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.

中文翻译：

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在 Eluvia 药物洗脱支架和 Zilver PTX 药物涂层支架的 IMPERIAL 随机研究中，来自日本患者的 24 个月疗效和安全性结果。

目的 本研究的目的是报告日本患者队列在药物洗脱支架 (DES) 用于外周动脉疾病的前瞻性随机对照试验 (RCT) 中的 24 个月疗效和安全性结果。材料和方法 全球 IMPERIAL RCT 患者的股腘病变采用 Eluvia DES（Boston Scientific，Marlborough，MA，USA）或 Zilver PTX 药物涂层支架（Cook Medical，Bloomington，IN，USA）治疗。在 24 个月时，评估包括用于核心实验室血管通畅测量的双工超声成像、目标病变血运重建 (TLR) 率和临床结果测量。结果 日本队列包括 84 名患者（56 名接受 Eluvia 治疗，28 名接受 Zilver PTX）。临床驱动的 TLR 率为 5.6% (3/54) 和 18。接受 Eluvia 和 Zilver PTX 治疗的患者分别为 5% (5/27)（差异 -13.0%，95%CI -28.8，2.9%；p = 0.11）。接受 Eluvia 治疗的患者在 24 个月时免于临床驱动的 TLR 的 Kaplan-Meier 估计值为 94.3%，接受 Zilver PTX 治疗的患者为 80.4%（对数等级 p = 0.05），主要通畅率分别为 88.5% 和 80.4% ，分别（对数等级 p = 0.28）。死亡率分别为 5.6% (3/54) 和 11.1% (3/27)；p = 0.39。91.8% (45/49) 和 68.2% (15/22) 的患者 (p = 0.03) 的卢瑟福分类至少提高了一个类别，没有 TLR。随着时间的推移，步行障碍评分的改善得以持续。结论 24 个月时的结果支持 DES 在日本患者中的有效性和安全性，持续的临床改善和 Eluvia 治疗患者的再次干预数量减少。临床试验注册 Clinicaltrials.gov 标识符 NCT02574481。https://clinicaltrials.gov/ct2/show/NCT02574481 证据级别：EBM 三级；随机试验的队列分析。