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.

中文翻译：

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在IMPERIAL比较Eluvia和Zilver PTX支架的IMPERIAL随机试验中治疗的日本患者。

目的本研究的目的是在前瞻性IMPERIAL 2：1随机对照试验（RCT）中报告日本患者亚组的12个月疗效和安全性结果。方法设计全球IMPERIAL RCT，以比较Eluvia药物洗脱血管支架系统（波士顿科学公司，美国马萨诸塞州马尔堡）和Zilver PTX药物洗脱外周支架（Cook Medical，美国布卢明顿，美国）的治疗效果股pop动脉病变。包括症状性（卢瑟福2-4类）疾病的患者。手术后的技术成功定义为通过目测评估将分配的研究支架递送和部署到目标病变处，以实现残余血管造影狭窄不超过30％。十二个月的评估包括主要通畅性（在没有临床驱动的TLR或未绕过靶病变的情况下，核心实验室评估的双工超声峰值收缩速比≤2.4）和主要不良事件（MAE）。结果Eluvia组的56例患者和Zilver PTX组的28例在日本中心接受了治疗。Eluvia的平均病变长度为91.8±38.0 mm，Zilver PTX的平均病变长度为87.4±41.7 mm。两组的技术成功率均为100％。在12个月时，观察到的主要通畅率是Eluvia为90.9％，Zilver PTX为84.6％。Eluvia和Zilver PTX的12个月MAE率为1.8％，Zilver PTX为7.7％。所有MAE都是临床驱动的TLR。结论结果显示，日本人亚美尼亚经Eluvia治疗股pop动脉疾病的IMPERIAL患者亚组中，其血管通畅性良好，长达1年具有良好的安全性。证据级别3级；随机试验的亚组分析。临床试验注册ClinicalTrials.gov，标识符NCT02574481。