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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。
Objective To evaluate the safety and clinical efficacy of rapamycin-degradable polymer-coated stent (EXCEL) in the treatment of coronary heart disease (CAD) with the Cypher stent as the standard. Methods Sixty patients with CAD were enrolled in the prospective, non-randomized comparative study. According to the inclusion criteria, EXCEL group (n = 32) and Cypher group (n = 28) Angiography (CAG) and stenting were performed. The safety and clinical efficacy of EXCEL stent in the treatment of CAD were evaluated at six-month major adverse cardiac events (MACE), restenosis rate, diameter stenosis and late luminal loss (LLL) . Results The average follow-up time was (6.04 ± 2.12) months. The incidence of MACE was 0 in both groups. 27 cases (84.38%) in EXCEL group and 10 cases (35.71%) in Cypher group received an average of 6.04 ± 2.12 months Quantitative coronary angiography follow-up. The restenosis rate was 0 in each group. The diameter restenosis rates were (5.98 ± 5.52)% and (5.21 ± 6.3)%, respectively, and the LLL were -0.02 ± 0.09 mm and -0.01 ± 0.07 mm respectively. There was no significant difference in index (P> 0.05). No adverse reactions to rapamycin and its polymers were found in either group. Conclusion EXCEL stent is safe and effective in treating CAD. The same clinical benefit as Cypher’s stent is available in reducing major adverse cardiac events, preventing restenosis, and LLL.