西罗莫司洗脱支架和Pixel支架治疗冠状动脉小血管病变的比较

Comparative study of clinical and angiographic follow-up of sirolimus-eluting stent and Pixel stent for treatment of coronary small vessel disease

目的对比研究西罗莫司洗脱支架(CypherTM支架)和Pixel支架治疗冠状动脉小血管病变的安全性及疗效。方法将2003年3月至2005年1月在我院住院的67例小血管病变患者随机分成A、B两组,A组34例接受CypherTM支架治疗,B组33例接受Pixel支架治疗。比较分析两组的手术成功率、并发症发生率、心脏不良事件发生率、再狭窄率及晚期管腔丢失等指标。结果两组支架置入术的成功率均为100%,无残余狭窄或残余狭窄<10%,无任何并发症。A组有30例、B组有29例患者在术后约9个月复查了定量冠状动脉造影。随访期间,A组中有2例出现支架内再狭窄导致临床心绞痛复发;B组有7例复发心绞痛,其中6例经冠状动脉造影证实为支架内再狭窄所致;两组均无一例死亡。A组的造影再狭窄率为6.7%,B组为20.7%(P<0.05);A组的晚期管腔丢失为0.19±0.58mm,B组为0.63±0.61mm(P<0.01);A组的靶血管再次血运重建率为6.7%,B组为20.7%(P<0.05)。结论CypherTM支架和Pixel支架治疗小血管病变均安全、有效,但CypherTM支架的远期疗效明显优于Pixel支架。

Objective To compare the safety and efficacy of sirolimus-eluting stents （SES） and Pixel stents （PS） for treatment of coronary small vessel disease. Methods From March 2003 to January 2005, 67 patients with coronary small vessel disease were randomly divided into two groups： group A （ n = 34） and group B （ n = 33 ）. Group A was treated with SES and group B with PS. The procedural success rate, major adverse cardiac events, restenosis rate and late lumen loss were compared between two groups. Results Procedural success rate in beth groups was 100% without remained stenosis and cardiac complications. There were 30 patients in group A and 29 in group B whose quantitative coronary angiography was obtained 9 months after the procedure. Two patients in group A had recurrent angina because of in-stent restenosis, and 6 out of 7 patients with the angina in group B had angiographic evidence of in-stent restenosis. No death occurred in beth groups during clinical follow-up. Angiographic restenosis rate was 6.7% in group A and 20.7% in group B （ P 〈 0.05）. Late lumen loss was 0.19 ± 0.58 mm in group A and 0.63 ± 0.61 mm in group B （ P 〈 0.01 ）. The rate of target vessel revascularization 6.7 % in group A and 20.7 % in group B （ P 〈 0.05 ）. Conclusion Both SES and PS are safe and effective for the treatment of coronary small vessel disease, but the long-term efficacy of SES is much more superior than that of PS.