雷帕霉素和紫杉醇药物洗脱支架治疗冠心病复杂病变的临床近远期疗效比较

Short and long-term therapeutic effects of rapamycin-eluting stent and paclitaxel-eluting stent in treatment of coronary disease with complicated lesions

目的比较雷帕霉素(CYPHER)和紫杉醇(TAXUS)药物洗脱支架(DES)在冠心病复杂病变中的临床近、远期疗效。方法本研究选自2002年4月至2004年6月接受雷帕霉素和紫杉醇DES治疗的冠心病患者分别611例(642处病变,共置入698个雷帕霉素支架)和450例(534处病变,共置入600个紫杉醇支架),复杂病变的种类包括长段弥漫性狭窄、慢性完全闭塞性病变、分叉病变、支架内再狭窄,以及冠状动脉开口病变和左冠状动脉主干病变。结果雷帕霉素和紫杉醇DES置入成功率分别为99.2%(606/611)和98.8%(445/450),住院期间心脏事件[死亡、急性心肌梗死、靶病变血管重建,主要不良心脏事件(MACE)]发生率分别为0.65%和1.30%(P>0.05),6～8个月随访率分别为97.5%(596/611)和96.2%(433/450),随访期间MACE发生率分别为2.3%和3.2%(P>0.05),再狭窄发生率分别为7.3%和14.0%(P>0.05),血栓形成发生率分别为0.49%和0.89%(P>0.05)。结论对于冠心病复杂性病变,雷帕霉素和紫杉醇DES均有良好的临床近、远期疗效,在再狭窄发生率方面雷帕霉素支架优于紫杉醇支架。

Objective To compare the short and long-term clinical outcomes of rapamycin （sirolimus）-eluting stent （DES） （CYPHER stent ） and paclitaxel-DES （TAXUS stent ） in treatment of coronary heart disease （CHD） patients with complicated lesions. Methods 611 CHD patients with 642 lesions, were treated with 698 CYPHER stents, and 450 sex, age, clinical data and lesion type-matched patients, with 534 lesions, were treated with 600 TAXUS stents by means of percutaneous coronary intervention. The short and long term outcomes were compared between these 2 groups. Results The success rate of stent implantation was 99.2% （606/611） and 98.8% （445/450） in the CYPHER stent and TAXUS stent groups respectfully. The overall rate of major cardiac events, including death, acute myocardial infarction （AMI） target lesion revascularization （TLR）, and major adverse cardiac event （MACE）, during hospitalization and 6-8 month＇ follow-up were 0. 65% and 2. 3% in the CYPHER stent group, not significantly different from those of the TAXUS stent group （ 1.3% and 3. 2% respectively）. The restenosis rate of the TAXUS stent group was 7.3%, a little higher than that of the CYPHER stent group （ 14% ）, but without significant difference. Conclusion CYPHER and TAXUS DES are both safe and effective in CHD patients with complicated lesions. There is an increasing tendency of restenosis rate in the TAXUS stent group in comparison with the CYPHER stent.