载雷帕霉素可降解聚合物涂层支架治疗冠心病的临床观察

目的以Cypher支架为标准,评价载雷帕霉素可降解聚合物涂层支架(EXCEL支架)治疗冠心病(CAD)的安全性和临床效果。方法采用前瞻性、非随机对比研究方法,根据入选和剔除标准入选60例CAD患者,根据所置入支架分为EXCEL组(n=32)和Cypher组(n=28);相同方法进行冠状动脉造影(CAG)和支架置入;以6个月主要不良心脏事件(MACE)、再狭窄率、直径狭窄程度和晚期管腔丢失(LLL)为研究终点评价EXCEL支架治疗CAD的安全性和临床效果。结果平均随访(6.04±2.12)个月,两组MACE发生率均为0;EXCEL组27例(84.38%)和Cypher组10例(35.71%)于术后平均(6.04±2.12)个月接受了定量冠状动脉造影随访。各组再狭窄率均为0;直径再狭窄率分别为(5.98±5.52)%和(5.21±6.3)%,LLL分别为-(0.02±0.09)mm和-(0.01±0.07)mm,上述各项指标差异均无统计学意义(P>0.05)。两组均未发现与雷帕霉素及其聚合物相关的不良反应。结论EXCEL支架治疗CAD安全有效。在降低主要心脏不良事件、预防再狭窄和LLL方面可获得与Cypher支架同样满意的临床效果。

Safety and efficacy comparison between rapamycin-eluting stent with biodegradable polymer or permanent polymer in patients with coronary artery disease

OBJECTIVE: To evaluate the safety and efficacy of rapamycin-eluting stent with biodegradable polymer (EXCEL) or permanent polymer (Cypher) in patients with coronary artery disease (CAD). METHODS: In this prospective, non-random and comparative study, 60 patients with CAD were divided into EXCEL group (n = 32) and Cypher group (n = 28). The coronary angiography (CAG) and stenting procedure were identical. The safety and efficacy of EXCEL stent was evaluated by major adverse cardiac events (MACE), restenosis rate and percent diameter stenosis rate as well as late luminal loss (LLL) at six months post stenting. RESULTS: During follow-up (mean: 6.04 +/- 2.12 months), there was no MACE in the two groups. Quantitative coronary angiography (QCA) data at 6.0 +/- 2.1 months post stenting were available in 27 patients (84.38%) in EXCEL group and 10 patients (35.71%) in Cypher group. Restenosis rate was zero in both groups. Percent diameter stenosis rate (5.98% +/- 5.52% vs. 5.21% +/- 6.3%) and LLL (-0.02 +/- 0.09 mm vs. -0.01 +/- 0.07 mm) were similar between the 2 groups. CONCLUSIONS: EXCEL stent was safe for the treatment of CAD and comparable as Cypher stent in preventing MACE and restenosis at 6 months post stenting.