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Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

Background: Although the 1-year clinical outcomes of fluoropolymer-based drug-eluting stents (FP-DES) were favorable for the treatment of real-world femoropopliteal lesions in symptomatic peripheral artery disease (PAD), their performance beyond 1 year remained unknown. The current study determined the 3-year clinical course of FP-DES implantation for real-world femoropopliteal lesions., Methods: This multicenter, prospective, observational study evaluated 1204 limbs (chronic limb-threatening ischemia, 34.8%; mean lesion length, 18.6 ± 9.9 cm, chronic total occlusion: 53.2%) of 1097 patients with PAD (age, 75 ± 9 years; diabetes mellitus, 60.8%) undergoing FP-DES implantation for femoropopliteal lesions. The primary outcome measure was 3-year restenosis. The secondary outcome measures included 3-year occlusive restenosis, stent thrombosis, target lesion revascularization (TLR), and aneurysmal degeneration., Results: The 3-year cumulative occurrence of restenosis was 27.3%, whereas that of occlusive restenosis, stent thrombosis, and TLR was 16.1%, 7.3%, and 19.6%, respectively. The annual occurrence of restenosis decreased by 12.0%, 9.5%, and 5.8% in the first, second, and third year, respectively ( p < 0.001). Similarly, the rates of occlusive restenosis and stent thrombosis decreased ( p < 0.001 and p = 0.007, respectively), whereas the rate of TLR remained unchanged for 3 years ( p = 0.15). The incidence of aneurysmal degeneration at 3 years (15.7%) did not significantly differ from that at 1 and 2 years ( p = 0.69 and 0.20, respectively)., Conclusions: This study highlights the favorable long-term clinical course of FP-DES in real-world practice, emphasizing the importance of monitoring for occlusive restenosis and stent thrombosis while considering the potential onset of aneurysmal degeneration., Competing Interests: Declaration of conflicting interestsDrs Iida and Soga are consultants who received honoraria from Boston Scientific. Drs Yamaoka, Fujihara, Kawasaki, and Ichihashi received remuneration from Boston Scientific Japan KK. Dr Mano received a research grant from Abbott Vascular Japan. Dr Sakata received an honorarium from Otsuka Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Medtronic Japan, and Boehringer Ingelheim Japan; a research grant from Edwards Lifesciences, FUJIFILM RI Pharma, REGiMMUNE, and Roche Diagnostics; and a scholarship (educational) grant/endowed chair from Otsuka Pharmaceutical, Johnson & Johnson, St Jude Medical Japan, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Teijin Pharma Limited, Boehringer Ingelheim Japan, Bayer Yakuhin, BIOTRONIK Japan, Boston Scientific, and Medtronic Japan. The remaining authors have no conflicts of interest to declare.

Background: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited., Methods: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%., Results: A total of 201 patients were enrolled and randomly assigned to treatment ( N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (P superiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (P noninferiority = 0.0433)., Conclusion: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496) ., Competing Interests: Declaration of conflicting interestsHans van Overhagen, MD, PhD, serves as a consultant for Boston Scientific and Cordis. Masato Nakamura, MD, PhD, serves as a consultant for Terumo Co. and Boston Scientific; has received honoraria from Boston Scientific and Terumo Co. Patrick J Geraghty, MD, holds stock or stock options in MedAlliance SA, Aveera, Protexa, and Pulse Therapeutics. Sid Rao, MD, serves as a consultant for Cardiovascular Systems, Inc. and Philips. Max Arroyo, MD, has no conflicts of interest to declare. Yoshimitsu Soga, MD, serves as an advisor to Boston Scientific. Osamu Iida, MD, serves as a consultant for Boston Scientific. Ehrin Armstrong, MD, serves as a consultant for Abbott Vascular, Boston Scientific, Gore, Medtronic, Philips, and Shockwave Medical. Tatsuya Nakama, MD, serves as a consultant for Boston Scientific, BD, Cook Medical, Cordis, Kaneka, NIPRO, and OrbusNeichi. Masahiko Fujihara, MD, serves as a consultant for Boston Scientific. Mohammad M Ansari, MD, serves as an advisory board member for Boston Scientific, Medtronic, and Cordis; a steering committee member for Philips; a consultant for Boston Scientific, Terumo, Edwards, Gore, Abbott, Bard, and Medtronic; has research trials with Boston Scientific, Terumo, Gore, Abbott, and Reflow Medical. Santhosh J Mathews, MD, MS, serves as a consultant and advisory board member for Philips, Boston Scientific, Abbott Vascular, and Reflow Medical; a consultant for Penumbra, Cordis, and Shockwave. Yann Gouëffic, MD, PhD, has received research funding from Abbott, Boston Scientific, General Electric, Veryan, WL Gore, and personal fees and grants from Abbott, Bard, Biotronik, Boston Scientific, Cook, General Electric, Medtronic, Penumbra, Terumo, Veryan, and WL Gore. Michael R Jaff, DO, is an employee of Boston Scientific, is a board member of Access Vascular; serves as a consultant for Gilde Healthcare; has an equity investment in R3 Vascular and EFemoral. Ido Weinberg, MD, serves as a consultant to Magneto Thrombectomy Solutions and Penumbra, Inc.; is an employee of VasCore. Duane S Pinto, MD, MPH, serves as a consultant to Abbott Vascular, Abiomed, Biotronik, Boston Scientific, Magenta Medical, Medtronic, NuPulseCV, Terumo; has employment with JenaValve Technology. Norihiko Ohura, MD, serves as a consultant for Boston Scientific. Kara Couch, MS, CRNP, CWCN-AP, FAAWC, serves as a consultant for Boston Scientific and vTail; is on the speaker’s bureau for 3M, Urgo Medical North America, and Organogenesis, Inc. Jihad A Mustapha, MD, serves as a consultant to Angiodynamics, BD Bard, Cardiovascular Systems, Inc., Medtronic, Philips; a consultant and researcher for Avinger, Boston Scientific, Endologix, and Terumo; is Chief Medical Officer for Micromedical; has equity ownership and is a researcher and board member of CardioFlow; has equity ownership of Iatri; is a researcher and has stock options in Reflow Medical.

Introduction: Although favorable results of fluoropolymer-based drug-eluting stent (FP-DES) treatment for femoropopliteal lesions have been reported, it is unclear whether minimal lumen area (MLA) after FP-DES implantation affects clinical outcomes. This study aimed to reveal the association between intravascular ultrasound (IVUS)-evaluated MLA and the 1-year risk of restenosis and aneurysmal degeneration after FP-DES implantation for femoropopliteal lesions., Methods: A subanalysis of the CAPSICUM (Contemporary outcomes After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsChemia with sUperficial feMoral or proximal popliteal lesion) study analyzed 718 limbs in 686 patients with available IVUS-evaluated MLA data. The association of MLA with the 1-year risk of restenosis and aneurysmal degeneration was analyzed using the generalized propensity score method., Results: The 1-year incidence rate of restenosis was estimated to be 8.8% (95% CI, 6.1% to 12.5%) for the upper quartile of MLA (21.1 mm 2 ) versus 14.3% (95% CI, 10.7% to 18.7%) for the lower quartile of MLA (15.2 mm 2 ), with an odds ratio of 0.58 (95% CI, 0.36 to 0.93; p = 0.024), whereas the 1-year incidence rate of aneurysmal degeneration was 23.8% (95% CI, 19.5% to 28.8%) for the upper quartile versus 16.8% (95% CI, 12.6% to 22.0%) for the lower quartile, with an odds ratio of 1.55 (95% CI, 1.04 to 2.32; p = 0.031)., Conclusion: A large MLA after FP-DES implantation for femoropopliteal lesions was associated with decreased restenosis risk but increased aneurysmal degeneration risk. These findings suggest that MLA is a valuable predictor of clinical outcomes., Competing Interests: Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Osamu Iida and Yoshimitsu Soga are consultants who received honoraria from Boston Scientific. Terutoshi Yamaoka, Masahiko Fujihara, Daizo Kawasaki, Shigeo Ichihashi, and Amane Kozuki received remuneration from Boston Scientific Japan. The remaining authors have no conflicts of interest to report.

Aims: There is a scarcity of studies comparing percutaneous coronary intervention (PCI) using new-generation drug-eluting stents (DES) with coronary artery bypass grafting (CABG) in patients with multi-vessel coronary artery disease., Methods and Results: The CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients who underwent first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013. The current study population consisted of 2464 patients who underwent multi-vessel coronary revascularization including revascularization of left anterior descending coronary artery (LAD) either with PCI using new-generation DES (N = 1565), or with CABG (N = 899). Patients in the PCI group were older and more often had severe frailty, but had less complex coronary anatomy, and less complete revascularization than those in the CABG group. Cumulative 5-year incidence of a composite of all-cause death, myocardial infarction or stroke was not significantly different between the 2 groups (25.0% versus 21.5%, P = 0.15). However, after adjusting confounders, the excess risk of PCI relative to CABG turned to be significant for the composite endpoint (HR 1.27, 95%CI 1.04-1.55, P = 0.02). PCI as compared with CABG was associated with comparable adjusted risk for all-cause death (HR 1.22, 95%CI 0.96-1.55, P = 0.11), and stroke (HR 1.17, 95%CI 0.79-1.73, P = 0.44), but with excess adjusted risk for myocardial infarction (HR 1.58, 95%CI 1.05-2.39, P = 0.03), and any coronary revascularization (HR 2.66, 95%CI 2.06-3.43, P<0.0001)., Conclusions: In this observational study, PCI with new-generation DES as compared with CABG was associated with excess long-term risk for major cardiovascular events in patients who underwent multi-vessel coronary revascularization including LAD., Competing Interests: The authors have declared that no competing interests exist.

Purpose: To explore the clinical features associated with stent eccentricity and reveal the impact of stent eccentricity on the risk of 1-year restenosis after femoropopliteal stent implantation for symptomatic atherosclerotic peripheral artery disease (PAD)., Materials and Methods: The clinical database of a multicenter prospective study was used. It registered 2,018 limbs of 1,766 patients in whom intravascular ultrasound (IVUS)-supported femoropopliteal endovascular therapy (EVT) for symptomatic atherosclerotic PAD was planned from November 2015 to June 2017. The study included 1,233 limbs of 1,088 patients implanted with a bare nitinol stent, drug-eluting stent (DES), or stent graft and administered ≥2 antithrombotic drugs. The stent eccentricity was evaluated using IVUS, calculated as [(maximum diameter) / (minimum diameter) - 1] at the cross-sectional segment with the lowest lumen area after stent implantation., Results: Chronic total occlusion and bilateral arterial calcification (peripheral artery calcification scoring system Grades 3 and 4) were positively associated with stent eccentricity, whereas renal failure while receiving dialysis, DES use, and stent graft use were negatively associated with stent eccentricity (all P < .05). Stent eccentricity was associated with an increased risk of 1-year restenosis (odds ratio [OR], 1.18; 95% CI, 1.01-1.37; P = .034). However, after adjustment for lesion severity and implanted stent types, the association was no longer significant (OR, 1.07; 95% CI, 0.91-1.24; P = .43)., Conclusions: Stent eccentricity was not significantly associated with the risk of 1-year restenosis after femoropopliteal EVT., (Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved.)

Background: Treatment with a fluoropolymer-based drug-eluting stent (FP-DES has been widely applied to the contemporary femoropopliteal practice with durable outcomes. Nevertheless, the impact of intravascular ultrasound (IVUS) utilization on clinical outcomes after FP-DES implantation has not been determined., Objectives: This study aimed to investigate the impact of IVUS on 1-year clinical outcomes after FP-DES) implantation for femoropopliteal lesions in patients with symptomatic peripheral artery disease., Methods: As a subanalysis of the CAPSICUM (contemporary outcomes after paclitaxel-eluting peripheral stent implantation for symptomatic lower limb ischemia with superficial femoral or proximal popliteal lesion) study, the present investigation analyzed 1,091 patients with symptomatic peripheral artery disease who underwent endovascular therapy with FP-DES for femoropopliteal lesions. One-year clinical outcomes were compared between patients treated with IVUS and those treated without IVUS after propensity score matching. The primary outcome measure was 1-year restenosis. The incidence of aneurysmal degeneration was also assessed., Results: A total of 843 (77.2%) patients underwent IVUS-guided FP-DES implantation. After propensity score matching, the 1-year restenosis was not significantly different between the groups (11.5% [95% CI: 9.1%-14.0%] vs 15.5% [95% CI: 10.9%-20.1%]; P = 0.22). The frequency of aneurysmal degeneration at 1 year was significantly higher in the IVUS group than in the non-IVUS group (19.8% [95% CI: 16.3%-23.4%] vs 7.1% [95% CI: 3.3%-11.0%]; P < 0.001). IVUS use was associated with a lower restenosis risk in patients with chronic total occlusion but not in those without (P for interaction = 0.044)., Conclusions: The present study revealed that 1-year restenosis risk was not significantly different between the 2 groups, whereas the incidence of aneurysmal degeneration was significantly higher in the IVUS group., Competing Interests: Funding Support and Author Disclosures The CAPSICUM study was supported by the Research Association for Lower Limb Artery Revascularization (LIBERAL) and sponsored by the following companies (in alphabetical order): Boston Scientific Japan K.K., OrbusNeich Foundation, Terumo Corp., and Kaneka Medix Corporation. The funding companies played no role in the design of the study, selection of the enrolled patients, treatment strategy, revascularization procedures or equipment, or in the collection, analysis, and interpretation of the data. Drs Iida and Soga have received consulting honoraria from Boston Scientific. Drs Yamaoka, Fujihara, Kawasaki, Ichihashi, and Kozuki have received remuneration from Boston Scientific Japan K.K. Dr Sakata received honoraria from Otsuka Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Medtronic Japan, and Boehringer Ingelheim Japan; a research grant from Edwards Lifesciences, FUJIFILM RI Pharma, REGiMMUNE, and Roche Diagnostics; and a scholarship (educational) grant/endowed chair from Otsuka Pharmaceutical, Johnson & Johnson, St. Jude Medical Japan, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Teijin Pharma Limited, Boehringer Ingelheim Japan, Bayer Yakuhin, BIOTRONIK Japan, Boston Scientific, and Medtronic Japan. Dr Mano has received a research grant from Abbott Vascular Japan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to investigate the 1-year risk of restenosis and aneurysmal degeneration and explore the associated factors after femoropopliteal implantation of fluoropolymer-based drug-eluting stents (FP-DESs) for symptomatic atherosclerotic peripheral artery disease in real-world practice., Background: Although clinical trials have demonstrated that FP-DES implantation has favorable 1-year outcomes, its performance in real-world practice has not been well elucidated., Methods: This multicenter, prospective, observational study evaluated 1,204 limbs (chronic limb-threatening ischemia: 34.8%, mean lesion length: 18.6 ± 9.9 cm, chronic total occlusion: 53.2%, bilateral wall calcification: 41.9%) of 1,097 patients with peripheral artery disease (age: 75 ± 9 years, men: 69.4%, diabetes mellitus: 60.8%, chronic kidney disease: 66.2%) undergoing Eluvia (Boston Scientific) drug-eluting stent implantation for femoropopliteal lesions. The primary outcome measure was 1-year restenosis, whereas the secondary outcome measures were 1-year occlusive restenosis, stent thrombosis, target lesion revascularization, and aneurysmal degeneration., Results: The 1-year occurrence rates of restenosis (12.9%), occlusive restenosis (9.2%), stent thrombosis (3.3%), target lesion revascularization (6.2%), and aneurysmal degeneration (16.8%) were found. Multivariate analysis demonstrated that dialysis, chronic limb-threatening ischemia, history of revascularization, a smaller reference vessel diameter, chronic total occlusion, and spot stenting were significantly associated with an increased risk of 1-year restenosis, whereas intravascular ultrasound use and subintimal wire passage were significantly associated with an increased risk of 1-year aneurysmal degeneration., Conclusions: This study documented the 1-year clinical outcomes after femoropopliteal endovascular therapy with FP-DES implantation in real-world practice. The 1-year restenosis rate would be clinically acceptable, whereas the occurrence of occlusive restenosis and aneurysmal degeneration should be noted., Competing Interests: Funding Support and Author Disclosures The CAPSICUM study was supported by the Research Association for Lower Limb Artery Revascularization (LIBERAL) sponsored by the following companies: Boston Scientific Japan K.K., OrbusNeich Foundation, Terumo Corp., and Kaneka Medix Corporation. The funding companies played no role in the design of the study; selection of the enrolled patients; treatment strategy; revascularization procedures or equipment; or collection, analysis, or interpretation of the data. Drs Iida and Soga are consultants who received honoraria from Boston Scientific. Drs Yamaoka, Fujihara, Kawasaki, Ichihashi, and Kozuki have received remuneration from Boston Scientific Japan K.K. Dr Mano received a research grant from Abbott Vascular Japan. Dr Sakata has received honoraria from Otsuka Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Medtronic Japan, and Boehringer Ingelheim Japan; a research grant from Edwards Lifesciences, FUJIFILM RI Pharma, REGiMMUNE, and Roche Diagnostics; and a scholarship (educational) grant/endowed chair from Otsuka Pharmaceutical, Johnson & Johnson, St. Jude Medical Japan, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi Tanabe Pharma, Teijin Pharma Limited, Boehringer Ingelheim Japan, Bayer Yakuhin, BIOTRONIK Japan, Boston Scientific, and Medtronic Japan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Limited data are available regarding the vascular response after fluoropolymer paclitaxel-eluting stent (FP-PES) implantation. This study sought to assess the vascular response at 6 and 12 months after FP-PES implantation for femoropopliteal artery lesions using serial optical coherence tomography (OCT) examination., Methods and results: From the IMPERIAL trial, this study evaluated 10 de novo femoropopliteal lesions treated with FP-PES. The primary study endpoint was neointimal tissue coverage at a 6- and 12-month follow up, as assessed by serial OCT examination. The incidence of peri-strut low-intensity area (PLIA) and extra-stent lumen (ESL) was also assessed. A total of 203 matched cross-sectional images were evaluated at 6 and 12 months (5,615 and 5,763 struts, respectively). From 6 to 12 months, the mean neointimal thickness tended to increase from 198 µm to 233 µm, with a significant reduction in the incidence of malapposed struts (0.59% vs. 0.28%, P=0.039). Conversely, uncovered struts and PLIA were more frequently observed at 12 months (4.4% vs. 7.8%, P=0.01; 12.7% vs. 21.0%, P<0.001, respectively). The ESL area significantly increased over time without any difference in its incidence (0.24±0.32 mm 2 vs. 0.38±0.36 mm 2 , P=0.009)., Conclusions: Neointimal proliferation was markedly inhibited from 6 to 12 months after FP-PES implantation, whereas the incidence of uncovered struts and PLIA significantly increased over time with the enlargement of ESL.

Purpose: The purpose of the study is to report 24-month efficacy and safety results for the Japanese patient cohort in a prospective randomized controlled trial (RCT) of drug-eluting stent (DES) use for peripheral artery disease., Materials and Methods: Patients in the global IMPERIAL RCT had femoropopliteal lesions treated with either the Eluvia DES (Boston Scientific, Marlborough, MA, USA) or the Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA). At 24 months, assessments included duplex ultrasound imaging for core laboratory vessel patency measurement, target lesion revascularization (TLR) rates, and clinical outcome measures., Results: The Japanese cohort included 84 patients (56 treated with Eluvia and 28 with Zilver PTX). The clinically driven TLR rates were 5.6% (3/54) and 18.5% (5/27) for patients treated with Eluvia and Zilver PTX, respectively (difference -13.0%, 95%CI -28.8, 2.9%; p = 0.11). The Kaplan-Meier estimates for freedom from clinically driven TLR at 24 months were 94.3% for patients who received Eluvia and 80.4% for those who received Zilver PTX (log rank p = 0.05), and for primary patency they were 88.5% and 80.4%, respectively (log rank p = 0.28). Mortality rates were 5.6% (3/54) and 11.1% (3/27); p = 0.39. Rutherford classification improved by at least one category without TLR for 91.8% (45/49) and 68.2% (15/22) of patients (p = 0.03). Walking impairment score improvements were sustained over time., Conclusion: The results at 24 months support the efficacy and safety of DES in Japanese patients, with sustained clinical improvements and numerically fewer reinterventions for those treated with Eluvia., Clinical Trial Registration: Clinicaltrials.gov identifier NCT02574481. https://clinicaltrials.gov/ct2/show/NCT02574481 LEVEL OF EVIDENCE: EBM Level III; cohort analysis of randomized trial., (© 2021. The Author(s).)

Objective: Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings., Methods: This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis., Results: In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034)., Conclusions: Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

The optimal revascularization for in-stent occlusion (ISO) lesions after femoropopliteal (FP) bare-nitinol stenting has not been established. We, therefore, investigated the comparison between drug-coated stent (DCS) implantation and bypass surgery (BSX) for ISO lesions after FP bare-nitinol stenting. This study was a dual-center, observational study from January 2004 to December 2015. A total of 172 ISO lesions were observed, and after excluding 120 ISO lesions, 52 ISO lesions (50 patients; mean age, 71.0 ± 9.2 years; male, 59.6%) after FP bare-nitinol stenting were enrolled. The included patients with clinical symptoms underwent either DCS implantation (n = 28) or BSX (n = 22). The primary endpoint was recurrent in-stent restenosis (ReISR); secondary endpoints were recurrent target lesion revascularization (ReTLR), recurrent occlusion (reocclusion) and major adverse limb events (MALE), and perioperative complications (POCs), respectively. ReISR or reocclusion was defined as ISR or occlusion after TLR. Stent restenosis was defined as a peak systolic velocity ratio (PSVR) > 2.4 on a duplex scan or ≥ 50% stenosis on angiography. Graft restenosis was defined as a PSV > 300 cm/s and velocity ratio 3.5 or uniformly low PSV < 45 cm/s throughout the entire graft based on graft surveillance. The mean follow-up period was 36.6 ± 25.5 months. At 2 years, the rates of freedom from ReISR, ReTLR, and MALE were not significantly different between the DCS implantation and BSX groups (68.9% vs. 73.7%, p = 0.81; 84.7% vs. 73.7%, p = 0.45; 84.7% vs. 78.6%, p = 0.60, respectively). However, the freedom from reocclusion rate was significantly lower in the DCS implantation group (81.6% vs. 100%, p = 0.04). The occurrence of POCs was not significantly different between the DCS implantation and BSX groups (7.1% vs 4.2%, p = 1.0). Although BSX was the gold-standard therapy for ISO lesions after FP bare-nitinol stenting, DCS implantation might be a good option because the rates of freedom from ReISR, ReTLR, and MALE were similar.

Long-term safety of percutaneous coronary intervention (PCI) as compared with coronary artery bypass grafting (CABG) is still controversial in patients with unprotected left main coronary artery disease (ULMCAD), and there is a scarcity of real-world data on the comparative long-term clinical outcomes between PCI and CABG for ULMCAD in new-generation drug-eluting stents era. The CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients undergoing first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013, and we identified 855 patients with ULMCAD (PCI: N = 383 [45%], and CABG: N = 472 [55%]). The primary outcome measure was all-cause death. Median follow-up duration was 5.5 (interquartile range: 3.9 to 6.6) years. The cumulative 5-year incidence of all-cause death was not significantly different between the PCI and CABG groups (21.9% vs 17.6%, Log-rank p = 0.13). After adjusting confounders, the excess risk of PCI relative to CABG remained insignificant for all-cause death (HR, 1.00; 95% CI, 0.68 to 1.47; p = 0.99). There were significant excess risks of PCI relative to CABG for myocardial infarction and any coronary revascularization (HR, 2.07; 95% CI, 1.30 to 3.37; p = 0.002, and HR, 2.96; 95% CI, 1.96 to 4.46; p < 0.001), whereas there was no significant excess risk of PCI relative to CABG for stroke (HR, 0.85; 95% CI, 0.50 to 1.41; p = 0.52). In conclusion, there was no excess long-term mortality risk of PCI relative to CABG, while the excess risks of PCI relative to CABG were significant for myocardial infarction and any coronary revascularization in the present study population reflecting real-world clinical practice in Japan., Competing Interests: Declaration of interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Inc. All rights reserved.)

There is a scarcity of data comparing long-term clinical outcomes between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel coronary artery disease (3VD) in the new-generation drug-eluting stents era. CREDO-Kyoto PCI/CABG registry Cohort-3 enrolled 14927 consecutive patients who had undergone first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013. We identified 2525 patients with 3VD (PCI: n = 1747 [69%], and CABG: n = 778 [31%]). The primary outcome measure was all-cause death. Median follow-up duration was 5.7 (interquartile range: 4.4 to 6.6) years. The cumulative 5-year incidence of all-cause death was significantly higher in the PCI group than in the CABG group (19.8% vs 13.2%, log-rank p = 0.001). After adjusting confounders, the excess risk of PCI relative to CABG for all-cause death remained significant (HR, 1.45; 95% CI, 1.14 to 1.86; p = 0.003), which was mainly driven by the excess risk for non-cardiovascular death (HR, 1.88; 95% CI, 1.30 to 2.79; p = 0.001), while there was no excess risk for cardiovascular death between PCI and CABG (HR, 1.19; 95% CI, 0.87 to 1.64; p = 0.29). There was significant excess risk of PCI relative to CABG for myocardial infarction (HR, 1.77; 95% CI, 1.19 to 2.69; p = 0.006), whereas there was no excess risk of PCI relative to CABG for stroke (HR, 1.24; 95% CI, 0.83 to 1.88; p = 0.30). In conclusion, in the present study population reflecting real-world clinical practice in Japan, PCI compared with CABG was associated with significantly higher risk for all-cause death, while there was no excess risk for cardiovascular death between PCI and CABG., Competing Interests: Declaration of Interests The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this study., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: To report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the IMPERIAL Randomized Controlled Trial (RCT)., Materials and Methods: IMPERIAL RCT is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30-140 mm, Rutherford category 2-4) treated with the Eluvia paclitaxel-eluting nitinol stent or the Zilver PTX paclitaxel-coated stent. Two-year follow-up included patency, safety, and mortality assessments and core laboratory-reviewed B-mode ultrasound imaging to screen for hypoechogenic halo in the stented segment, and assess blood flow., Results: At 24 months, all-cause mortality was 7.1% (21/295) for Eluvia and 8.3% (12/145) for Zilver PTX (P = 0.6649). The clinically driven target lesion revascularization rate was significantly less for patients treated with Eluvia vs Zilver PTX (12.7% vs 20.1%; P = 0.0495). The Kaplan-Meier estimate of primary patency at 24 months was 83.0% for Eluvia and 77.1% for Zilver PTX (log rank P = 0.1008). Transverse ultrasound imaging was implemented during the 24-month follow-up window and was evaluable for 27.5% (128/465) of patients. Hypoechogenic halo prevalence rates did not differ significantly between Eluvia and Zilver PTX study arms (33.7% [29/86] vs 21.4% [9/42]; P = 0.153). In no case was flow documented within the halo; no adverse events were associated with these ultrasound findings., Conclusion: Two-year follow-up suggests a sustained advantage for Eluvia for avoiding target lesion revascularization. Initial hypoechogenic halo assessment showed no difference in prevalence between the study arms, no flow within the halo, and no associated adverse events., Clinical Trial Registration: clinicaltrials.gov identifier NCT02574481. Date of registration: October 14, 2015., Level of Evidence: Level 1; randomized controlled trial.

Objectives: To evaluate patient characteristics and long-term outcomes in patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) in the past two decades., Design: Multicenter retrospective study., Setting: The Coronary REvascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG) Registry Cohort-2 (2005-2007) and Cohort-3 (2011-2013)., Participants: 3254 patients with NSTEACS who underwent first coronary revascularisation., Primary and Secondary Outcome Measures: The primary outcome was all-cause death. The secondary outcomes were cardiovascular death, cardiac death, sudden cardiac death, non-cardiovascular death, non-cardiac death, myocardial infarction, definite stent thrombosis, stroke, hospitalisation for heart failure, major bleeding, any coronary revascularisation and target vessel revascularisation., Results: Patients in Cohort-3 were older and more often had heart failure at admission than those in Cohort-2. The prevalence of PCI, emergency procedure and guideline-directed medical therapy was higher in Cohort-3 than in Cohort-2. In patients who received PCI, the prevalence of transradial approach, drug-eluting stent use and intravascular ultrasound use was higher in Cohort-3 than in Cohort-2. There was no change in 3-year adjusted mortality risk from Cohort-2 to Cohort-3 (HR 1.00, 95% CI 0.83 to 1.22, p=0.97). Patients in Cohort-3 compared with those in Cohort-2 were associated with lower adjusted risks for stroke (HR 0.65, 95% CI 0.46 to 0.92, p=0.02) and any coronary revascularisation (HR 0.76, 95%CI 0.66 to 0.87, p<0.001), but with higher risk for major bleeding (HR 1.25, 95% CI 1.06 to 1.47, p=0.008). The unadjusted risk for definite stent thrombosis was lower in Cohort-3 than in Cohort 2 (HR 0.29, 95% CI 0.11 to 0.67, p=0.003)., Conclusions: In the past two decades, we did not find improvement for mortality in patients with NSTEACS. We observed a reduction in the risks for definite stent thrombosis, stroke and any coronary revascularisation, but an increase in the risk for major bleeding., Competing Interests: Competing interests: HS reports personal fees from Abbott Vascular, Boston Scientific and Daiichi Sankyo. TM reports lecturer’s fees from Bayer, Daiichi Sankyo, Japan Lifeline, Kyocera, Mitsubishi Tanabe, Novartis and Toray; the manuscript fees from Bristol-Myers Squibb and Kowa; served advisory boards for Asahi Kasei, Boston Scientific, Bristol-Myers Squibb and Sanofi. NE reports personal fees from Abbott Vascular, Medtronic, Terumo, Bayer, Boston Scientific, Daiichi-Sankyo, Edwards Lifescience, Pfizer, Bristol Myers Squibb, Takeda and Boehringer Ingelheim. YF reports personal fees from Daiichi Sankyo, Bayer, Sanofi, Kowa, Pfizer, Bristol-Myers Squibb, Otsuka Parmaceutical, Sumitomo Dainippon Pharma, Takeda and Ono Pharmaceutical. YN reports grant from Abbott Vascular and Boston Scientific, and reports personal fees from Abbott Vascular, Bayer, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo. TK reports personal fees from Abbott Vascular, MSD, Eisai, Edwards Lifescience, Ono Pharmaceutical, Tsumura, Medical Review, Kowa, Sanofi, Daiichi Sankyo, Takeda Pharmaceutical, Pharmaceuticals and Medical Devices Agency, Abiomed, Bayer, Bristol-Myers Squibb, Boston Scientific, Lifescience, Toray, Astellas Amgen Biopharma, Astellas, AstraZeneca, Otsuka Parmaceutical, OrbusNeich, MSD Life Science Foundation, Public Health Research Foundation, Chugai Pharmaceutical, Boehringer Ingelheim, Japan Society for the Promotion of Science, Interscience, Philips, Kowa Pharmaceutical, Mitsubishi Tanabe Pharma, Terumo, Novartis Pharma and Sumitomo Dainippon Pharma., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.

Aim: Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX., Methods: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year., Results: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P=0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p=0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P=0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P=0.08). Stent thrombosis was not observed in either group., Conclusion: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions.

Purpose: The purpose of the study is to report 12-month efficacy and safety results from the subgroup of Japanese patients in the prospective IMPERIAL 2:1 randomized controlled trial (RCT)., Methods: The global IMPERIAL RCT was designed to compare performance of the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific, Marlborough, MA, USA) with the Zilver PTX Drug-Eluting Peripheral Stent (Cook Medical, Bloomington, IN, USA) for treatment of femoropopliteal artery lesions. Patients with symptomatic (Rutherford category 2-4) disease were included. Post-procedural technical success was defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% by visual assessment. Twelve-month assessments included primary patency (core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤ 2.4 in the absence of clinically driven TLR or bypass of the target lesion) and major adverse events (MAEs)., Results: Fifty-six patients in the Eluvia group and 28 in the Zilver PTX group were treated at Japanese centers. Mean lesion length was 91.8 ± 38.0 mm for Eluvia and 87.4 ± 41.7 mm for Zilver PTX. Technical success was 100% for both groups. At 12 months, the observed primary patency rate was 90.9% for Eluvia and 84.6% for Zilver PTX. The 12-month MAE rate was 1.8% for Eluvia and 7.7% for Zilver PTX. All MAEs were clinically driven TLRs., Conclusion: The results show excellent vessel patency and a good safety profile up to 1 year in the subgroup of Japanese patients in IMPERIAL treated with Eluvia for femoropopliteal artery disease., Level of Evidence: Level 3; subgroup analysis of randomized trial., Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02574481.

Purpose: To examine if endovascular therapy (EVT) with paclitaxel-coated stents increases the mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD)., Materials and Methods: A retrospective analysis was conducted of paclitaxel-coated stent use in the femoropopliteal segment of 1535 symptomatic (Rutherford category 2 to 4) patients treated between January 2010 and December 2016 at 4 hospitals in Japan. The risk of all-cause mortality was examined between the 285 patients (mean age 73±8 years; 213 men) treated with a paclitaxel-coated stent (PTX-coated group) and 1250 patients (mean age 73±9 years; 872 men) not exposed to a paclitaxel-coated device (PTX-free group) during EVT. Propensity score matching was employed to balance baseline characteristics. Cox proportional hazards models stratified on the quintiles of the propensity score were used to investigate paclitaxel-coated stent use and mortality risk as well as interactions among baseline variables and the main outcome. Interactions between a PXT-coated stent and subgroups of the PTX-free group (bare stent and angioplasty) were also investigated, as was the impact of paclitaxel dose on mortality risk. The results of regression analysis are reported as the hazard ratio (HR) and 95% confidence interval (CI)., Results: The 3-year overall survival estimates were 86.4% in the PTX-coated group vs 87.7% in the PTX-free group; the corresponding 5-year estimates were 77.5% vs 73.7%, respectively. There was no significant difference in all-cause mortality between the 2 groups (HR 0.89, 95% CI 0.66 to 1.19, p=0.41). The cause of death also showed no remarkable difference between the groups. Chronic renal failure (p=0.044) and arterial calcification (p=0.022) demonstrated a significant interaction effect on the association of the use of a PTX-coated stent with all-cause mortality. No subgroup demonstrated that the use of a paclitaxel-coated stent was associated with an increased risk of all-cause mortality. A dose dependency was not evident., Conclusion: Mortality risk following application of a PTX-coated stent did not increase over 5 years, irrespective of the dose. A PTX-coated stent for femoropopliteal lesions in PAD patients is a safe treatment option.

Background: The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions., Methods: In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of -10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481., Findings: Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI -0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI -0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation., Interpretation: The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease., Funding: Boston Scientific., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: New-generation bare-metal nitinol (BNS) and drug-eluting stents have improved long-term outcomes in patients undergoing endovascular therapy for femoropopliteal lesions. Furthermore, cilostazol reduces in-stent restenosis (ISR) after first-generation BNS implantation for femoropopliteal lesions., Methods and Results: We studied 255 patients with femoropopliteal lesions treated at 25 cardiovascular centers. Patients were randomly assigned to the BNS group (Misago stent implantation without cilostazol), BNS with cilostazol group (Misago stent implantation with cilostazol), or drug-eluting stents group (Zilver PTX stent implantation without cilostazol). Primary end point was 1-year restenosis noted using duplex ultrasound (peak systolic velocity ratio, >2.0). Secondary end point was major adverse limb events (limb-related death, target lesion revascularization, major amputation, and major bleeding). During the 1-year follow-up, 12 patients (4.7%) died and 237 (92.9%) had relevant ultrasound findings. The 1-year ISR rate did not differ significantly among the BNS, BNS with cilostazol, and drug-eluting stents groups (28.4% versus 12.2% versus 21.0%; P=0.052). Although the 1-year ISR rate was significantly lower in the BNS with cilostazol group than in the BNS group, it was similar to that in the drug-eluting stents group ( P=0.16). Major adverse limb event was significantly higher in the BNS group (16.9% versus 6.5% versus 6.3%; P=0.034); however, target lesion revascularization and major bleeding were similar (9.7% versus 5.1% versus 3.6%; P=0.25, 4.8% versus 1.2% versus 2.4%; P=0.37, respectively)., Conclusions: Misago stent implantation with cilostazol showed a comparable 1-year ISR rate with Zilver PTX. Cilostazol reduced the 1-year ISR rate after endovascular therapy when used with new-generation BNS., Clinical Trial Registration: URL: http://www.umin.ac.jp/ctr/ . Unique identifier: UMIN 000010071.

Unlike coronary arteries, little is known about peri-stent contrast staining (PSS) formation after drug-eluting stent (DES) implantation for infrapopliteal arteries. Herein, we report exacerbated PSS assessed by serial angiography and optical coherence tomography (OCT) after platinum-chromium everolimus-eluting stent (PtCr-EES) implantation for infrapopliteal artery lesions. A 68-year-old women with recurrent left critical limb ischemia was admitted to our hospital. Standard endovascular techniques were performed for the popliteal artery (POP) and tibioperoneal trunk (TPT), but residual stenosis occurred. Therefore, a 4.0 × 38-mm PtCr-EES was placed from the distal POP to TPT using OCT guidance. Ten months later, the patient was referred to our hospital due to recurrent left leg rest pain. Angiography showed severe stenosis from the distal POP to the proximal site of the stent, and diffuse in-stent restenosis (ISR). At the ISR site, stent fracture and compression were observed and vessel evaginations were newly detected on OCT. At that time, good angiographic results were obtained by conventional balloon angioplasty alone. At 6 months follow-up, recurrence of ISR was suspected on duplex ultrasonography. Angiography showed no significant ISR, but PSS had markedly exacerbated from focal type to segmental type. OCT showed exacerbated vessel evagination and in-stent thrombus. The incidence and clinical impact of PSS after DES implantation in infrapopliteal artery lesions remain unclear; therefore, careful follow-up may be needed in such cases.

Background: Percutaneous coronary intervention for heavily calcified lesions requires rotational atherectomy (RA). Long-term clinical outcomes after drug-eluting stent (DES) implantation following (RA) for heavily calcified lesions remain unclear. We assessed 5-year clinical outcomes after DES implantation following RA., Methods and results: Between March 2006 and September 2011, 219 consecutive patients with 219 lesions treated with DES following RA, were retrospectively enrolled. The cumulative 5-year incidence of target-lesion revascularization (TLR) and definite stent thrombosis (ST) were assessed. The cumulative incidence of TLR within (≤) the first year was 18.6%. Late TLR beyond (>) 1 year continued to occur at 1.9% per year without a decrease in the rate (5-year incidence, 26.0%). The cumulative incidence of definite ST at 30 days, 1 and 5 years was 0.9%, 2.3% and 2.9%, respectively. The annual rate of definite ST beyond 1 year was 0.15%. On multivariate analysis, the significant predictor of TLR within 1 year was use of first-generation DES (hazard ratio [HR], 2.09; 95% CI: 1.10-4.03, P=0.02) and that of TLR beyond 1 year was hemodialysis (HR, 3.29; 95% CI: 1.06-10.55, P=0.04)., Conclusions: Late TLR beyond 1 year continued to occur up to 5 years at a constant annual incidence, whereas very late ST was rare. Careful long-term clinical follow-up is continually needed in patients who have already received DES following RA for heavily calcified lesions.

The incidence and long-term clinical impact of stent fracture (SF) occurred beyond 1 year after sirolimus-eluting stent (SES) implantation remains unclear. From April 2004 to March 2008, 985 consecutive patients with 1,307 lesions were treated only with SES. Of these, 868 patients (88.1%) with 1,140 lesions underwent follow-up angiography within 1 year after the index procedure, and 646 patients (65.6%) with 872 lesions underwent it both within and beyond 1 year after the index procedure. According to the diagnosed timing of SF, we divided the patients into the 2 groups: early SF (<1 year after the index procedure) and late-acquired SF (>1 year after the index procedure). Early- and late-acquired SFs were observed in 64 of 868 patients (7.4%) and 66 of 1,140 lesions (5.8%); 12 of 646 patients (1.9%) and 12 of 872 lesions (1.4%), respectively. Cumulative 10-year incidence of clinically driven target lesion revascularization and definite stent thrombosis were numerically higher in the early- and late-acquired SF groups than in the non-SF group (41.6% vs 45.5% vs 19.0%; 8.0% vs 8.3% vs 2.0%, respectively). In conclusion, late-acquired SF after SES implantation occurred in 1.4% of lesions, which was lower than that of early SF. However, both early- and late-acquired SFs appeared to be associated with clinically driven target lesion revascularization and stent thrombosis during the long-term follow-up., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The mechanism and time course of in-stent restenosis (ISR) after implantation of second-generation DES have not yet been fully elucidated. We sought to evaluate the differences in tissue characteristics between the different phases of ISR after second-generation DES implantation using optical coherence tomography (OCT).Methods and Results:From June 2010 to December 2015, 324 consecutive patients with 337 ISR lesions underwent OCT. Of these, we analyzed 53 lesions in 53 patients who had their first ISR after second-generation DES implantation and underwent OCT before any procedures. According to the timing of ISR, the patients were divided into the early group (within 1 year: E-ISR, n=30) and late group (beyond 1 year: L-ISR, n=23). Quantitative parameters and qualitative characteristics of the neointima were evaluated. In the minimum lumen area site analysis, the E-ISR group had more frequently homogeneous intima than the L-ISR group (26.7% vs. 4.4%, P=0.02). The frequencies of neointima with lipid-laden, thin-cap fibroatheroma, neovascularization and macrophage infiltration were significantly higher in the L-ISR group than in the E-ISR group (30.0% vs. 69.6%, P<0.01; 0.0% vs. 26.1%, p <0.01; 6.7% vs. 26.1%, P=0.049; 3.3% vs. 26.1%, P=0.01, respectively)., Conclusions: Neointimal tissue characteristics differed between E-ISR and L-ISR after second-generation DES implantation. E-ISR was mainly caused by neointimal hyperplasia, whereas neoatherosclerosis was the main mechanism of L-ISR.

Background: Cilostazol improves clinical endovascular therapy outcomes for femoropopliteal (FP) lesions in patients with symptomatic peripheral arterial disease, but whether it also has clinical benefits for patients after drug-eluting stent implantation remains unclear., Methods: This study is a subanalysis of the ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy (ZEPHYR) study, a prospective multicenter study investigating FP lesions treated with the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent. The present study analyzed 475 lesions in 459 limbs of 399 patients who maintained therapy with aspirin and thienopyridine, with or without cilostazol, during the 1-year follow-up period., Results: Restenosis rates at 1 year were assessed with duplex ultrasound imaging (peak systolic velocity ratio >2.4) or angiography (≥50% diameter stenosis) and compared in the groups with and without cilostazol. Propensity score matching was performed to minimize intergroup differences in baseline characteristics. The present study included 93 cilostazol-treated and 382 cilostazol-free cases. Among the patients, 71% had diabetes mellitus and 31% were on dialysis. Critical limb ischemia accounted for 29% of cases. The prevalence of de novo lesions was 76%, and in-stent restenosis was present in 15%. Propensity score matching was performed in 91 pairs. The 1-year restenosis rate was 33% (95% confidence interval [CI], 23%-43%) in the cilostazol-treated group and 51% (95% CI, 41%-62%) in the cilostazol-free group (P = .008). The odds ratio was 0.5 (95% CI, 0.3-0.8)., Conclusions: The propensity score-matching analysis demonstrated that additional cilostazol administration was associated with a significantly lower restenosis incidence 1 year after drug-eluting stent implantation for FP lesions., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: The objective was to assess whether total stent length (TSL) after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation was associated with long-term clinical outcomes., Background: The impact of TSL after CoCr-EES implantation on long-term clinical outcomes remained unclear., Methods: A total of 1,007 consecutive patients with 1,382 lesions treated only with CoCr-EES were analyzed. Patients and lesions were divided into tertile group: TSL per patient (TSL-P) (PA [8-23 mm], n = 382; PB [23-46 mm], n = 312; and PC [46-204 mm], n = 313), and TSL per lesion (TSL-L) (LA [8-18 mm], n = 486; LB [18-28 mm], n = 475; and LC [28-140 mm], n = 421). The cumulative 3-year incidence of clinically driven target-lesion revascularization (CD-TLR) and definite stent thrombosis (ST) based on TSL-P and TSL-L groupings were accessed., Results: After inverse probability of weighted adjustment, the cumulative 3-year incidence of CD-TLR for the TSL-P and TSL-L were higher in the PC and LC groups than in the other groups (hazard ratio [HR] 2.92, 95% confidence intervals [CI] 1.66-5.15, P < 0.001 vs. PA; HR 2.49, 95% CI 1.47-4.20, P < 0.001 vs. PB; HR 1.94, 95% CI 1.15-3.28, P = 0.01 vs. LA; HR 2.80, 95% CI 1.73-4.54, P < 0.001 vs. LB, respectively). No significant differences in the cumulative 3-year incidence of definite ST were observed in both TSL-P and TSL-L groups., Conclusions: TSL after CoCr-EES implantation has significantly impact on CD-TLR rate through 3 years, but it is not associated with an increased incidence of definite ST. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Objective: Although clinical trials demonstrated the superiority of the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent (PTX), a recently developed drug-eluting stent (DES), to conventional therapy for femoropopliteal (FP) lesions, the incidence and risk factors of the repetition of reintervention after DES implantation in clinical practice remained unrevealed., Methods: This was a subanalysis of the ZEPHYR (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) study, enrolling FP lesions undergoing endovascular therapy (EVT) with DES implantation. The current study analyzed the 2-year database including 583 FP lesions in 495 patients undergoing preoperative intravascular ultrasound imaging before DES implantation. The primary outcome measure was re-re-EVT, defined as undergoing additional EVT more than once during the 2-year follow-up after DES implantation. The secondary outcome measure was re-EVT, defined as undergoing at least one additional EVT during the follow-up., Results: Critical limb ischemia (CLI) was present in 28% of the study population, 23% had a history of EVT, and 43% had chronic total occlusion. Mean lesion length was 16 ± 10 cm, and intravascular ultrasound imaging-evaluated external elastic membrane area was 28 ± 10 mm 2 . The cumulative incidence rate of re-re-EVT at 2 years was estimated to be 14%, whereas that of re-EVT was 31%. After multivariate analysis, CLI and smaller external elastic membrane area were independently associated with the outcome., Conclusions: The incidence and risk factors of the repetition of reintervention after DES implantation for FP lesions were revealed. The current findings suggest that DES implantation might be a careful indication in CLI cases especially with a small vessel., (Copyright © 2016. Published by Elsevier Inc.)

Purpose: To report midterm outcomes after subintimal vs intraluminal drug-eluting stent (DES) implantation for femoropopliteal (FP) chronic total occlusion (CTO)., Methods: This subanalysis of the prospective, multicenter ZEPHYR study (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) included 176 patients (mean age 74±8 years; 130 men) with 192 de novo FP CTOs that were evaluated by intravascular ultrasound after successful guidewire crossing. The primary outcome was the 2-year restenosis rate after subintimal (n=73) or intraluminal (n=119) DES implantation. Propensity score matching extracted 61 matched pairs (mean age 75 years; 49 men) for patency analysis to minimize baseline intergroup differences. Restenosis rates are reported with the 95% confidence interval (CI)., Results: The 1-year restenosis rates in the groups with subintimal and intraluminal DES implantation were 45% (95% CI 32% to 59%) and 35% (95% CI 22% to 49%), respectively (p=0.352), whereas the corresponding rates at 2 years were not significantly different (p=0.648) at 56% (95% CI 41% to 71%) and 51% (95% CI 34% to 68%). Baseline characteristics had no significant interaction effect on the association of subintimal angioplasty with restenosis risk., Conclusion: In FP CTO, 2-year restenosis rates were comparable after subintimal or intraluminal DES implantation., (© The Author(s) 2016.)

Background: Biolimus-eluting stents (BES) have similar efficacy and safety compared with cobalt chromium everolimus-eluting stents (CoCr-EES), whereas it is unclear whether the same applies to small vessel disease. We sought compare clinical outcomes between BES and CoCr-EES in patients with small vessel disease., Methods and Results: A total of 1,132 patients treated only with BES (612 patients) or EES (520 patients) in small vessel disease (stent size 2.5-mm) were retrospectively analyzed. We assessed the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiac death, myocardial infarction (MI), definite stent thrombosis (ST), and clinically driven target lesion revascularization (CD-TLR). The cumulative 2-year incidence of MACE was similar between the two groups (12.1% vs. 11.8%, P = 0.77). The cumulative incidence of cardiac death, CD-TLR, and definite ST were also not significantly different between both groups (3.2% vs. 3.6%, P = 0.78; 8.3% vs. 8.4%, P = 1.00; 0.33% vs. 0.21%, P = 0.66, respectively). After multivariate adjusting, the adjusted risk of BES group relative to CoCr-EES group for MACE was not significantly different (hazard ratio [HR]: 0.78, 95% confidential interval [CI]: 0.53-1.15, P = 0.20). Similarly, no significant difference in the adjusted risks for cardiac death and CD-TLR were observed between the two groups (HR: 0.62, 95% CI: 0.28-1.37, P = 0.24; HR: 0.81, 95% CI: 0.51-1.29, P = 0.38)., Conclusions: Two-year clinical outcomes of BES are similar to those of CoCr-EES in patients with small vessel disease. The use of BES is acceptable for small coronary artery disease. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Purpose: To compare drug-eluting stent (DES) implantation with percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal in-stent restenosis (ISR)., Methods: A comparison was performed of data from 112 ZEPHYR registry patients (mean age 74±9 years; 60 men) with 119 femoropopliteal ISR lesions treated with a drug-eluting stent (Zilver PTX) with historical data from 116 patients (mean age 72±8 years; 83 men) with 133 lesions treated with PTA. The patients were stratified for analysis by lesions with (101/252, 40%) and without (n=151) in-stent occlusion. The primary outcome measure was the 1-year incidence of recurrent restenosis; the secondary outcome was major adverse limb events (MALE). Multivariate logistic regression analysis was performed to look for any independent association of DES implantation with 1-year recurrent restenosis in the respective subgroups; results are presented as the odds ratio (OR) and 95% confidence interval (CI)., Results: In the subgroup without in-stent occlusion, there was no significant difference between DES and PTA in the 1-year incidence of recurrent restenosis (40.5% vs 45.7%, p=0.583, respectively) or MALE (27.8% vs 20.7%, p=0.322, respectively). However, in the subgroup with in-stent occlusion, DES implantation was associated with significantly lower incidences of recurrent restenosis (44.1% vs 90.3% for PTA, p<0.001) and MALE (25.5% vs 53.6% for PTA, p<0.001). Multivariate analysis confirmed that DES implantation had a significant independent negative association with the risk of recurrent restenosis in the subgroup with occlusion (OR 0.2, 95% CI 0.1 to 0.6, p=0.006)., Conclusion: DES implantation may be more effective than PTA in the management of femoropopliteal ISR with occlusion, but equally effective to PTA in nonocclusive ISR lesions. These results require confirmation in prospective randomized studies., (© The Author(s) 2016.)

Purpose: To compare optimal balloon angioplasty with nitinol stenting and drug-eluting stent (DES) implantation for femoropopliteal in-stent occlusion (ISO)., Methods: A dual center, retrospective study was performed from January 2004 to December 2014 encompassing 110 ISOs after bare nitinol stenting for a femoropopliteal lesion in 100 patients (mean age 72.7±10.1 years; 58 men). These patients underwent optimal balloon angioplasty with implantation of a bare stent (conventional group, n=79) or a DES (n=21). The primary endpoint was recurrent in-stent restenosis (Re-ISR); secondary endpoints were recurrent target lesion revascularization (Re-TLR), reocclusion, and major adverse limb events (MALE). Re-ISR or reocclusion was defined as ISR or occlusion after TLR. Restenosis was defined as a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography. Univariate Cox regression analysis was used to identify any relationships between patient and procedure variables and the occurrence of Re-ISR; the results are presented as the hazard ratio (HR) and the 95% confidence interval (CI)., Results: The mean follow-up period was 34.9±27.4 months. At 2 years, Kaplan-Meier estimated freedom from Re-ISR rates were 79.3% in the DES group and 20.2% in the conventional group, respectively (p<0.001). The rates of freedom from Re-TLR, reocclusion, and MALE at 2 years were 85.7%, 85.9%, and 85.7% in the DES group and 27.1%, 42.5%, and 25.3% in the conventional group, respectively (p<0.001, p=0.006, and p<0.001, respectively). Univariate analysis showed only postprocedure stenosis (HR 1.04, 95% CI 1.02 to 1.07, p<0.001) as a predictor of Re-ISR. Postprocedure ABI (HR 0.06, 95% CI 0.01 to 0.30, p<0.001) and DES use (HR 0.20, 95% CI 0.07 to 0.44, p<0.001) were associated with a lower likelihood of developing Re-ISR., Conclusion: In this small comparative study, DES stent implantation gives more favorable outcomes than conventional treatment for ISO after femoropopliteal stenting., (© The Author(s) 2016.)

Objectives: This study sought to investigate the characteristics of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation for femoropopliteal (FP) lesions, and to examine 1-year prognosis after repeat endovascular therapy (re-EVT) for these DES-ISR., Background: The morphology of DES-ISR and its association with clinical outcomes after re-EVT have not been well examined., Methods: This was a subanalysis of the ZEPHYR (Zilver PTX for the femoral artery and proximal popliteal artery) study. The current study included 210 cases with loss of patency confirmed 1 year after DES implantation. Morphology of DES-ISR was classified into the following subgroups: class I, focal lesions (≤50 mm in length), class II, diffuse lesions (>50 mm in length), and class III, totally occluded ISR. One-year prognosis after re-EVT for DES-ISR was assessed by restenosis and major adverse limb events (MALE)., Results: Classes I, II, and III accounted for 50%, 25%, and 25% of DES-ISR, respectively. Factors associated with the morphology of DES-ISR were the presence of chronic total occlusion and the size of the external elastic membrane area before DES implantation (p = 0.009 and 0.017). Compared with the class I restenotic lesion, the class II and III lesions had a significantly higher risk of restenosis (74% and 78% vs. 53%: p = 0.048 and 0.019, respectively) and MALE (56% and 56% versus 32%: p = 0.025 and 0.022, respectively) 1 year after re-EVT., Conclusions: We evaluated the characteristics of ISR after DES implantation for FP lesions and 1-year prognosis of re-EVT for DES-ISR. The morphology of DES-ISR had a significant association with 1-year prognosis after re-EVT., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS)., Methods: A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis., Results: The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup., Conclusion: These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions., (© The Author(s) 2015.)

Aims: The Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES) is a newly developed drug-eluting stent (DES) that consists of a thin-strut, cobalt chromium with bioresorbable polymer coated only albuminally. We sought to compare tissue coverage in coronary lesions treated with BP-SES with the XIENCE permanent polymer everolimus-eluting stent (PP-EES) using optical coherence tomography (OCT)., Methods and Results: A total of 36 patients participated in the CENTURY II trial in our institution and were randomly assigned to BP-SES (n = 15) and PP-EES (n = 21). Of these, 27 patients (13 BP-SES and 14 PP-EES) underwent OCT at 9-month follow-up. Tissue coverage and apposition were assessed on each strut, and the results in both groups were compared using multilevel logistic or linear regression models with random effects at three levels: patient, lesion, and struts. A total of 6450 struts (BP-SES, n = 2951; PP-EES, n = 3499) were analysed. Thirty and 79 uncovered struts (1.02 and 2.26%, P = 0.35), and 3 and 4 malapposed struts (0.10 and 0.11%, P = 0.94) were found in BP-SES and PP-EES groups, respectively. Mean neointimal thickness did not significantly differ between both groups (110 ± 10 vs. 93 ± 10 µm, P = 0.22). No significant differences in per cent neointimal volume obstruction (13.2 ± 4.6 vs. 10.5 ± 4.9%, P = 0.14) or other areas-volumetric parameters were detected between both groups., Conclusion: BP-SES shows an excellent vascular healing response at 9-month follow-up, which is similar to PP-EES., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objectives: This study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES)., Background: SF remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era., Methods: From March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure., Results: SF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio [OR]: 14.2, 95% confidence intervals [CI]: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%)., Conclusions: SF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the rate and predictors of 1-year restenosis after drug-eluting stent implantation for femoropopliteal (FP) lesions in patients with peripheral arterial disease., Background: Zilver PTX, a paclitaxel-eluting stent for FP lesions, provides superior outcomes to angioplasty and bare-metal stents in clinical trials. However, its real-world outcomes and the associated features remain unclear., Methods: This was a prospective multicenter study enrolling 831 FP lesions (797 limbs, 690 patients) treated by Zilver PTX implantation. The primary endpoint was 1-year restenosis. Secondary endpoints included major adverse limb event and stent thrombosis., Results: Mean lesion length was 17 ± 10 cm. One-year restenosis, major adverse limb event, and stent thrombosis rates were 37%, 22%, and 2%, respectively. The generalized linear mixed model showed that lesion length ≥16 cm assessed by angiography and distal external elastic membrane area ≤27 mm(2) and minimum stent area ≤12 mm(2) assessed by intravascular ultrasound were independent risk factors for restenosis. One-year restenosis rates were 15% in cases with none of these risk factors and 50% in those with ≥2 risk factors., Conclusions: The current study demonstrated 1-year real-world outcomes after drug-eluting stent treatment for FP lesions, including challenging ones in clinical practice. Lesion length, external elastic membrane area, and minimum stent area were independent predictors for restenosis. (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery-Prospective Multicenter Registry [ZEPHYR]; UMIN000008433)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

A 71-year-old man underwent endovascular therapy (EVT) with a paclitaxel-eluting stent in superficial femoral artery (SFA). Optical coherence tomography (OCT) of SFA at 2 months after EVT revealed that several struts were not covered with neointima. Moreover, some mural thrombi were detected within the stent. Although OCT revealed that the frequency of stent strut coverage was improved at the 4-month follow-up, uncovered stent strut still remained and some mural thrombi were observed within the stent even at 4 months after EVT. This is the first report to demonstrate the vascular response after paclitaxel-eluting stent placement for the lesion using serial OCT examinations.

Purpose: To compare the vascular response after paclitaxel-coated nitinol drug-eluting stent (Zilver PTX) implantation for superficial femoral artery lesions after 6 and 12 months using optical coherence tomography (OCT)., Methods: Serial OCT examinations were performed in 5 patients (4 men; mean age 78.4 ± 6.8 years) with 9 Zilver PTX stents at 6- and 12-month follow-up. Variables evaluated included neointimal thickness and apposition on each strut, the incidence of extrastent lumen (ESL), peristrut low-intensity area (PLIA), and neovascularization at 1-mm intervals., Results: A total of 249 matched cross-section images were evaluated and included 4788 and 4826 struts at 6 and 12 months, respectively. Mean neointimal thickness significantly increased from 480 to 540 µm between 6 and 12 months (p < 0.001). The percentage of uncovered struts tended to decrease at 12 months (3% vs. 2.3%, p = 0.054), whereas the percentage of malapposed struts were similar at both examinations (0.2% vs. 0.2%, p > 0.99). Although the incidence of ESL in cross sections was not different (35% vs. 31%, p = 0.29), median ESL area significantly increased from 6 to 12 months [0.12 (0.04-0.36) vs. 0.31 (0.14-0.59) mm(2), p = 0.003)]. The presence of PLIA (29% vs. 44%, p < 0.001) and neovascularization (14% vs. 27%, p < 0.001) increased from 6 to 12 months., Conclusion: These findings suggest that delayed vascular healing and persistent peristent inflammation may be present even at 12 months after Zilver PTX implantation., (© The Author(s) 2015.)

Background: Bypass surgery (BSX) as first-line therapy for Trans-Atlantic Inter-Society Consensus-II (TASCII) C/D femoropopliteal (FP) lesions is recommended. Recent reports have shown that a drug-eluting stent (DES) provides good durability up to the mid-term. We investigated clinical outcomes after BSX vs. DES for TASCII C/D FP lesions., Methods and results: As treatment of de novo TASCII C/D FP lesions, 274 patients who underwent DES implantation and 201 patients who had BSX were identified and analyzed. Each group had at least 1 year of follow-up data. The primary endpoint was binary restenosis. Secondary endpoints were major amputation, reintervention, reocclusion and major adverse limb event (MALE; including major amputation or any reintervention and restenosis). Before matching, the binary restenosis rate was significantly higher in the DES group than in the BSX group (42% vs. 18%, P<0.001). After propensity matching, the 1-year restenosis rate was still higher in the DES group (44% vs. 18%, P<0.001). The DES group also had a significantly higher incidence of reintervention and MALE. Major amputation and reocclusion showed no significant difference. The subsequent stratification analysis reconfirmed no significant interaction effect of any background characteristics on the association of DES implantation vs. BSX with the 1-year restenosis risk., Conclusions: BSX is still a feasible and recommended treatment for TASCII C/D FP lesions in Japanese patients, based on good durability up to 1 year.

Background: Clinical outcomes of implantation of the newer-generation drug-eluting stent (DES) following rotational atherectomy for heavily calcified lesions remain unclear in the real-world setting., Methods and results: We enrolled 252 consecutive patients (273 lesions) treated with newer-generation DES following rotational atherectomy. The primary endpoint was the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as cardiac death, myocardial infarction, clinically-driven target lesion revascularization, and definite stent thrombosis. Complete clinical follow-up information at 2-year was obtained for all patients. The mean age was 73.2±9.0 years and 155 patients (61.5%) were male. Cumulative 2-year incidence of MACE (cardiac death, myocardial infarction, clinically-driven target lesion revascularization and definite stent thrombosis) was 20.3% (7.0%, 2.1%, 18.1% and 2.1%, respectively). Predictors of MACE were presenting with acute coronary syndrome (hazard ratio [HR]: 3.80, 95% confidence interval [CI]: 1.29-11.2, P=0.02), hemodialysis (HR: 1.93, 95% CI: 1.04-3.56, P=0.04) and previous coronary artery bypass graft (HR: 2.26, 95% CI: 1.02-5.00, P=0.045)., Conclusions: PCI for calcified lesions requiring rotational atherectomy is still challenging even in the era of newer-generation DES.

Background: Stent fracture (SF) after drug-eluting stent implantation has become an important concern. The aim of this study was to assess the incidence, predictors, and clinical impact of SF after biolimus-eluting stent., Methods and Results: A total of 1026 patients with 1407 lesions undergoing the Nobori biolimus-eluting stent implantation and follow-up angiography within 9 months after index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by using plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months. SF was observed in 58 (4.1%) of 1407 lesions and 57 (5.5%) of 1026 patients. Lesions with hinge motion (OR 8.90, 95% CI 3.84 to 20.6, P<0.001), tortuosity (OR 4.16, 95% CI 1.75 to 9.88, P=0.001), and overlapping stents (OR 2.41, 95% CI 0.95 to 6.10, P=0.06) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9 months was numerically higher in the SF group than that in the non-SF group (12.0% versus 1.0%). Cumulative incidence of definite stent thrombosis within 9 months tended to be higher in the SF group than that in the non-SF group (1.7% versus 0.5%)., Conclusions: SF after biolimus-eluting stent occurs in 4.1% of lesions and appears to be associated with clinically driven target lesion revascularization.

Background: Stent fracture (SF) after drug-eluting stent implantation has recently become an important concern because of its potential association with in-stent restenosis and stent thrombosis. However, the incidence and clinical impact of SF after everolimus-eluting stent implantation remain unclear., Methods and Results: A total of 1035 patients with 1339 lesions undergoing everolimus-eluting stent implantation and follow-up angiography 6 to 9 months after index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy or intravascular ultrasound during follow-up. We assessed the rates of SF and major adverse cardiac events, defined as cardiac death, myocardial infarction, stent thrombosis, and clinically driven target lesion revascularization within 9 months. SF was observed in 39 of 1339 lesions (2.9%) and in 39 of 1035 patients (3.8%). Ostial stent location and lesions with hinge motion, tortuosity, or calcification were independent predictors of SF. The rate of myocardial infarction and target lesion revascularization were significantly higher in the SF group than in the non-SF group (5.1% versus 0.4%; P=0.018 and 25.6% versus 2.0%; P<0.001, respectively). Stent thrombosis was more frequently observed in the SF group than in the non-SF group (5.1% versus 0.4%; P=0.018). Major adverse cardiac events within 9 months were significantly higher in the SF group than in the non-SF group (25.6% versus 2.3%; P<0.001)., Conclusions: SF after everolimus-eluting stent implantation occurs in 2.9% of lesions and is associated with higher rate of major adverse cardiac events, driven by higher target lesion revascularization and stent thrombosis.

Objectives: Our aim was to study the relationships between total stent length (TSL) and long-term clinical outcomes after sirolimus-eluting stent (SES) implantation., Background: SES compared with bare-metal stent use for long lesion treatment is associated with reduced restenosis rates., Methods: Three-year follow-up data were available for 10,773 patients (14,651 lesions) that had been treated with only SES (Cypher, Cordis Corp., Warren, New Jersey) in the j-Cypher registry. Patients and lesions were divided into quartile groups: TSL per patient (Q1: 8 to 23 mm, Q2: 24 to 36 mm, Q3: 37 to 54 mm, Q4: 55 to 293 mm), and TSL per lesion (QA: 8 to 18 mm, QB: 19 to 23 mm, QC: 24 to 33 mm, QD: 34 to 150 mm)., Results: In per-lesion data, longer TSL increased target lesion revascularization (TLR) rates but did not increase stent thrombosis rates (p = 0.2324). In per-patient data, the incidences of TLR remarkably increased with increasing TSL. Incidence of composite of death and myocardial infarction also increased with increasing TSL; however, after adjustment for baseline differences, there was no statistical significance. Definite stent thrombosis rate in group Q4 was significantly higher than in other groups, both unadjusted (hazard ratio: 1.770, p = 0.0081) and adjusted (hazard ratio: 1.727, p = 0.0122) for baseline differences., Conclusions: TSL per lesion and patient had significantly impacts on TLR rates. Longer TSL per patient was associated with increased incidence of stent thrombosis through 3 years., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)