西洛他唑与噻氯匹定预防冠心病支架置入术后冠状动脉再狭窄的效果对比

A randomized trial of cilostazol versus ticlopidine for anti-platelet therapy after coronary artery stenting for prevention of restenosis

目的评价西洛他唑对冠状动脉支架术后再狭窄的影响。方法150例行冠状动脉支架术的患者随机分为西洛他唑组(试验组)和噻氯匹定组(对照组)。两组患者于术前48 h开始服用西洛他唑200 mg/d或噻氯匹定500 mg/d,西洛他唑组术后持续服药6个月,噻氯匹定组服药4周,并分别加用阿司匹林100 mg/d至术后6个月。出院后定期门诊随访,术后6个月复查冠状动脉造影。结果在随访中,试验组严重心脏事件发生率和严重药物副反应较对照组少。试验组和对照组在支架术后6个月造影中最小管径(2.24±1.16 mm比2.04±1.24 mm)、实际管径获得(2.73±0.45 mm比2.78±0.46 mm)、最终管径丢失(0.90±1.05 mm比1.06±1.14 mm)、丢失指数(0.34±0.40比0.38±0.40)和再狭窄率(28.0%比36.7%)差异均无统计学意义。结论西洛他唑在冠状动脉支架置入后预防急性或亚急性血栓并发症和降低晚期再狭窄率与噻氯匹定具有接近的作用,对于不能耐受噻氯匹定的患者,西洛他唑可以作为替代药物。

Objective To evaluate the efficacy and safety of cilostazol in comparison with ticolopide in the prevention of restenosis in patients with coronary stenting. Methods A total of 150 patients planed to stent implantation were randomly assigned to either cilostazol group （cilostazol 100mg twice daily, in addition to aspirin for 6 month） or to ticolopide control group （ticolopide 250 mg twice daily for 1 month, in addition to aspirin for 6 month）. Angiographic follow-up was performed at 6 months, and clinical follow-up was continued up to 2 years. The angiographic end point was the minimal luminal diameter at follow-up as determined by quantitative coronary angiography. The primary clinical end points included death from any cause, myocardial infarction, the need for target lesion revascularization and new onset of stroke. Results The mean （ ± SD） minimal luminal diameters, net lumen gain and late lumen loss at follow-up were 2.24 ± 1.16 mm, 2.73 ± 0.45 mm and 0.90 ± 1.05 mm in the cilostazol group respectively, while in the ticolopide group were 2.04 ± 1.24 mm, 2.78 ± 0.46 mm and 0.38 ±0.40 mm, respectively （all P values 〉 0.05）. Rates of restenosis （diameter of stenosis t〉50 percent） was 28.0% in cilostazol group and 36.7% in ticolopide group （P 〉 0.05）. Conclusion Aspirin plus cilostazol showed comparable antithrombotic effect as aspirin plus ticlopidine after elective coronary stenting and may serve as an alternative treatment for patients intolerable to ticlopidine.