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目的对因冠状动脉粥样硬化性心脏病接受择期经皮冠状动脉介入治疗(PCI)的患者,对比接受国产雷帕霉素药物洗脱支架(Firebird)和进口雷帕霉素药物洗脱支架(CypherSelect)治疗后1年的临床疗效。方法连续入选2004年1月至2006年12月于北京安贞医院接受介入治疗置入国产和进口雷帕霉素药物洗脱支架(SES)的冠心病患者2000例,根据置入支架类型,分为国产Firebird组(Firebird;1004例)和进口Cypher组(Cypher;996例)。随访1年的临床疗效。初级终点为两组患者支架术后主要心血管不良事件(MACE)的发生率,包括全因死亡、非致死性心肌梗死及靶血管重建。次级终点为1年内的支架内血栓发生率。结果 1年的随访结果显示,国产和进口雷帕霉素药物洗脱支架(SES)组的MACE发生率差异无统计学意义(17.8%比18.6%,P=0.666)。两组患者的死亡(4.7%比5.1%,P=0.649)、心肌梗死(4.2%比4.8%,P=0.493)和靶血管重建率(9.0%比8.6%,P=0.795)均相近。两组患者12个月确定/可能性支架内血栓的发生率亦差异未见统计学意义(1.1%比1.0%,P=0.841)。多因素回归分析表明,DES类型不是1年内MACE的独立预测因素。结论国产FirebirdSES和进口CypherSES在术后1年内具有相同的临床疗效和安全性。
Objective To compare the efficacy and safety of domestic and imported rapamycin-eluting stents (PCIs) in patients with coronary atherosclerotic heart disease undergoing elective percutaneous coronary intervention (PCI) CypherSelect) after 1 year of clinical efficacy. Methods A total of 2000 CHD patients with domestic and imported rapamycin-eluting stents (SES) undergoing percutaneous coronary intervention in Anzhen Hospital of Beijing from January 2004 to December 2006 were selected. According to the type of stent implantation, For the domestic Firebird group (Firebird; 1004 cases) and imported Cypher group (Cypher; 996 cases). Follow-up of 1 year clinical efficacy. The primary endpoint was the incidence of major adverse cardiovascular events (MACE) after stent surgery in both groups, including all-cause, non-fatal myocardial infarction and target revascularization. Secondary end point was the incidence of stent thrombosis within 1 year. Results The follow-up results at one year showed that there was no significant difference in the incidence of MACE between domestic and imported rapamycin-eluting stents (17.8% vs 18.6%, P = 0.666). Mortality (4.7% vs 5.1%, P = 0.649), myocardial infarction (4.2% vs. 4.8%, P = 0.493) and target vessel revascularization (9.0% vs. 8.6%, P = 0.795) were similar for both groups. The incidence of stent thrombosis was also not significantly different at 12 months in both groups (1.1% vs 1.0%, P = 0.841). Multivariate regression analysis showed that DES type was not an independent predictor of MACE within 1 year. Conclusion Domestic Firebird SES and imported CypherSES have the same clinical efficacy and safety within 1 year after operation.