微孔载药支架与可降解聚合物药物涂层支架治疗急性冠脉综合征的对比研究

Clinical Comparative Evaluation between Drug-loaded Microporous Stent and Biodegradable Polymer Stent for Acute Coronary Syndrome

目的:对微孔载药支架与可降解聚合物药物涂层支架治疗急性冠脉综合征(ACS)6个月的临床疗效及安全性进行对比研究。方法:采用随机、对照的研究方法,入选120例ACS住院患者,根据所置入支架分为YINYI组(n=60)和EXCEL组(n=60)。平均随访6个月;以主要不良心脏事件(MACE)、支架内再狭窄(ISR)率、直径狭窄程度和晚期管腔丢失(LLL)为研究终点,评价YINYI和EXCEL支架治疗ACS的安全性和临床效果。结果:随访期内两组MACE发生率均为0,YINYI组13例和EXCEL组10例于术后接受了定量冠状动脉造影随访。ISR发生率分别为0,直径再狭窄率分别为(6.32±5.32)%和(6.85±5.53)%,LLL分别为(-0.03±0.05)mm和(-0.03±0.07)mm,上述各项指标差异均无统计学意义(P>0.05)。结论:微孔载药支架(YINYI)与可降解聚合物药物涂层支架(EXCEL)治疗ACS至少在6个月内安全有效,二者在临床疗效及安全性方面无显著性差异。

Objective：To evaluate the safety and efficacy of the drug-loaded microporous stent and the biodegradable polymer stent in patients with Acute coronary syndrome m six months.Methods：In this random and comparative study,120 in-hospital patients with ACS were divided into YINYI group and EXCEL group by corresponding standards. The average follow-up for 6 months;The safety and efficacy of YINYI and EXCEL stent was evaluated by major adverse cardiac events （MACE）,in-stent restenosis （ISR） rate,percent diameter stenosis rate as well as late luminal loss LLL） at six months post stenting.Results： Quantitative coronary angiography （QCA） analysis were available in t3 patients in YINYI group and 10 patients in EXCEL group.In both groups.MACE was 0.ISR rates was 0.Percem diameter stenosis rate[（6.32± 5.32）% vs （6.85±5.53）%],LLL[（-0.03±0.05）mm vs （-0.03±0.07）mm],respectively. Conelusion：lt was safe and effective in the patients suffering from ACS treated with The drag-loaded microporous stent[YINYI）and the drug-eluting stent with biodegradable polymer （EXCEL） at least 6 months.The two sorts of stents can obtain satisfactory short-term clinical results in the aspects of lowering MACE,preventing ISR,reducing the LLL,and there were no significant differences between them in the aspects of safety and efficacy.