Coronary stent restenosis in patients treated with cilostazol
Coronary stent restenosis in patients treated with cilostazol
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DOI：
10.1161/circulationaha.104.530097
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发表时间：
2005-11-01
期刊：
影响因子：
37.8
通讯作者：
Weintraub, WS
中科院分区：
文献类型：
--
作者：
Douglas, JS;Holmes, DR;Weintraub, WS
背景：冠状动脉支架术后再狭窄仍然是一个重要的临床问题。我们进行了一项随机、双盲、安慰剂对照试验，以确定抑制冠状动脉内膜增殖的药物西洛他唑是否会减少冠状动脉支架植入术后患者的再狭窄。方法和结果：我们将705名成功植入冠状动脉支架的患者分配到在阿司匹林的基础上服用西洛他唑100 mg，2次/d或安慰剂6个月；所有患者每天服用氯吡格雷75 mg，持续30天。术后6个月行定量冠状动脉造影术判定再狭窄情况。接受西洛他唑治疗的患者在6个月时分析段(支架加5 mm边界)的最小内径为1.77 mm，而安慰剂组为1.62 mm(P=0.01)。西洛他唑组和安慰剂组的再狭窄发生率分别为22.0%和34.5%(P=0.002)，相对风险降低36%。再狭窄率在接受西洛他唑治疗的糖尿病患者(17.7%比37.7%，P=0.001)、小血管患者(23.6%比35.2%，P=0.02)、长病变患者(29.9%比46.6%，P=0.04)和冠状动脉左前降支病变患者(19.3%比39.8%，P=0.001)中显著降低。两组在出血、再住院、靶血管重建、心肌梗死和死亡方面无差异。结论：与安慰剂组相比，西洛他唑组患者的最小管腔直径显著增大，二次再狭窄率显著降低。这些有利的效果在再狭窄的高危患者中表现得尤为明显。
Background: Restenosis after implantation of coronary artery stents remains a significant clinical problem. We undertook a randomized, double-blind, placebo-controlled trial to determine whether cilostazol, a drug that suppresses intimal proliferation, would reduce renarrowing in patients after stent implantation in native coronary arteries.Methods and Results: We assigned 705 patients who had successful coronary stent implantation to receive, in addition to aspirin, cilostazol 100 mg BID or placebo for 6 months; clopidogrel 75 mg daily was administered to all patients for 30 days. Restenosis was determined by quantitative coronary angiography at 6 months. The minimal luminal diameter at 6 months for cilostazol-treated patients was 1.77 mm for the analysis segment (stent plus 5-mm borders) compared with 1.62 mm in the placebo group (P = 0.01). Restenosis, defined as >= 50% narrowing, occurred in 22.0% of patients in the cilostazol group and in 34.5% of the placebo group (P = 0.002), a 36% relative risk reduction. Restenosis was significantly lower in cilostazol-treated diabetics (17.7% versus 37.7%, P = 0.01) and in those with small vessels (23.6% versus 35.2%, P = 0.02), long lesions (29.9% versus 46.6%, P = 0.04), and left anterior descending coronary artery site (19.3% versus 39.8%, P = 0.001). There was no difference in bleeding, rehospitalization, target-vessel revascularization, myocardial infarction, or death.Conclusions: Treatment with the drug cilostazol resulted in a significantly larger minimal luminal diameter and a significantly lower binary restenosis rate compared with placebo-treated patients. These favorable effects were apparent in patients at high risk for restenosis.