Kokura Memorial Hospital, 3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka, 802-0001, Japan.
Kishiwada Tokushukai Hospital, Osaka, Japan.
Cardiovasc Intervent Radiol. 2020 Feb;43(2):215-222. doi: 10.1007/s00270-019-02355-x. Epub 2019 Nov 5.
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).
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).
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.
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 3; subgroup analysis of randomized trial.
ClinicalTrials.gov, identifier NCT02574481.
本研究旨在报告前瞻性 IMPERIAL 2:1 随机对照试验（RCT）中日本患者亚组的 12 个月疗效和安全性结果。
全球 IMPERIAL RCT 旨在比较 Eluvia 药物洗脱血管支架系统（波士顿科学公司，马萨诸塞州马尔伯勒）与 Zilver PTX 药物洗脱外周支架（库克医疗公司，印第安纳州布鲁明顿）治疗股腘动脉病变的疗效。纳入有症状（Rutherford 分类 2-4 级）疾病的患者。术后技术成功定义为将指定的研究支架输送至目标病变，通过视觉评估使残余血管造影狭窄程度不超过 30%。12 个月评估包括主要通畅率（核心实验室评估的双功能超声峰值收缩速度比≤2.4，且不存在临床驱动的 TLR 或目标病变旁路）和主要不良事件（MAEs）。
56 例 Eluvia 组和 28 例 Zilver PTX 组患者在日本中心接受治疗。Eluvia 组的平均病变长度为 91.8±38.0mm，Zilver PTX 组为 87.4±41.7mm。两组的技术成功率均为 100%。12 个月时，Eluvia 的观察到的主要通畅率为 90.9%，Zilver PTX 为 84.6%。Eluvia 的 12 个月 MAE 发生率为 1.8%，Zilver PTX 为 7.7%。所有 MAEs 均为临床驱动的 TLR。
在 IMPERIAL 中接受 Eluvia 治疗股腘动脉疾病的日本患者亚组中，1 年时的血管通畅率极佳，安全性良好。
3 级；随机试验的亚组分析。
ClinicalTrials.gov，标识符 NCT02574481。
