study. Among them, we studied 2786 cases treated with drug-eluting stent (DES), drug-coated balloon (DCB), covered stent (CS), and bare nitinol stent (BNS). Results : The lesion background for each device was different, with mean lesion lengths of 140 (80-220) mm for BNS, 250 (180-300) mm for CS, 200 (100-260) mm for DES, and 123 (60-216) mm for DCB (P<0.001). Primary patency at 2 years was 62% for BNS, 75% for CS, 74% for DES, and 65% for DCB. Timing of restenosis and reocclusion were also different for each device. Peak restenosis timing was 6-9 months for BNS and DCB, 12-15 months for CS and DES. The timing of reocclusion was 6-9 months for BNS and DES, 3-6 months for CS, and 0-3 months for DCB. Conclusions : Not only were the primary patency for each device different, but the timing of restenosis and reocclusion for each device was also different. Peripheral arterial disease restenosis reocclusion Figures Figure 1 Figure 2 Introduction Recently, drug technology and covered stent (CS) have been developed for the endovascular therapy (EVT) of peripheral arterial disease (PAD) affecting the femoropopliteal arteries. As a results, European Society of Cardiology Guidelines recommend EVT for femoropopliteal lesions < 25 cm in size (#1). Since 2006, bare nitinol stent (BNS) improved primary patency compared to balloon dilatation, but restenosis rates remained high (#2, 3). Then in 2008, favorable result for drug-coated balloon (DCB) was reported (#4), thereafter the effectiveness of DCB has been reported in many cases (#5, 6). Similar to DCB, a drug-eluting stent (DES) reported good results (#7), and over a 5-year period, the effectiveness of primary patency compared to BNS was added (#8). It has also been reported that CS showed favorable outcomes for long lesions, and these results were cited in the guidelines (#9). Primary patency at 1 year for each device is often reported to be around 80% (#7, 10), but CS and DES are often used for longer and chronic total occlusion (CTO) lesion, and have been reported to have higher primary patency (#11, 12). In general, CS and DES seem to have better results, however, DCB is often the first choice for treatment of femoropopliteal lesions, as represented by “leave nothing behind strategy”. One reason may be that reocclusion often worsens the condition. Second, restenosis is often easy to treat and has a good prognosis, while reocclusion is not only difficult to open but also has a poor prognosis (#13, 14, 15, 16, 17). There are several reports on how to prevent reocclusion. The first is the use of interventional tips and the second is the use of antithrombotic agents (# 18, 19, 20). However, because of the problem of bleeding complications, the duration of antithrombotic agents should be shortened. The purpose of this study is to examine in detail the timing of reocclusion and restenosis for each device. MATERIALS AND METHODS Study design Detailed timing of reStenosis and reoCclusiOn timing of endovascular theRapy for femoroPopliteal lesIONs (SCORPION) study is a multicenter, retrospective analysis of a prospectively maintained database. A total of 3635 patients with symptomatic peripheral artery disease (Rutherford category 2 to 6) underwent femoropopliteal EVT between January 2017 and February 2021 at seven cardiovascular centers. A total of 2786 cases with DES, DCB, BNS, and CS as finalizing devices were studied. Treatment procedure Dual antiplatelet therapy was administered before the procedure. Dual antiplatelet therapy was continued a minimum of two months after deployment of DES, a minimum of six months after deployment of CS, and a minimum of one month after use of DCB and BNS. The intervention procedure and device selection were performed at the operator's discretion. The indications for intervention included Rutherford grade 2–6 cases with > 50% diameter stenosis determined by angiography. After unfractionated heparin was injected, a 5F to 7F sheath was introduced. A 0.014-to-0.035-inch guidewire was advanced into the lesion, and balloon dilation was performed. In some patients, thrombus aspiration and catheter direct thrombolysis were performed. Stent deployment was recommended if there was severe dissection, described as NHBLI D-to-F, or > 50% residual stenosis. The patency of the target vessel was evaluated using duplex sonography, computed tomography (CT), or angiography, depending on the recommendations of the Society of Vascular Surgery, every 3 months during the first year, every 6 months, or annually thereafter. Outcome measures and definitions The primary endpoint is the rate of restenosis or reocclusion every 3 months up to 2 years. The secondary outcome measure was primary patency, death, and major adverse limb event. Restenosis was defined as a peak systolic velocity>2.5 on duplex sonography or vessels with >50% diameter stenosis, and reocclusion was defined as no color doppler on duplex or no contrast inflow on CT or contrast in the stent area. BNS included both regular self-expand nitinol stents and SUPERA stent (Abbott Laboratories, Abbott Park, IL, USA). DES was defined as the ELUVIA stent (Boston Scientific, Marlborough, MA, USA) and the ZILVER PTX stent (Cook Corporation, Bloomington, IN, USA). DCBs could enroll all DCBs available in Japan. Statistical analysis Data on baseline characteristics are presented as the mean ± standard deviation (SD) for continuous variables and the frequency (percentage) for categorical variables, if not otherwise mentioned. P < 0.05 was considered significant, and 95% confidence intervals (CIs) were reported as appropriate. In this study, we represented the incidence rates of occlusion and restenosis using histograms, while employing probability density functions to visualize the probabilistic distribution of the timing of each event's occurrence. The probability density function does not directly indicate the probability of a specific value itself, but rather represents the probability that data falls within a certain range. For example, the probability that a measurement falls within a specific range can be determined by integrating the value of the probability density function over that range. Additionally, the probability density function is defined such that its integral over all possible values equals 1. To flexibly estimate the shape of the probability density function without assuming a prior distribution of the data, we employed Kernel Density Estimation. We executed the kernel density estimation using the "geom_density()" function from the R "ggplot2" package. The "geom_density()" function internally utilizes the "density()" function, employing the Gaussian kernel as the kernel function and automatically calculating the bandwidth based on Silverman’s Rule of Thumb. Kernel density estimation is utilized in conjunction with histograms to visualize the data distribution more clearly. In particular, it enables a smooth visualization of the distribution that is less affected by the bins of the histogram, allowing for an intuitive understanding of the characteristics of the data. Result From the total of 3635 patients, 699 were in the BNS group, 211 in the CS group, 550 in the DES group, and 1326 in the DCB group. Cases with multiple devices, such as a mixture of DES and CS, were excluded. The baseline patient characteristics of the patients are shown in Table 1 . Significant differences were found in several parameters, such as more women in the CS group, more Cilostazol administration, and less dyslipidemia. The baseline lesion and procedure characteristics of the patients are shown in Table 2 . Lesion length and CTO rates were 140 mm and 49.9% in the BNS group, 250 mm and 69.2% in the CS group, 200 mm and 56.9% in the DES group, and 123 mm and 26.0% in the DCB group. Some parameters, such as cases involving the popliteal artery and vessel diameter, were also indicated significant differences. However, we did not perform propensity match analysis as well as patient background to show the characteristics in real world data. Table 1 Baseline patient characteristics BNS group CS group DES group DCB group P value n 699 211 550 1326 Gender 533 (76.3%) 130 (61.6%) 402 (73.1%) 923 (69.6%) < 0.001 Age (years) 74.9 ± 9.2 75.5 ± 9.1 74.7 ± 9 .0 73.9 ± 9.2 0.015 Body mass index (kg/m 2 ) 22.8 ± 4.0 22.1 ± 3.5 22.4 ± 3.9 22.7 ± 4.0 0.050 Ambulatory 580 (83.0%) 176 (83.7%) 467 (84.9%) 1108 (83.6%) 0.829 Hypertension 570 (81.5%) 179 (84.8%) 458 (83.4%) 1094 (82.5%) 0.672 Diabetes mellitus 453 (64.8%) 119 (56.4%) 356 (64.7%) 876 (66.1%) 0.059 Hyperlipidemia 454 (64.9%) 104 (49.3%) 353 (64.2%) 867 (65.4%) < 0.001 Smoking (current and past) 505 (72.5%) 128 (64.0%) 406 (73.8%) 934 (70.5%) 0.001 Chronic kidney disease 0.004 eGFR < 60 214 (30.6%) 89 (42.2%) 216 (39.3%) 473 (35.7%) Renal failure on dialysis 238 (34.0%) 57 (27.0%) 158 (28.7%) 467 (35.7%) CAPD 1 (0.1%) 1 (0.5%) 2 (0.4%) 9 (0.7%) Coronary artery disease 349 (49.9%) 116 (55.0%) 269 (48.9%) 665 (50.2%) 0.510 Cerebral vascular disease 147 (21.0%) 38 (18.0%) 123 (22.4%) 324 (24.4% 0.108 Heart failure 165 (23.6%) 31 (14.7%) 120 (21.8%) 299 (22.5%) 0.050 Atrial fibrillation 117 (16.7%) 35 (16.6%) 88 (16.0%) 203 (15.3%) 0.851 Aspirin 554 (79.3%) 178 (84.4%) 430 (78.2%) 1013 (76.4%) 0.054 Thienopiridine 586 (83.8%) 183 (86.7%) 481 (87.5%) 1126 (84.9%) 0.292 Cilostazol 191 (27.3%) 107 (50.7%) 169 (30.7%) 348 (26.2%) < 0.001 Anti-coagulation 112 (16.0%) 42 (19.9%) 84 (15.3%) 219 (16.5%) 0.478 Rutherford classification 0.001 Category 2 78 (11.2%) 51 (24.2%) 59 (10.7%) 160 (12.1%) Category 3 414 (46.0%) 101 (47.9%) 320 (58.2%) 768 (57.9%) Category 4 67 (9.6%) 24 (11.4%) 53 (9.6%) 117 (8.8%) Category 5 125 (17.9%) 31 (14.7%) 105 (19.1%) 250 (18.9%) Category 6 15 (2.1%) 4 (1.9%) 13 (2.4%) 31 (2.3%) Ankle brachial index 0.62 [0.50, 0.73] 0.60 [0.49, 0.72] 0.63[0.50, 0.74] 0.67[0.54, 0.80] < 0.001 Categorical variables are expressed as number and percentage. Continuous variables are indicated as mean ± standard deviation or median (interquartile range). BNS = bare nitinol stent, CS = covered stent, DCB = drug coated balloon, DES = drug eluting stent, GFR = glomerular filtration rate, CAPD = continuous ambulatory peritoneal dialysis Table 2 Baseline lesion characteristics of study population BNS group CS group DES group DCB group P value n 699 211 550 1326 Lesion location < 0.001 SFA 539 (77.1%) 92 (43.6%) 382 (69.5%) 775 (58.4%) Popliteal 65 (9.3%) 12 (5.7%) 105 (19.1%) 240 (18.1%) SFA to popliteal 95 (13.6%) 107 (50.7%) 147 (26.7%) 311 (23.5%) De novo 582 (83.3%) 151 (71.6%) 468 (85.1%) 986 (74.4%) < 0.001 Reference diameter 5.5 [5.0, 6.0] 5.8 [5.5, 6.0] 5.5 [5.0, 6.0] 5.2 [4.7, 5.8] < 0.001 Lesion length 140 [80, 220] 250 [180, 300] 200 [100, 260] 123 [60, 216] < 0.001 CTO 349 (49.9%) 146 (69.2%) 398 (56.9%) 345 (26.0%) < 0.001 CTO length 150 [60, 220] 200 [90, 250] 190 [90, 250] 100 [42, 210] < 0.001 PACSS grade < 0.001 0 230 (32.9%) 76 (36.0%) 205 (37.3%) 551 (41.6%) 1 68 (9.7%) 33 (15.6%) 66 (12.0%) 183 (13.8%) 2 30 (4.3%) 12 (5.7%) 38 (6.9%) 81 (6.1%) 3 103 (14.7%) 21 (10.0%) 71 (12.9%) 179 (13.5%) 4 268 (38.3%) 69 (32.7%) 170 (30.9%) 332 (25.0%) Wire crossing < 0.001 Fluoro 565 (80.8%) 182 (86.3%) 441 (80.2%) 1195 (90.1%) EVUS 36 (5.2%) 19 (9.0%) 32 (5.8%) 38 (2.9%) IVUS 98 (14.0%) 10 (4.7%) 77 (14.0%) 93 (7.0%) Treatment device < 0.001 SUPERA 211 (30.2%) 0 (0.0%) 0 (0.0%) 0 (0.0%) BNS 488 (69.8%) 0 (0.0%) 0 (0.0%) 0 (0.0%) VIABAHN 0 (0.0%) 211 (100.0%) 0 (0.0%) 0 (0.0%) IN.PACT 0 (0.0%) 0 (0.0%) 0 (0.0%) 839 (63.3%) LUTONIX 0 (0.0%) 0 (0.0%) 0 (0.0%) 465 (35.1%) RANGER 0 (0.0%) 0 (0.0%) 0 (0.0%) 9 (0.7%) Other DCB 0 (0.0%) 0 (0.0%) 0 (0.0%) 13 (1.0%) ELUVIA 0 (0.0%) 0 (0.0%) 405 (73.6%) 0 (0.0%) ZILVER PTX 0 (0.0%) 0 (0.0%) 145 (26.4%) 0 (0.0%) Bail out stent - - - 33 (2.5%) Complications 0.001 None 677 (96.9%) 198 (93.8%) 520 (94.5%) 1307 (98.6%) Blood transfusion 2 (0.3%) 1 (0.5%) 1 (0.2%) 1 (0.1%) Distal embolization 6 (0.9%) 4 (1.9%) 7 (1.3%) 7 (0.5%) Perforation 6 (0.9%) 5 (2.4%) 11 (2.0%) 6 (0.5%) Puncture site trouble 8 (1.1%) 3 (1.4%) 11 (2.0%) 5 (0.4%) Categorical variables are expressed as number and percentage. Continuous variables are indicated as mean ± standard deviation or median (interquartile range). SFA = superficial femoral artery, CTO = chronic total occlusion, PACSS = Peripheral Arterial Calcium Scoring System, EVUS = extravascular ultrasound, IVUS = intravascular ultrasound, BTK = below the knee Kaplan-Meier curves of primary patency divided into reocclusion and restenosis were shown in Fig. 1 . Because of the different lesion backgrounds, simple comparisons cannot be made, but the characteristics of restenosis for each device can be found. To clarify these characteristics, separate graphs were made for reocclusion and restenosis every 3 months ( Figure. 2 ). Peak restenosis timing was 6–9 months for BNS and DCB, 12–15 months for CS and DES. The timing of reocclusion was 6–9 months for BNS and DES, 3–6 months for CS, and 0–3 months for DCB. The DCB group has fewer reocclusion, but a relatively high rate of restenosis is present; the DES and CS groups show a relatively same pattern. Particularly within 6 months, there is more reocclusion than restenosis, with a clear peak in restenosis at around 1 year. Clinical results were presented in Table 3 . CS, DCB, and DES had better freedom from TLR rate than BNS, but only DES was significantly better at 2 years. There were no significant differences in major amputation and mortality between the four groups. Table 3 Clinical outcomes BNS group CS group DES group DCB group 699 211 550 1326 TLR 1y event free rate (95%CI). % 0.83 (0.80–0.86) 0.85 (0.79–0.89) 0.91 (0.88–0.94) 0.89 (0.87–0.91) 2y event free rate (95%CI). % 0.72 (0.68–0.76) 0.78 (0.70–0.83) 0.79 (0.74–0.84) 0.75 (0.71–0.78) Hazard ratio (95%CI) vs. BNS control 0.72 (0.50–1.02) 0.72 (0.54–0.96) 0.90 (0.72–1.11) Major amputation 1y event free rate (95%CI). % 0.98 (0.96–0.99) 1.00 (0.96–1.00) 0.98 (0.96–0.99) 0.98 (0.97–0.99) 2y event free rate (95%CI). % 0.97 (0.95–0.98) 0.99 (0.94–1.00) 0.97 (0.95–0.98) 0.97 (0.95–0.98) Hazard ratio (95%CI) vs. BNS control 0.36 (0.08–1.56) 1.04 (0.50–2.17) 0.91 (0.49–1.68) All cause death 1y event free rate (95%CI). % 0.88 (0.85–0.90) 0.93 (0.88–0.96) 0.90 (0.87–0.92) 0.91 (0.89–0.92) 2y event free rate (95%CI). % 0.79 (0.76–0.83) 0.83 (0.76–0.88) 0.81 (0.76–0.85) 0.82 (0.79–0.85) Hazard ratio (95%CI) vs. BNS control 0.85 (0.61–1.20) 0.93 (0.71–1.22) 0.87 (0.70–1.09) TLR = target lesion revascularization, CI = confidence interval Discussion This study examined the performance of various devices in real-world data, categorized by restenosis, reocclusion, and detailed timing. Many studies have already been reported on the results of each device, but there are no reports of detailed data focusing on reocclusion, restenosis, or timing. In general, BNS experiences patency loss in 6 months to 1 year, followed by a slow decline, while DCB is less likely to plateau after 1 year (#7, 21). It is important to note that the DES and CS groups show relatively similar patterns, with patency loss within 6 months being mainly due to reocclusion rather than restenosis. The key is to avoid reocclusion rather than restenosis. Since reocculsion is associated with extremity inferior long-term results (#16) before the drug device was available. Even with the availability of drug devices, results for reocclusion have not been satisfactory (#22). In Japan, where there are few debulking devices available, the high rate of complications, including distal embolization, is also a concern (#13). Moreover, reocclusion treatment is likely to increase stent length (#23). It is therefore crucial to avoid reocclusion, and it has been reported that avoiding scaffold placement in small vessels, plaque landings, and up to popliteal lesions is important (#24). Scaffolds are reported to cause more thrombosis than DCBs, and ALI is also reported to increase (17). However, no significant difference in MA rates was found in this study. Another method to improve patency is pharmacotherapy. In terms of improving long-term result of EVT, there have been several reports with cilostazol (#25, 26). However, these are mainly limited to Scaffold data, and DCB data are scarce. In addition, the efficacy of anticoagulation therapy for PAD has been reported, particularly reducing acute limb ischemia (# 18, 19). In the latest guidelines, anticoagulation is strongly recommended as class of recommendation, Class I, level of evidence, Level A (#27). Thus, anticoagulants have the potential to reduce reocclusion, but DES need a double antiplatelet therapy (DAPT) period of more than 2 months and CS more than 6 months. The problem is that long term period of triple antithrombotic agents. Sub-analysis suggest that DAPT plus anticoagulation for more than 30 days is associated with increased bleeding complications (#20). LEAD patients are often high bleeding risk, and concerns remain about long-term antithrombotic drug administration (#28). Anticoagulation only during periods of high reocclusion with Scaffold implantation might lead to improved outcomes. Hence, it is extremely important to know when reocclusion are most common for each device. In this study, devices were divided into four categories. Although there are reports that SUPERA stent have different patency rates than regular BNS and that ZILVER PTX and ELUVIA have different reocclusion rates (#21, 29). However, too detailed a classification could undermine the essence of this study, so four classifications were used. DCB was the most used in the study, with 1326 cases. Despite having the shortest lesion length as well as the fewest CTOs, primary patency is not the best. The fact that DCB is the most used despite low patency in easy lesions may indicate that reocclusion avoidance is a strong factor in device selection. The key point about patency loss in DCB is that reocclusions were most common in the early stages of treatment. This is most likely not an effect of the drug failure, but a so-called balloon failure. Confirmation of minimal lesion area with intravascular ultrasound, correct evaluation of dissection and bail out stenting may contribute to improved DCB outcomes (#30). Limitations This study has several limitations. First, this study had a multicenter, retrospective, and non-randomized design, causing potential bias. Second, propensity match was not performed, there is variation in patient and lesion backgrounds. Third, the exact duration of drug administration remains unknown and the data are from a period when low-dose rivaroxaban was not available. Fourth, data from multiple devices, such as DCB and DES combination, was excluded. Lastly, clinical follow-ups were performed at each institute; however, no follow-up protocol was established during the study period. Conclusions Not only were the primary patency for each device different, but the timing of restenosis and reocclusion for each device was also different. In order to improve device performance, it will be necessary to understand the timing of restenosis and reocclusion. Declarations Ethics approval and consent to participate The study protocol was approved by the local ethics committee of each participating center, and the study was performed in accordance with the Declaration of Helsinki. The requirement for informed consent was waived because of the retrospective study design and public health exception. Relevant information regarding the research will be disclosed in accordance with the Ethical Guidelines for Medical and Medical Technology Research Involving Human Subjects. Consent for publication For this type of study consent for publication is not required. Availability of data and material The data that support the findings of this study are available from the corresponding author upon reasonable request. The data are not publicly available due to privacy or ethical restrictions. Funding None Conflict of interest KS received remuneration for lecture from Cordis and KANEKA Medix. KT is a consultant of Gore and Boston Scientific, and received honorarium from Gore, Medtronic, Boston Scientific, Kaneka Medics, TERUMO and Becton, Dickinson and Company. NH is a consultant of Reflow medical, and received honoraria from Terumo, Kaneka Medix, Medicos Hirata, Boston Scientific, Medtronic, Cordis, Abbot Vascular and Becton, Dickinson and Company. SM received lecture fee from Becton, Dickinson and Company, and Terumo. TN is a consultant of Becton, Dickinson and Company, Boston Scientific, Century Medical Inc., COOK Medical, Cordis, Kaneka Medix, Asahi Intecc, NIPRO, and OrbusNeich and received lecture fee from Abbot Vascular, Terumo and Medtronic. The other author reports no conflicts of interest. Author contribution KS, DU, KT, NH, SM, YI, KH, and TN contributed to the study concept and design; KS, KT, NH, NH, SM, YI, KH, and TN contributed to data collection, KS and DU contributed to data analysis. 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Midterm Patency After Femoropopliteal Interventions: A Comparison of Standard and Interwoven Nitinol Stents and Drug-Coated Balloons in a Single-Center, Propensity Score–Matched Analysis J Endovasc Ther 2016;23:347-355 Suzuki K, Takahara M, Tobita K, Hayakawa N, Mori S, Iwata Y, et al, Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study Vasc Endovascular Surg 2024;58:693-700 Nagatomi S, Takahara M, Nakai T, Fujimura N, Yu A, Masuda D, et al. Comparing the impact of the loss of patency between treatment with drug-coated balloon angioplasty and drug-eluting stent placement J Vasc Surg 2023;77:1751-1759 Kurata N, Iida O, Takahara M, Asai M, Okamoto S, Ishihara T, et al. Comparing Predictors Influencing Restenosis Following High-Dose Drug-Coated Balloon Angioplasty and Fluoropolymer-Based Drug-Eluting Stenting in Femoropopliteal Artery Lesions J Endovasc Ther 2025; 32: 1194-1204 Iida O, Yokoi H, Soga Y, Inoue N, Suzuki K, Yokoi Y, et al. Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study Circulation 2013;127:2307-15 Tobita K, Takahara M, Iida O, Soga Y, Yamaoka T, Ichihashi S, et al. Clinical Impact of Additional Cilostazol Treatment on Restenosis Risk following Heparin-Bonded Stent Graft Implantation: Sub-Analysis from the Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study J Atheroscler Thromb 2023;30:1461-1470 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, et al J Am Coll Cardiol 2024;83:2497-2604 Spirito A, Cohen R, Sartori S, Vogel B, Baber U, Pileggi B, et al. Prognostic impact of peripheral artery disease in patients with and without high bleeding risk undergoing percutaneous coronary intervention Catheter Cardiovasc Interv 2024;103:425-434 Shibata T, Iba Y, Shingaki M, Yamashita O, Tsubakimoto Y, Kimura F, et al. One Year Outcomes of Zilver PTX Versus Eluvia for Femoropopliteal Disease in Real-World Practice: REALDES Study J Endovasc Ther 2023 Jun 8:15266028231179861 Kodama T, Kuwabara M, Ueshima D, Yamaguchi T, Fujimoto Y, Miyazaki T, et al. Impact of intravascular ultrasound on limb events in endovascular therapy for patients with peripheral arterial disease: insights from the TOMA-CODE registry Cardiovasc Interv and Ther 2025; 40: 344-351 Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 02 Nov, 2025 Reviewers invited by journal 28 Oct, 2025 Editor assigned by journal 28 Oct, 2025 First submitted to journal 24 Oct, 2025 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-7751607","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":536199794,"identity":"1a078ceb-aee2-4ae5-a989-aeb9bd3b4b1d","order_by":0,"name":"Kenji 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1","display":"","copyAsset":false,"role":"figure","size":297399,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meier curves showing recclusion and restenosis for each device\u003c/p\u003e","description":"","filename":"Figure1mono.tiff.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7751607/v1/9417bf4a1b6bc7d1cee0968c.jpg"},{"id":95501287,"identity":"817c58d8-fcea-483e-9972-c7f802b025ef","added_by":"auto","created_at":"2025-11-10 05:27:52","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":270795,"visible":true,"origin":"","legend":"\u003cp\u003eNumber of reocclusion and restenosis every three months\u003c/p\u003e","description":"","filename":"Figure2mono.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7751607/v1/5fd46eb903082d182d90356e.jpg"},{"id":95531611,"identity":"97e25013-52c5-4518-a4e8-8164a44954f3","added_by":"auto","created_at":"2025-11-10 10:23:27","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1286827,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7751607/v1/b234a9ee-7ee4-4522-9c4f-df065de9e70d.pdf"}],"financialInterests":"","formattedTitle":"Detailed timing of reocclusion and restenosis in endovascular therapy of the femoropopliteal lesions","fulltext":[{"header":"Introduction","content":"\u003cp\u003eRecently, drug technology and covered stent (CS) have been developed for the endovascular therapy (EVT) of peripheral arterial disease (PAD) affecting the femoropopliteal arteries. As a results, European Society of Cardiology Guidelines recommend EVT for femoropopliteal lesions\u0026thinsp;\u0026lt;\u0026thinsp;25 cm in size (#1).\u003c/p\u003e\u003cp\u003eSince 2006, bare nitinol stent (BNS) improved primary patency compared to balloon dilatation, but restenosis rates remained high (#2, 3). Then in 2008, favorable result for drug-coated balloon (DCB) was reported (#4), thereafter the effectiveness of DCB has been reported in many cases (#5, 6). Similar to DCB, a drug-eluting stent (DES) reported good results (#7), and over a 5-year period, the effectiveness of primary patency compared to BNS was added (#8). It has also been reported that CS showed favorable outcomes for long lesions, and these results were cited in the guidelines (#9).\u003c/p\u003e\u003cp\u003ePrimary patency at 1 year for each device is often reported to be around 80% (#7, 10), but CS and DES are often used for longer and chronic total occlusion (CTO) lesion, and have been reported to have higher primary patency (#11, 12). In general, CS and DES seem to have better results, however, DCB is often the first choice for treatment of femoropopliteal lesions, as represented by \u0026ldquo;leave nothing behind strategy\u0026rdquo;. One reason may be that reocclusion often worsens the condition. Second, restenosis is often easy to treat and has a good prognosis, while reocclusion is not only difficult to open but also has a poor prognosis (#13, 14, 15, 16, 17).\u003c/p\u003e\u003cp\u003eThere are several reports on how to prevent reocclusion. The first is the use of interventional tips and the second is the use of antithrombotic agents (# 18, 19, 20). However, because of the problem of bleeding complications, the duration of antithrombotic agents should be shortened.\u003c/p\u003e\u003cp\u003eThe purpose of this study is to examine in detail the timing of reocclusion and restenosis for each device.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy design\u003c/h2\u003e\u003cp\u003eDetailed timing of reStenosis and reoCclusiOn timing of endovascular theRapy for femoroPopliteal lesIONs (SCORPION) study is a multicenter, retrospective analysis of a prospectively maintained database. A total of 3635 patients with symptomatic peripheral artery disease (Rutherford category 2 to 6) underwent femoropopliteal EVT between January 2017 and February 2021 at seven cardiovascular centers. A total of 2786 cases with DES, DCB, BNS, and CS as finalizing devices were studied.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eTreatment procedure\u003c/h3\u003e\n\u003cp\u003eDual antiplatelet therapy was administered before the procedure. Dual antiplatelet therapy was continued a minimum of two months after deployment of DES, a minimum of six months after deployment of CS, and a minimum of one month after use of DCB and BNS. The intervention procedure and device selection were performed at the operator's discretion. The indications for intervention included Rutherford grade 2\u0026ndash;6 cases with \u0026gt;\u0026thinsp;50% diameter stenosis determined by angiography. After unfractionated heparin was injected, a 5F to 7F sheath was introduced. A 0.014-to-0.035-inch guidewire was advanced into the lesion, and balloon dilation was performed. In some patients, thrombus aspiration and catheter direct thrombolysis were performed. Stent deployment was recommended if there was severe dissection, described as NHBLI D-to-F, or \u0026gt;\u0026thinsp;50% residual stenosis. The patency of the target vessel was evaluated using duplex sonography, computed tomography (CT), or angiography, depending on the recommendations of the Society of Vascular Surgery, every 3 months during the first year, every 6 months, or annually thereafter.\u003c/p\u003e\n\u003ch3\u003eOutcome measures and definitions\u003c/h3\u003e\n\u003cp\u003eThe primary endpoint is the rate of restenosis or reocclusion every 3 months up to 2 years. The secondary outcome measure was primary patency, death, and major adverse limb event. Restenosis was defined as a peak systolic velocity\u0026gt;2.5 on duplex sonography or vessels with \u0026gt;50% diameter stenosis, and reocclusion was defined as no color doppler on duplex or no contrast inflow on CT or contrast in the stent area. BNS included both regular self-expand nitinol stents and SUPERA stent (Abbott Laboratories, Abbott Park, IL, USA). DES was defined as the ELUVIA stent (Boston Scientific, Marlborough, MA, USA) and the ZILVER PTX stent (Cook Corporation, Bloomington, IN, USA). DCBs could enroll all DCBs available in Japan.\u003c/p\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003eStatistical analysis\u003c/h2\u003e\u003cp\u003eData on baseline characteristics are presented as the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD) for continuous variables and the frequency (percentage) for categorical variables, if not otherwise mentioned. \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered significant, and 95% confidence intervals (CIs) were reported as appropriate.\u003c/p\u003e\u003cp\u003eIn this study, we represented the incidence rates of occlusion and restenosis using histograms, while employing probability density functions to visualize the probabilistic distribution of the timing of each event's occurrence. The probability density function does not directly indicate the probability of a specific value itself, but rather represents the probability that data falls within a certain range. For example, the probability that a measurement falls within a specific range can be determined by integrating the value of the probability density function over that range. Additionally, the probability density function is defined such that its integral over all possible values equals 1.\u003c/p\u003e\u003cp\u003eTo flexibly estimate the shape of the probability density function without assuming a prior distribution of the data, we employed Kernel Density Estimation. We executed the kernel density estimation using the \"geom_density()\" function from the R \"ggplot2\" package. The \"geom_density()\" function internally utilizes the \"density()\" function, employing the Gaussian kernel as the kernel function and automatically calculating the bandwidth based on Silverman\u0026rsquo;s Rule of Thumb.\u003c/p\u003e\u003cp\u003eKernel density estimation is utilized in conjunction with histograms to visualize the data distribution more clearly. In particular, it enables a smooth visualization of the distribution that is less affected by the bins of the histogram, allowing for an intuitive understanding of the characteristics of the data.\u003c/p\u003e\u003c/div\u003e"},{"header":"Result","content":"\u003cp\u003eFrom the total of 3635 patients, 699 were in the BNS group, 211 in the CS group, 550 in the DES group, and 1326 in the DCB group. Cases with multiple devices, such as a mixture of DES and CS, were excluded. The baseline patient characteristics of the patients are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Significant differences were found in several parameters, such as more women in the CS group, more Cilostazol administration, and less dyslipidemia. The baseline lesion and procedure characteristics of the patients are shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Lesion length and CTO rates were 140 mm and 49.9% in the BNS group, 250 mm and 69.2% in the CS group, 200 mm and 56.9% in the DES group, and 123 mm and 26.0% in the DCB group. Some parameters, such as cases involving the popliteal artery and vessel diameter, were also indicated significant differences. However, we did not perform propensity match analysis as well as patient background to show the characteristics in real world data.\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\u003eBaseline patient characteristics\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\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=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\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\u003eBNS group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCS group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eDES group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eDCB group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eP value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003en\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e699\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e211\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e550\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1326\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGender\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e533 (76.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e130 (61.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e402 (73.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e923 (69.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e74.9\u0026thinsp;\u0026plusmn;\u0026thinsp;9.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e75.5\u0026thinsp;\u0026plusmn;\u0026thinsp;9.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e74.7\u0026thinsp;\u0026plusmn;\u0026thinsp;9 .0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e73.9\u0026thinsp;\u0026plusmn;\u0026thinsp;9.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.015\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBody mass index (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e22.8\u0026thinsp;\u0026plusmn;\u0026thinsp;4.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e22.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e22.4\u0026thinsp;\u0026plusmn;\u0026thinsp;3.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e22.7\u0026thinsp;\u0026plusmn;\u0026thinsp;4.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.050\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAmbulatory\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e580 (83.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e176 (83.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e467 (84.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1108 (83.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.829\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHypertension\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e570 (81.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e179 (84.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e458 (83.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1094 (82.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.672\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDiabetes mellitus\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e453 (64.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e119 (56.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e356 (64.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e876 (66.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.059\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHyperlipidemia\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e454 (64.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e104 (49.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e353 (64.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e867 (65.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eSmoking (current and past)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e505 (72.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e128 (64.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e406 (73.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e934 (70.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eChronic kidney disease\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\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.004\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eeGFR\u0026thinsp;\u0026lt;\u0026thinsp;60\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e214 (30.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e89 (42.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e216 (39.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e473 (35.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRenal failure on dialysis\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e238 (34.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e57 (27.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e158 (28.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e467 (35.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCAPD\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (0.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1 (0.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2 (0.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e9 (0.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCoronary artery disease\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e349 (49.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e116 (55.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e269 (48.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e665 (50.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.510\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCerebral vascular disease\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e147 (21.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e38 (18.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e123 (22.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e324 (24.4%\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.108\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHeart failure\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e165 (23.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e31 (14.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e120 (21.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e299 (22.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.050\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAtrial fibrillation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e117 (16.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e35 (16.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e88 (16.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e203 (15.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.851\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAspirin\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e554 (79.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e178 (84.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e430 (78.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1013 (76.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.054\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eThienopiridine\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e586 (83.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e183 (86.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e481 (87.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1126 (84.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.292\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCilostazol\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e191 (27.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e107 (50.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e169 (30.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e348 (26.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eAnti-coagulation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e112 (16.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e42 (19.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e84 (15.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e219 (16.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.478\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRutherford classification\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\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCategory 2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e78 (11.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e51 (24.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e59 (10.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e160 (12.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCategory 3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e414 (46.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e101 (47.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e320 (58.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e768 (57.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCategory 4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e67 (9.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e24 (11.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e53 (9.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e117 (8.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCategory 5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e125 (17.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e31 (14.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e105 (19.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e250 (18.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCategory 6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e15 (2.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (1.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e13 (2.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e31 (2.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAnkle brachial index\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.62 [0.50, 0.73]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.60 [0.49, 0.72]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.63[0.50, 0.74]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.67[0.54, 0.80]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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=\"6\"\u003eCategorical variables are expressed as number and percentage. Continuous variables are indicated as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation or median (interquartile range). BNS\u0026thinsp;=\u0026thinsp;bare nitinol stent, CS\u0026thinsp;=\u0026thinsp;covered stent, DCB\u0026thinsp;=\u0026thinsp;drug coated balloon, DES\u0026thinsp;=\u0026thinsp;drug eluting stent, GFR\u0026thinsp;=\u0026thinsp;glomerular filtration rate, CAPD\u0026thinsp;=\u0026thinsp;continuous ambulatory peritoneal dialysis\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\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\u003eBaseline lesion characteristics of study population\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\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=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\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\u003eBNS group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCS group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eDES group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eDCB group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eP value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003en\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e699\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e211\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e550\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1326\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLesion location\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\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eSFA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e539 (77.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e92 (43.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e382 (69.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e775 (58.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePopliteal\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e65 (9.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e12 (5.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e105 (19.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e240 (18.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSFA to popliteal\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e95 (13.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e107 (50.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e147 (26.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e311 (23.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDe novo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e582 (83.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e151 (71.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e468 (85.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e986 (74.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eReference diameter\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5.5 [5.0, 6.0]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5.8 [5.5, 6.0]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e5.5 [5.0, 6.0]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e5.2 [4.7, 5.8]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eLesion length\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e140 [80, 220]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e250 [180, 300]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e200 [100, 260]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e123 [60, 216]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eCTO\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e349 (49.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e146 (69.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e398 (56.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e345 (26.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eCTO length\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e150 [60, 220]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e200 [90, 250]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e190 [90, 250]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e100 [42, 210]\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003ePACSS grade\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\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e230 (32.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e76 (36.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e205 (37.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e551 (41.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e68 (9.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e33 (15.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e66 (12.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e183 (13.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e30 (4.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e12 (5.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e38 (6.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e81 (6.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e103 (14.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e21 (10.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e71 (12.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e179 (13.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e268 (38.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e69 (32.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e170 (30.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e332 (25.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWire crossing\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\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eFluoro\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e565 (80.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e182 (86.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e441 (80.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1195 (90.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEVUS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e36 (5.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e19 (9.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e32 (5.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e38 (2.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIVUS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e98 (14.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10 (4.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e77 (14.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e93 (7.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTreatment device\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\u003ctd align=\"char\" char=\".\" colname=\"c6\"\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\u003eSUPERA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e211 (30.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBNS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e488 (69.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVIABAHN\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e211 (100.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIN.PACT\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e839 (63.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLUTONIX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e465 (35.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRANGER\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e9 (0.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOther DCB\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e13 (1.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eELUVIA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e405 (73.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eZILVER PTX\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e145 (26.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0 (0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBail out stent\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e33 (2.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eComplications\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\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNone\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e677 (96.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e198 (93.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e520 (94.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1307 (98.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBlood transfusion\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (0.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1 (0.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1 (0.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1 (0.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDistal embolization\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (0.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (1.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e7 (1.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e7 (0.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePerforation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (0.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (2.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e11 (2.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e6 (0.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePuncture site trouble\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (1.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (1.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e11 (2.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e5 (0.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"6\"\u003eCategorical variables are expressed as number and percentage. Continuous variables are indicated as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation or median (interquartile range). SFA\u0026thinsp;=\u0026thinsp;superficial femoral artery, CTO\u0026thinsp;=\u0026thinsp;chronic total occlusion, PACSS\u0026thinsp;=\u0026thinsp;Peripheral Arterial Calcium Scoring System, EVUS\u0026thinsp;=\u0026thinsp;extravascular ultrasound, IVUS\u0026thinsp;=\u0026thinsp;intravascular ultrasound, BTK\u0026thinsp;=\u0026thinsp;below the knee\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eKaplan-Meier curves of primary patency divided into reocclusion and restenosis were shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Because of the different lesion backgrounds, simple comparisons cannot be made, but the characteristics of restenosis for each device can be found. To clarify these characteristics, separate graphs were made for reocclusion and restenosis every 3 months (\u003cb\u003eFigure. 2\u003c/b\u003e). Peak restenosis timing was 6\u0026ndash;9 months for BNS and DCB, 12\u0026ndash;15 months for CS and DES. The timing of reocclusion was 6\u0026ndash;9 months for BNS and DES, 3\u0026ndash;6 months for CS, and 0\u0026ndash;3 months for DCB. The DCB group has fewer reocclusion, but a relatively high rate of restenosis is present; the DES and CS groups show a relatively same pattern. Particularly within 6 months, there is more reocclusion than restenosis, with a clear peak in restenosis at around 1 year.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eClinical results were presented in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. CS, DCB, and DES had better freedom from TLR rate than BNS, but only DES was significantly better at 2 years. There were no significant differences in major amputation and mortality between the four groups.\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\u003eClinical outcomes\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=\"left\" 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\u003eBNS group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCS group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eDES group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eDCB group\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e699\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e211\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e550\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1326\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTLR\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\u003e1y event free rate (95%CI). %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.83 (0.80\u0026ndash;0.86)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.85 (0.79\u0026ndash;0.89)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.91 (0.88\u0026ndash;0.94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.89 (0.87\u0026ndash;0.91)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e2y event free rate (95%CI). %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.72 (0.68\u0026ndash;0.76)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.78 (0.70\u0026ndash;0.83)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.79 (0.74\u0026ndash;0.84)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.75 (0.71\u0026ndash;0.78)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHazard ratio (95%CI) vs. BNS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003econtrol\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.72 (0.50\u0026ndash;1.02)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.72 (0.54\u0026ndash;0.96)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.90 (0.72\u0026ndash;1.11)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMajor amputation\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\u003e1y event free rate (95%CI). %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.98 (0.96\u0026ndash;0.99)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1.00 (0.96\u0026ndash;1.00)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.98 (0.96\u0026ndash;0.99)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.98 (0.97\u0026ndash;0.99)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e2y event free rate (95%CI). %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.97 (0.95\u0026ndash;0.98)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.99 (0.94\u0026ndash;1.00)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.97 (0.95\u0026ndash;0.98)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.97 (0.95\u0026ndash;0.98)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHazard ratio (95%CI) vs. BNS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003econtrol\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.36 (0.08\u0026ndash;1.56)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1.04 (0.50\u0026ndash;2.17)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.91 (0.49\u0026ndash;1.68)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAll cause death\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\u003e1y event free rate (95%CI). %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.88 (0.85\u0026ndash;0.90)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.93 (0.88\u0026ndash;0.96)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.90 (0.87\u0026ndash;0.92)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.91 (0.89\u0026ndash;0.92)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e2y event free rate (95%CI). %\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.79 (0.76\u0026ndash;0.83)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.83 (0.76\u0026ndash;0.88)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.81 (0.76\u0026ndash;0.85)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.82 (0.79\u0026ndash;0.85)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHazard ratio (95%CI) vs. BNS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003econtrol\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.85 (0.61\u0026ndash;1.20)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.93 (0.71\u0026ndash;1.22)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.87 (0.70\u0026ndash;1.09)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eTLR\u0026thinsp;=\u0026thinsp;target lesion revascularization, CI\u0026thinsp;=\u0026thinsp;confidence interval\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study examined the performance of various devices in real-world data, categorized by restenosis, reocclusion, and detailed timing. Many studies have already been reported on the results of each device, but there are no reports of detailed data focusing on reocclusion, restenosis, or timing. In general, BNS experiences patency loss in 6 months to 1 year, followed by a slow decline, while DCB is less likely to plateau after 1 year (#7, 21). It is important to note that the DES and CS groups show relatively similar patterns, with patency loss within 6 months being mainly due to reocclusion rather than restenosis.\u003c/p\u003e\u003cp\u003eThe key is to avoid reocclusion rather than restenosis. Since reocculsion is associated with extremity inferior long-term results (#16) before the drug device was available. Even with the availability of drug devices, results for reocclusion have not been satisfactory (#22). In Japan, where there are few debulking devices available, the high rate of complications, including distal embolization, is also a concern (#13). Moreover, reocclusion treatment is likely to increase stent length (#23). It is therefore crucial to avoid reocclusion, and it has been reported that avoiding scaffold placement in small vessels, plaque landings, and up to popliteal lesions is important (#24). Scaffolds are reported to cause more thrombosis than DCBs, and ALI is also reported to increase (17). However, no significant difference in MA rates was found in this study.\u003c/p\u003e\u003cp\u003eAnother method to improve patency is pharmacotherapy. In terms of improving long-term result of EVT, there have been several reports with cilostazol (#25, 26). However, these are mainly limited to Scaffold data, and DCB data are scarce.\u003c/p\u003e\u003cp\u003eIn addition, the efficacy of anticoagulation therapy for PAD has been reported, particularly reducing acute limb ischemia (# 18, 19). In the latest guidelines, anticoagulation is strongly recommended as class of recommendation, Class I, level of evidence, Level A (#27). Thus, anticoagulants have the potential to reduce reocclusion, but DES need a double antiplatelet therapy (DAPT) period of more than 2 months and CS more than 6 months. The problem is that long term period of triple antithrombotic agents. Sub-analysis suggest that DAPT plus anticoagulation for more than 30 days is associated with increased bleeding complications (#20). LEAD patients are often high bleeding risk, and concerns remain about long-term antithrombotic drug administration (#28). Anticoagulation only during periods of high reocclusion with Scaffold implantation might lead to improved outcomes. Hence, it is extremely important to know when reocclusion are most common for each device.\u003c/p\u003e\u003cp\u003eIn this study, devices were divided into four categories. Although there are reports that SUPERA stent have different patency rates than regular BNS and that ZILVER PTX and ELUVIA have different reocclusion rates (#21, 29). However, too detailed a classification could undermine the essence of this study, so four classifications were used.\u003c/p\u003e\u003cp\u003eDCB was the most used in the study, with 1326 cases. Despite having the shortest lesion length as well as the fewest CTOs, primary patency is not the best. The fact that DCB is the most used despite low patency in easy lesions may indicate that reocclusion avoidance is a strong factor in device selection. The key point about patency loss in DCB is that reocclusions were most common in the early stages of treatment. This is most likely not an effect of the drug failure, but a so-called balloon failure. Confirmation of minimal lesion area with intravascular ultrasound, correct evaluation of dissection and bail out stenting may contribute to improved DCB outcomes (#30).\u003c/p\u003e\n\u003ch3\u003eLimitations\u003c/h3\u003e\n\u003cp\u003eThis study has several limitations. First, this study had a multicenter, retrospective, and non-randomized design, causing potential bias. Second, propensity match was not performed, there is variation in patient and lesion backgrounds. Third, the exact duration of drug administration remains unknown and the data are from a period when low-dose rivaroxaban was not available. Fourth, data from multiple devices, such as DCB and DES combination, was excluded. Lastly, clinical follow-ups were performed at each institute; however, no follow-up protocol was established during the study period.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eNot only were the primary patency for each device different, but the timing of restenosis and reocclusion for each device was also different. In order to improve device performance, it will be necessary to understand the timing of restenosis and reocclusion.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cem\u003eEthics approval and consent to participate\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the local ethics committee of each participating center, and the study was performed in accordance with the Declaration of Helsinki. The requirement for informed consent was waived because of the retrospective study design and public health exception. Relevant information regarding the research will be disclosed in accordance with the Ethical Guidelines for Medical and Medical Technology Research Involving Human Subjects.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eFor this type of study consent for publication is not required.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAvailability of data and material\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study are available from the corresponding author upon reasonable request. The data are not publicly available due to privacy or ethical restrictions.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFunding\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConflict of interest\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eKS\u0026nbsp;received remuneration for lecture from Cordis and KANEKA Medix. KT is a consultant of Gore and Boston Scientific, and received honorarium from Gore, Medtronic, Boston Scientific, Kaneka Medics, TERUMO and Becton, Dickinson and Company. NH is a consultant of Reflow medical, and received honoraria from Terumo, Kaneka Medix, Medicos Hirata, Boston Scientific, Medtronic, Cordis, Abbot Vascular and Becton, Dickinson and Company. SM received lecture fee from Becton, Dickinson and Company, and Terumo. TN is a consultant of Becton, Dickinson and Company, Boston Scientific, Century Medical Inc., COOK Medical, Cordis, Kaneka Medix, Asahi Intecc, NIPRO, and OrbusNeich and received lecture fee from Abbot Vascular, Terumo and Medtronic. The other author reports no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthor contribution\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eKS, DU, KT, NH, SM, YI, KH, and TN contributed to the study concept and design; KS, KT, NH, NH, SM, YI, KH, and TN contributed to data collection, KS and DU contributed to data analysis.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthor contribution\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eAboyans V, Ricco JB Bartelink ML, Bjork M, Brodmann M, Cohnert T, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries Eur Heart J 2018;39:763-816\u003c/li\u003e\n\u003cli\u003eLaird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, et al; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012; 19: 1-9\u003c/li\u003e\n\u003cli\u003eKarashima E, Takahara M, Hozawa K, Yamauchi Y, Suzuki K, Suematsu N, et al. Three-Year Clinical Outcomes of the Innova Self-Expanding Nitinol Stent for the Treatment of Femoropopliteal Lesions Cardiovasc Intervent Radiol 2021, 44: 1722-1727\u003c/li\u003e\n\u003cli\u003eTepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, et al. Local Delivery of Paclitaxel to Inhibit Restenosis during Angioplasty of the Leg N Engl J Med 2008;358:689-99 \u003c/li\u003e\n\u003cli\u003eTepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial Circulation. 2015;131:495-502\u003c/li\u003e\n\u003cli\u003eRosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtrado C, Metzger C, et al Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease N Engl J Med 2015; 373: 145-153\u003c/li\u003e\n\u003cli\u003eDake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. \u003cem\u003eCirc Cardiovasc Interv\u003c/em\u003e. 2011;4:495\u0026ndash;504.\u003c/li\u003e\n\u003cli\u003eDake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery 5-Year Results of the Zilver PTX Randomized Trial Circulation 2016; 133:1472-1438\u003c/li\u003e\n\u003cli\u003eLammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, Mueller-Huelsbeck S, et al. Heparin-Bonded Covered Stents Versus Bare-Metal Stents for Complex Femoropopliteal Artery Lesions J Am Coll Cardiol 2013;62:1320-7\u003c/li\u003e\n\u003cli\u003eSoga Y, Takahara M, Iida O, Tomi Y, Kawasaki D, Tanaka A, et al. Vessel Patency and Associated Factors of Drug-Coated Balloon for Femoropopliteal Lesion J Am Heart Assoc 2023;12:e025677\u003c/li\u003e\n\u003cli\u003eIida O, Takahara M, Soga Y, Yamaoka T, Fujihara M, Kawasaki D, et al. 1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration JACC Cardiovasc interv 2022;15:630-638\u003c/li\u003e\n\u003cli\u003eIida O, Ohki T, Soga Y, Suematsu N, Nakama T, Yamaoka T, et al Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study Vasc Med 2024;29:416-423\u003c/li\u003e\n\u003cli\u003eIchihashi S, Takahara M, Iida O, Suzuki K, Yamaoka T, Maeda K, Clinical Impact of Stent Graft Thrombosis in Femoropopliteal Arterial Lesions J Am Coll Cardiol Intv 2021;14:1137\u0026ndash;47\u003c/li\u003e\n\u003cli\u003eVirga V, Stabile E, Biamino G, Salemme G, Cioppa A, Giugliano G, et al. Drug-Eluting Balloons for the Treatmentbof the Superficial Femoral Artery In-Stent Restenosis J Am Coll Cardiol Intv 2014;7:411\u0026ndash;5\u003c/li\u003e\n\u003cli\u003eHorie K, Tanaka A, Suzuki K, Taguri M, Inoue N. Long-term clinical effectiveness of a drug-coated balloon for in-stent restenosis in Femoropopliteal lesions CVIR Endovasc. 2021;4:13\u003c/li\u003e\n\u003cli\u003eTosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, et al Classification and Clinical Impact of Restenosis After Femoropopliteal Stenting J Am Coll Cardiol 2012;59:16-23\u003c/li\u003e\n\u003cli\u003eNakano S, Iida O, Takahara M, Okamoto S, Ishihara T, Tsujimura T, et al. Incidence of Acute Thrombotic Occlusion and Its Predictors After Contemporary Femoropopliteal Endovascular Therapy in Patients With Peripheral Artery Disease J Endovasc Ther 2024;31:263-273\u003c/li\u003e\n\u003cli\u003eBonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, et al Rivaroxaban in Peripheral Artery Disease after Revascularization N Engl J med 2020;382:1994-200\u003c/li\u003e\n\u003cli\u003eHess CN, Debus ES, Nehler MR Anand SS, Patel MR, Szarek M, et al. Reduction in Acute Limb Ischemia With Rivaroxaban Versus Placebo in Peripheral Artery Disease After Lower Extremity Revascularization; Insight From VOYAGER PAD, Circulation 2021;144:1831-1841\u003c/li\u003e\n\u003cli\u003eHiatt WR, Bonaca MP, Patel MR Nehler MR, Debus ES, Anand SS, et al. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety Circulation 2020;142:2219-2230\u003c/li\u003e\n\u003cli\u003eSteiner S, Schmidt A, Bausback Y, Piorkowski M, Werner M, Yahiaoui-Doktor M, et al. Midterm Patency After Femoropopliteal Interventions: A Comparison of Standard and Interwoven Nitinol Stents and Drug-Coated Balloons in a Single-Center, Propensity Score\u0026ndash;Matched Analysis J Endovasc Ther 2016;23:347-355\u003c/li\u003e\n\u003cli\u003eSuzuki K, Takahara M, Tobita K, Hayakawa N, Mori S, Iwata Y, et al, Contemporary Therapy of Femoropopliteal In-Stent Restenosis / Occlusion, 36-month Follow up Study Vasc Endovascular Surg 2024;58:693-700\u003c/li\u003e\n\u003cli\u003eNagatomi S, Takahara M, Nakai T, Fujimura N, Yu A, Masuda D, et al. Comparing the impact of the loss of patency between treatment with drug-coated balloon angioplasty and drug-eluting stent placement J Vasc Surg 2023;77:1751-1759\u003c/li\u003e\n\u003cli\u003eKurata N, Iida O, Takahara M, Asai M, Okamoto S, Ishihara T, et al. Comparing Predictors Influencing Restenosis Following High-Dose Drug-Coated Balloon Angioplasty and Fluoropolymer-Based Drug-Eluting Stenting in Femoropopliteal Artery Lesions J Endovasc Ther 2025; 32: 1194-1204\u003c/li\u003e\n\u003cli\u003eIida O, Yokoi H, Soga Y, Inoue N, Suzuki K, Yokoi Y, et al. Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study Circulation 2013;127:2307-15\u003c/li\u003e\n\u003cli\u003eTobita K, Takahara M, Iida O, Soga Y, Yamaoka T, Ichihashi S, et al. Clinical Impact of Additional Cilostazol Treatment on Restenosis Risk following Heparin-Bonded Stent Graft Implantation: Sub-Analysis from the Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study J Atheroscler Thromb 2023;30:1461-1470\u003c/li\u003e\n\u003cli\u003e2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, et al J Am Coll Cardiol 2024;83:2497-2604\u003c/li\u003e\n\u003cli\u003eSpirito A, Cohen R, Sartori S, Vogel B, Baber U, Pileggi B, et al. Prognostic impact of peripheral artery disease in patients with and without high bleeding risk undergoing percutaneous coronary intervention Catheter Cardiovasc Interv 2024;103:425-434\u003c/li\u003e\n\u003cli\u003eShibata T, Iba Y, Shingaki M, Yamashita O, Tsubakimoto Y, Kimura F, et al. One Year Outcomes of Zilver PTX Versus Eluvia for Femoropopliteal Disease in Real-World Practice: REALDES Study J Endovasc Ther 2023 Jun 8:15266028231179861\u003c/li\u003e\n\u003cli\u003eKodama T, Kuwabara M, Ueshima D, Yamaguchi T, Fujimoto Y, Miyazaki T, et al. Impact of intravascular ultrasound on limb events in endovascular therapy for patients with peripheral arterial disease: insights from the TOMA-CODE registry Cardiovasc Interv and Ther 2025; 40: 344-351\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"cvir-endovascular","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"cire","sideBox":"Learn more about [CVIR Endovascular](https://www.springer.com/journal/42155)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/cire/default.aspx","title":"CVIR Endovascular","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Peripheral arterial disease, restenosis, reocclusion","lastPublishedDoi":"10.21203/rs.3.rs-7751607/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7751607/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Drug-eluting device and covered stent have become the mainstream of endovascular therapy for femoropopliteal lesions. Though there have been many reports on the primary patency of each device, there are few detailed data on restenosis and reocclusion. This was a physician-initiated, multicenter, retrospective study. From 7 institutes, 3635 femoropopliteal cases were enrolled in this study. Among them, we studied 2786 cases treated with drug-eluting stent (DES), drug-coated balloon (DCB),\u003c/p\u003e\n\u003cp\u003ecovered stent (CS), and bare nitinol stent (BNS).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eResults\u003c/em\u003e: The lesion background for each device was different, with mean lesion lengths of 140 (80-220) mm for BNS, 250 (180-300) mm for CS, 200 (100-260) mm for DES, and 123 (60-216) mm for DCB (P\u0026lt;0.001). Primary patency at 2 years was 62% for BNS, 75% for CS, 74% for DES, and 65% for DCB. Timing of restenosis and reocclusion were also different for each device. Peak restenosis timing was 6-9 months for BNS and DCB, 12-15 months for CS and DES. The timing of reocclusion was 6-9 months for BNS and DES, 3-6 months for CS, and 0-3 months for DCB.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConclusions\u003c/em\u003e: Not only were the primary patency for each device different, but the timing of restenosis and reocclusion for each device was also different.\u003c/p\u003e","manuscriptTitle":"Detailed timing of reocclusion and restenosis in endovascular therapy of the femoropopliteal lesions","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-10 05:27:47","doi":"10.21203/rs.3.rs-7751607/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-11-03T03:36:17+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-28T11:11:15+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-28T06:22:16+00:00","index":"","fulltext":""},{"type":"submitted","content":"CVIR Endovascular","date":"2025-10-24T06:04:27+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"cvir-endovascular","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"cire","sideBox":"Learn more about [CVIR Endovascular](https://www.springer.com/journal/42155)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/cire/default.aspx","title":"CVIR Endovascular","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"0cf3f4b8-d9a7-41be-b36a-4b8ca3a882a3","owner":[],"postedDate":"November 10th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-11-10T05:27:47+00:00","versionOfRecord":[],"versionCreatedAt":"2025-11-10 05:27:47","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7751607","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7751607","identity":"rs-7751607","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}