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目的评价国产雷帕霉素洗脱支架(SKS)在ST段抬高型急性心肌梗死(AMI)直接经皮冠状动脉介入治疗(PCI)中应用的安全性和有效性。方法2005年1月至2006年3月期间在复旦大学附属中山医院行直接PCI的204例ST段抬高型AMI患者中,共143例接受国产SKS (Firebird支架)或BMS植入的患者纳入本研究。其中,植入国产SES者74例,植人BMS者69例。对两组患者术后30天和180天的主要心血管不良事件(MACE)(包括死亡、非致死性再梗和靶血管再次血运重建[TVR])进行随访和对比分析。计量资料数据以student’s非配对t检验比较组间差别,计数资料数据以Fisher’s检验比较组间差别。采用COX回归比例风险模型对不良事件的发生进行多因素分析。以P<0.05为差异具有统计学意义。结果国产SES组和BMS组的手术成功率无统计学意义(94.6% vs 94.2%,P=1.0)。术后30 d内,国产SES组和BMS组的MACE发生率无统计学意义(5.4% vs 11.6%,P=0.23),BMS组发生1例冠脉造影证实的早期支架内血栓而国产SES无1例发生(0 vs 1.4%,P=0.48)。术后180 d随访,国产SES植入较BMS植入能明显减少MACE的发生(6.8% vs 20.3%,相对危险比为0.32,95%可信限为0.11～0.88,P=0.03),这主要归因于SES组TVR的显著降低(0 vs 14.5%,P<0.001)。术后30 d至180 d,两组无1例发生晚期支架内血栓形成。结论国产SES应用于ST段抬高型AMI具有良好的安全性,与传统的BMS相比,并不增加支架内血栓的发生率,而且能明显减少AMI患者的TVR发生率,改善患者的远期预后。
Objective To evaluate the safety and efficacy of domestic rapamycin eluting stents (SKS) in the treatment of patients with ST-elevation acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI). METHODS: From January 2005 to March 2006, 204 patients with ST-segment elevation AMI undergoing direct PCI at Zhongshan Hospital Affiliated to Fudan University were enrolled in this study. A total of 143 patients undergoing native SKS (Firebird Stent) or BMS implantation the study. Among them, 74 cases of SES were implanted and 69 cases were BMS. Follow-up and comparative analyzes of major cardiovascular adverse events (MACE), including death, nonfatal re-infarction, and target revascularization of blood vessels (TARRs) at 30 days and 180 days after surgery were performed in both groups. The data of the measurement data were compared with the Student’s unpaired t-test to compare the difference between the groups. The data of the count data were compared with Fisher’s test to compare the difference between the groups. The COX regression proportional hazard model was used to perform multivariate analysis of the occurrence of adverse events. P <0.05 for the difference was statistically significant. Results The success rate of surgery in domestic SES group and BMS group was not statistically significant (94.6% vs 94.2%, P = 1.0). Within 30 days after operation, the incidence of MACE in domestic SES group and BMS group was not statistically significant (5.4% vs 11.6%, P = 0.23), and one case of early stent thrombosis confirmed by coronary angiography in BMS group and no SES One case occurred (0 vs 1.4%, P = 0.48). Postoperative 180-day follow-up, home-made SES implants significantly reduced the incidence of MACE compared with BMS implants (6.8% vs 20.3%, relative risk 0.32 to 95% confidence interval 0.11 to 0.88, P = 0.03) Due to a significant decrease in TVR in the SES group (0 vs 14.5%, P <0.001). Between the 30th and 180th postoperative days, no stent thrombosis occurred in either group. Conclusion The application of domestic SES in ST-segment elevation AMI has good safety. Compared with traditional BMS, domestic SES does not increase the incidence of stent thrombosis, and can significantly reduce the incidence of TVR in patients with AMI and improve the long-term Prognosis.