冠心病患者应用紫杉醇与国产雷帕霉素洗脱支架的随机对照研究

A Randomized Comparison Between Paclitaxel-Eluting Stents and Rapamycin-Eluting Stents for Patients With Coronary Artery Diseases

目的:观察冠心病患者应用雷帕霉素洗脱支架与紫杉醇洗脱支架后临床不良心血管事件的发生率。方法:本研究为随机开放平行对照研究,共入选患者168例,雷帕霉素支架组83例,紫杉醇支架组85例。两组患者在年龄,性别组成,吸烟比例,糖尿病比例,血压水平,总胆固醇水平,冠状动脉病变支数,冠状动脉病变积分(Gensini法),左心室射血分数均无统计学上的差异。术后严格要求患者服用阿司匹林和噻氯匹定或氯比格雷9个月。通过门诊或电话随访术后患者临床不良心血管事件的发生率,部分患者进行了冠状动脉造影复查。结果:平均随访10.6个月,失访患者3例(包括2例雷帕霉素支架组患者与1例紫杉醇支架组患者),失访率为1.79%。在随访的81例雷帕霉素支架组共7例(8.64%)发生了临床不良心血管事件。在随访到的84例紫杉醇支架组8例(9.52%)患者发生了不良心血管事件。以上2组患者不良心血管事件发生率差异无统计学意义(卡方检验P>0.05)。雷帕霉素支架组冠状动脉造影再狭窄率为200%(3/15),紫杉醇支架组冠状动脉造影再狭窄率为25%(6/24),两组之间无统计学差异(P>0.05)。结论:短期临床随访结果表明,冠心病患者应用雷帕霉素洗脱支架与紫杉醇洗脱支架临床心血管事件的发生率较低,两组无统计学差异。

Objective: To observe the difference of cardiovascular event occurrence rate between patients implanted with sirolimus-elu-ting stents and paclitaxel-eluting stents. Method: A randomized, opened, and paralleled study enrolled 168 patients,83 in rapamycin-eluting stents group and 85 in paclitaxel-eluting stents group. There were no differences in age, gender, smoking, diabetes, blood pressure, total cholesterol, coronary arteries, and left ventricular eject fraction between the two groups. Fully antiplatelet therapy was performed for 9 months after percutaneous coronary intervention. Follow-up was done by telephone or interview at clinic. A small proportion of patients was followed up by angiography. Results: One hundred six-five patients were followed up for average 10. 6 months, with 3 patients (1. 79% ) lost to follow up, including 2 in rapamycin-eluting stents group and 1 in paclitaxel-eluting stents group. Clinical cardiovascular events occurred in 7 in rapamycin-eluting stents, and 8 in paclitaxel-eluting stent groups. There was no difference of cardiovascular event occurrence rate between the two groups (p >0. 05) . The restenosis rates of rapamycin-eluting stent and paclitaxel-eluting stent groups were 20% (3/15) and 25% (6/24) , respectively. There were no difference between the two groups (p >0. 05). Conclusion: Short-term follow-up suggested that there is a low cardiovascular event occurrence rate in both rapamycin-eluting stent group and paclitaxel-eluting stent group, no statistical difference between the groups. Coronary angiography follow-up revealed no difference in restenosis rate between the groups.