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目的:探讨国产无聚合物紫杉醇涂层支架(YINYI)和可降解聚合物雷帕霉素涂层支架(EXCEL)治疗冠心病,预防心血管事件的有效性和安全性。方法:167例符合冠状动脉介入手术指征的冠状动脉病变患者被随机分为YINYI组和EXCEL组,分别接受YINYI和EXCEL治疗。12个月临床随访,观察2组支架内血栓形成事件、MACE、全因死亡率及再入院情况。结果:YINYI组82例,置入YINYI 160枚,EXCEL组85例,置入EXCEL 188枚。2组患者平均靶病变长度分别为(22.31±11.32)mm和(22.25±10.98)mm,置入支架长度分别为(19.78±4.76)mm和(20.27±5.05)mm,差异无统计学意义(P>0.05)。12个月临床随访观察,2组无晚期肯定支架血栓形成事件,总支架血栓事件YINYI组少于EXCEL组(1.26%:3.70%,P>0.05),但无显著性差异。2组比较全因死亡率(2.53%:3.70%,P>0.05)、MACE(6.33%:6.17%,P>0.05)、再次住院率(16.46%:20.99%,P>0.05),其中冠心病住院率(7.59%:7.40%,P>0.05),非冠心病住院率(8.86%:13.58,P>0.05),差异均无统计学意义。结论:国产YINYI治疗冠心病,预防心血管事件与EXCEL相当,二者均用有良好的有效性和安全性。
OBJECTIVE: To investigate the efficacy and safety of a domestic polymer-free paclitaxel-coated stent (YINYI) and a degradable polymer-coated rapamycin-eluting stent (EXCEL) in the treatment of coronary heart disease and cardiovascular events. METHODS: One hundred and sixty-seven patients with coronary artery lesions eligible for coronary intervention were randomly divided into YINYI group and EXCEL group, and received YINYI and EXCEL respectively. The patients were followed up for 12 months. The incidence of stent thrombosis, MACE, all-cause mortality and rehospitalization were observed in two groups. Results: YINYI group consisted of 82 cases with 160 YINYI and 85 EXCEL groups with 188 EXCELs. The average length of target lesions in the two groups was (22.31 ± 11.32) mm and (22.25 ± 10.98) mm, respectively, and the stent length was (19.78 ± 4.76) mm and (20.27 ± 5.05) mm, respectively, with no significant difference > 0.05). The 12-month clinical follow-up observation showed that there was no late stent thrombosis in two groups. The total stent thrombosis was less in YINYI group than in EXCEL group (1.26%: 3.70%, P> 0.05), but there was no significant difference. The rates of all-cause mortality (2.53% vs. 3.70%, P> 0.05), MACE (6.33% vs 6.17%, P> 0.05) and hospitalization again (16.46% vs 20.99%, P> The hospitalization rate was 7.59% (7.40%, P> 0.05). The hospitalization rate of non-CHD was 8.86% (13.58, P> 0.05). There was no significant difference between the two groups. Conclusion: Domestic YINYI treatment of coronary heart disease, prevention of cardiovascular events and EXCEL quite, both with good effectiveness and safety.