两种国产西罗莫司洗脱支架治疗ST段抬高型心肌梗死患者的疗效和安全性研究

Efficacy and safety of two kinds of homemade sirolimus-eluting stents for treatment of acute ST segment elevation myocardial infarction

目的比较两种国产西罗莫司洗脱支架（Excel与Firebird）对急性ST段抬高型心肌梗死（STEMI）患者行直接经皮冠状动脉介入治疗（PCI）的有效性和安全性。方法入选我院急性STEMI患者249例，根据植入支架类型，随机分为Excel支架组136例（54．6％）和Firebird支架组113例（45．4％）。随访6～24个月，平均12个月行定量冠状动脉造影复查。比较两组患者手术即刻成功率，术后住院及随访过程中主要不良心脏事件（包括心原性死亡、再发心肌梗死和靶病变血运重建）发生率及晚期管腔丢失、支架再狭窄、支架内血栓发生率。结果两组患者术前临床基线特征及冠状动脉病变情况、直接PCI术后即刻情况差异均无统计学意义（P〉0．05）；术后平均12个月随访中，两组患者死亡分别为2例（1．47％）与1例（0．88％），无心原性死亡。非致死心肌梗死分别为1例（0．74％）与1例（O．88％），靶血管再次血运重建分别为2例（1．47％）与2例（1．77％），差异无统计学意义（均P〉0．05）。定量冠状动脉造影随访两组支架内最小管腔内径、节段内最小管腔内径、支架内晚期管腔丢失、节段内晚期管腔丢失，差异无统计学意义（均P〉0．05）；支架内再狭窄、节段内再狭窄、支架内血栓形成的发生率差异亦无统计学意义（均P〉O．05）。结论STEMI患者直接PCI应用两种国产西罗莫司洗脱支架均有效、安全。

Objective To compare the efficacy and safety of two kinds of homemade sirolimus- eluting stents （Firebird and Excel） for treatment of acute ST segment elevation myocardial infarction （STEMI） in patients who underwent percutaneous coronary intervention （PCI）. Methods The 249 consecutive patients with STEMI who underwent PCI were randomly divided into two groups： Excel group （n=136） and Firebird group （n=113）. They were followed up for 6-24 months, and coronary angiography was reviewed average 12 months later. The primary endpoints were major adverse cardiac events, including death, reinfarction and target vessel revascularization. The second endpoints included late luminal loss and restenosis 12 months after treatment. Results There were no significant differences in baseline data, coronary arterial lesion before operation, and immediateness condition after PCI between the two groups （all P〉0.05）. Within follow-up, there were 2 （1.47%） death cases and 1 （0.88%） death case, 1 （0. 74%） and 1 （0. 88%） nonfatal myocardial infarction case, 2 （1.47%） and 2 （1.77%） target vessel revascularization cases in the two groups respectively （all P〉0.05）. There were no significant differences in late luminal loss of in-stent and in-segment, the rates of in-stent restenosis, in-segment restenosis and stent thrombosis, the in-stent minimal lumen diameter and in-segment minimal lumen diameter between the two groups （all P〉 0.05）.Conclusions The two kinds of homemade sirolimus-eluting stents may have similar efficacy and safety in patients with STEMI treated with primary PCI.