ST段抬高心肌梗死应用国产西罗莫司洗脱支架与金属裸支架的对比研究

目的评估在ST段抬高心肌梗死(STEMI)患者应用国产西罗莫司洗脱支架的安全性和有效性。方法将1年内连续入选STEMI的患者随机分为国产西罗莫司洗脱(火鸟)支架组或金属裸支架(BMS)组。对所有患者连续临床随访6个月,术后6个月常规行冠状动脉造影。试验主要终点是术后6个月靶病变区晚期管腔丢失(LLL),次要终点包括支架内血栓发生率和主要心脏不良事件(MACE)。结果试验前6个月共入选85例患者。国产西罗莫司(火鸟)支架组42例,平均年龄58·1岁。BMS组43例,平均年龄59·8岁。两组6个月血管造影随访率分别为47·6%和44·2%。6个月随访结果显示,国产西罗莫司(火鸟)支架组死亡率、靶血管重建率(TVR)和MACE分别为2·4%,0%和2·4%,BMS组相应为4·7%,31·6%和25·6%(P<0·05)。BMS组有1例发生支架内亚急性血栓。定量冠状动脉造影结果显示,国产西罗莫司(火鸟)支架组支架内平均LLL为0·18mm,BMS组为0·72mm。结论与BMS比较,国产西罗莫司(火鸟)支架能够有效降低STEMI患者6个月死亡率、TVR和MACE发生率,其急性或亚急性支架血栓发生率低。

Initial results of home-made sirolimus eluting stent (Firebird DES stent) versus bare metal stent in ST segment elevation myocardial infarction (FIBISTEMI Trial)

Objective To assess the safety and efficacy of home-made sirolimus eluting stent in China (Firebird stent) versus bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). Methods Patients with STEMI were enrolled consecutively during one year period and were randomized into the Firebird stent group or the BMS group. All patients underwent clinical and angiographic follow-up after primary stenting. The primary endpoint of the study was in-lesion late lumen loss (LLL) at 6 months, and the secondary endpoints included stent thrombosis and major adverse cardiac events at 6 months. Results During the first 6 months of the study, a total of 85 patients were enrolled and were randomized into the Firebird stent group (n=42, average age=58.1 years old) or the BMS group (n=43, average age=59.8 years old). Six-month angiographic follow-up were completed in 47.6% and 44.2% of the patients in the Firebird stent group and BMS group respectively. At 6-month follow-up, the mortality, target vessel revascularization (TVR) and MACE were 2.4%, 0% and 2.4% in the Firebird stent group compared with 4.7%, 31.6% and 25.6% in the BMS group (P<0.05). Sub-acute thrombosis occurred in 1 patient in the BMS group. The mean LLL were 0.18 mm in the Firebird stent group and 0.72 mm in the BMS group. Conclusion Implantation of home-made sirdimus eluting stent for STEMI showed reduction in mortality, TVR and MACE at 6 months with low incidence of acute/sub-acute stent thrombosis compared with BMS.