Ohki Takao, Yokoi Hiroyoshi, Kichikawa Kimihiko, Kimura Takeshi, Snyder Scott A, Ragheb Anthony O, O'Leary Erin E, Jaff Michael R, Ansel Gary M, Dake Michael D
1 Department of Surgery, Jikei University Hospital, Tokyo, Japan.
J Endovasc Ther. 2014 Oct;21(5):644-53. doi: 10.1583/14-4753.1.
To report a subgroup analysis comparing safety and effectiveness outcomes in Japanese and non-Japanese patients as part of a prospective, multinational, randomized controlled trial (ClinicalTrials.gov identifier NCT00120406) evaluating a paclitaxel-coated drug-eluting stent (DES) compared to percutaneous transluminal angioplasty (PTA) for treating peripheral artery disease.
Patients were randomly assigned to primary DES or PTA. In the Japanese cohort, 27 patients (21 men; mean age 71.2±9.6 years) were randomized to PTA and 25 patients (19 men; mean age 69.8±10.2 years) to primary DES. In the non-Japanese cohort, 211 patients (131 men; mean age 67.3±10.6 years) were randomized to PTA and 211 patients (136 men; mean age 67.6±9.5 years) to primary DES. Outcome measures included event-free survival (EFS), freedom from target lesion revascularization (TLR), patency, stent fracture, and sustained clinical benefit through 2 years.
Safety and effectiveness outcomes were similar in the Japanese and non-Japanese cohorts, although the outcomes in the Japanese cohort treated with primary DES were numerically better. In the DES group, the 2-year EFS was 92.0% vs. 85.0% (p=0.61), freedom from TLR was 96.0% vs. 85.5% (p=0.55), primary patency was 80.0% vs. 74.3% (p=0.61), and clinical benefit was sustained in 88.5% vs. 80.5% of patients (p=0.31) in the Japanese and non-Japanese cohorts, respectively. Stent fractures were seen in 4 of 457 stents at 12 months: 3 in the Japanese cohort and 1 in the non-Japanese cohort.
The subgroup analysis comparing Japanese and non-Japanese patients supports the safety and effectiveness of the paclitaxel-coated DES in Japanese patients with stenotic lesions in the femoropopliteal arteries. The lack of major differences associated with ethnicity in these 2-year outcomes supports the validity and value of multinational clinical trials.
作为一项前瞻性、多中心、随机对照试验（ClinicalTrials.gov标识符NCT00120406）的一部分，报告一项亚组分析，比较日本患者和非日本患者的安全性和有效性结果。该试验评估了紫杉醇涂层药物洗脱支架（DES）与经皮腔内血管成形术（PTA）治疗外周动脉疾病的效果。
患者被随机分配至初次DES组或PTA组。在日本队列中，27例患者（21例男性；平均年龄71.2±9.6岁）被随机分配至PTA组，25例患者（19例男性；平均年龄69.8±10.2岁）被随机分配至初次DES组。在非日本队列中，211例患者（131例男性；平均年龄67.3±10.6岁）被随机分配至PTA组，211例患者（136例男性；平均年龄67.6±9.5岁）被随机分配至初次DES组。观察指标包括无事件生存期（EFS）、靶病变血运重建（TLR）率、通畅率、支架断裂情况以及2年内的持续临床获益情况。
日本队列和非日本队列的安全性和有效性结果相似，尽管接受初次DES治疗的日本队列的结果在数值上更好。在DES组中，2年EFS在日本队列和非日本队列中分别为92.0%和85.0%（p = 0.61），无TLR率分别为96.0%和85.5%（p = 0.55），初始通畅率分别为80.0%和74.3%（p = 0.61），持续临床获益的患者比例分别为88.5%和80.5%（p = 0.31）。在12个月时，457个支架中有4个发生支架断裂：日本队列中有3个，非日本队列中有1个。
比较日本患者和非日本患者的亚组分析支持紫杉醇涂层DES在患有股腘动脉狭窄病变的日本患者中的安全性和有效性。这两年的结果中缺乏与种族相关的重大差异，支持了多中心临床试验的有效性和价值。
