西洛他唑减少西洛他唑治疗股腘动脉病变的血管内治疗后的血管造影再狭窄。
Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study.
机构信息
Kansai Rosai Hospital, Cardiovascular Center, 3-1-69 Inabaso, Amagasaki, Hyogo 660-8511, Japan.
出版信息
Circulation. 2013 Jun 11;127(23):2307-15. doi: 10.1161/CIRCULATIONAHA.112.000711. Epub 2013 May 7.
BACKGROUND
It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy for femoropopliteal lesions, also reduces angiographic restenosis.
METHODS AND RESULTS
The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study investigated whether cilostazol reduces the 12-month angiographic restenosis rate after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. Two hundred patients with femoropopliteal lesions treated from March 2009 to April 2011 at 13 cardiovascular centers were randomly assigned 1:1 to receive oral aspirin with or without cilostazol. The primary end point was 12-month angiographic restenosis rate. Secondary end points were the restenosis rate on duplex ultrasound, the rate of major adverse cardiac events, and target lesion event-free survival. Researchers evaluated all follow-up data and assessed the end points in a blinded fashion. The mean lesion length and reference vessel diameter at the treated segment were 128±86 mm and 5.4±1.4 mm, respectively. The frequency of stent used was similar between groups (88% versus 90% in the cilostazol and noncilostazol group, respectively, P=0.82). During the 12-month follow-up period, 11 patients died and 152 patients (80%) had evaluable angiographic data at 12 months. The angiographic restenosis rate at 12 months was 20% (15/75) in the cilostazol group versus 49% (38/77) in the noncilostazol group (P=0.0001) by intention-to-treat analysis. The cilostazol group also had a significantly higher event-free survival at 12 months (83% versus 71%, P=0.02), although cardiovascular event rates were similar in both groups.
CONCLUSIONS
Cilostazol reduced angiographic restenosis after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00912756; and URL: https://www.umin.ac.jp. Unique identifier: UMIN000002091.
背景
西洛他唑已被证明能改善股腘动脉病变血管内治疗的临床结局，但它是否能降低血管造影再狭窄率仍不清楚。
方法和结果
西洛他唑充分治疗外周血管介入（STOP-IC）研究旨在探讨西洛他唑是否能降低股腘动脉病变经皮腔内血管成形术伴临时镍钛诺支架置入后 12 个月的血管造影再狭窄率。2009 年 3 月至 2011 年 4 月，在 13 个心血管中心，200 名股腘动脉病变患者被随机分为 1:1 组，分别接受口服阿司匹林联合或不联合西洛他唑治疗。主要终点为 12 个月的血管造影再狭窄率。次要终点为双功能超声检查的再狭窄率、主要不良心脏事件发生率和靶病变无事件生存率。研究者对所有随访数据进行评估，并以盲法评估终点。治疗段的平均病变长度和参考血管直径分别为 128±86mm 和 5.4±1.4mm。两组支架使用频率相似（西洛他唑组 88%，非西洛他唑组 90%，P=0.82）。在 12 个月的随访期间，11 例患者死亡，152 例患者（西洛他唑组 80%，非西洛他唑组 80%）在 12 个月时有可评估的血管造影数据。意向治疗分析显示，西洛他唑组 12 个月时的血管造影再狭窄率为 20%（15/75），而非西洛他唑组为 49%（38/77）（P=0.0001）。尽管两组的心血管事件发生率相似，但西洛他唑组 12 个月时的无事件生存率也明显更高（83%比 71%，P=0.02）。
结论
西洛他唑降低了股腘动脉病变经皮腔内血管成形术伴临时镍钛诺支架置入后的血管造影再狭窄率。
临床试验注册
网址：http://www.clinicaltrials.gov。唯一标识符：NCT00912756；网址：https://www.umin.ac.jp。唯一标识符：UMIN000002091。
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