摘要
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 assess the safety and efficacy of domestic sirolimus-eluting stent （SES） compared with bare metal stent （BMS） in the primary pemutaneous coronary intervention （PCI） for patients with ST-segment elevation AMI in a real-world scenario. Method From January 2005 to March 2006, a total of 143 patient with ST-segment elevation AMI were enrolled in this study, and all of them underwent primary percutaneous coronary intervention （PCI）. Among the 143 patients, 74 were treated with domestic SESs （Firebird stent） and 69 with BMSs. The incidence of major adverse cardiovascular events （MACE： death, reinfarction, and target vessel revascularization [TVR] ） was evaluated at 30 days and 180 days. Continuous variables were compared using Student＇s unpaired t test. Categorical variables were compared using Fisher＇ s test. Cox proportional hazard survival models were used to assess risk reduction of adverse events. P value 〈 0.05 was considered statistically significant. Results Procedural success rates of two groups were approximate （94.6% in domestic SES group vs. 94.2% in BMS group, P = 1.0）. The incidence of short-term adverse events was also similar between domestic SES group and BMS group （30-day rate of MACE： 5.4% vs. 11.6%, P = 0.23）. Angiographically documented stent thrombosis （early thrombosis） was not diagnosed in any patient in the domestic SES group and it occurred in 1.4% of patients with BMS implanted （P = 0.48）. After 180-day follow-up, domestic SES implantation significantly reduced the incidence of MACE （6.8 % vs. 20.3 %, hazard ratio 0. 32 [ 95 % confidence interval 0.11 to 0.88], P=0.03）, mainly due to a marked reduction in TVR （0 vs. 14.5%, P〈0.001）. There was no new onset of angiographically documented stentt thrombosis between 30 and 180 days in both groups. Conclusions Compared with conventional BMS, utilization of domestic SES in the setting of primary PCI for ST- segment elevation AMI was not associated with an increased risk of stent thrombosis. Moreover, it improved the long-term clinical outcome by reducing the incidence of TVR.
出处
《中华急诊医学杂志》
CAS
CSCD
2007年第11期1175-1179,共5页
Chinese Journal of Emergency Medicine
基金
上海市科委重大科研计划项目课题(05DZ19501)
国家重点基础研究发展计划资助项目(2006CB503803)
关键词
急性心肌梗死
药物洗脱支架
金属裸支架
经皮冠状动脉介入治疗
Acute myocardial infarction
Drug-eluting stentt
Bare metal stentt
Percutaneous coronary intervention
