国产钴铬合金平台药物洗脱支架植入术后支架内血栓形成的临床分析

Clinical analysis of stent thrombosis after implantation of domestic cobalt-chromium drug-eluting stents

目的:分析国产第二代钴铬合金平台药物洗脱支架(drug-eluting stent,DES)植入术后支架内血栓(stent thrombosis,ST)的发生情况和临床预后,从而为国产第二代DES的推广应用提供临床证据。方法:该研究分析了大型前瞻性、国际多中心注册研究——FOCUS研究中5 084例植入Firebird 2钴铬合金平台DES患者的3年期ST累积发生率,以及ST发生患者的临床特征、双联抗血小板治疗(dual antiplatelet therapy,DAPT)使用情况、ST发生后的处理及预后等。结果:5 084例入选患者中,ST的3年累积发生率为0.67%(35例),包括急性ST 8例,亚急性ST 11例,晚期ST 8例及迟发晚期ST 8例。其中28例再行介入治疗或溶栓治疗后血管再通,其余7例死亡,病死率为20.6%。35例ST患者中,除3例早期停服DAPT、1例仅服用氯吡格雷外,其他患者均接受DAPT治疗至少12个月。结论:FOCUS研究3年随访结果显示国产第二代Firebird 2钴铬合金平台DES植入术后ST的发生率低于1%,为该支架的临床应用提供了依据。

Objective：To analyze the occurence and prognosis of stent thrombosis（ST）after implantation of the Firebird 2cobalt-chromium drug-eluting stent（DES）so as to provide abundant clinical evidence for the wide application of domestic second-generation drug-eluting stents.Methods：This study retrospectively analyzed 5 084 DES patients on the Firebird 2cobalt-chromium alloy platform during the 3-year follow-up in the large-scale,international,multicenter FOCUS registry.Three-year cumulative incidence of ST was reported.The clinical features of ST patients,duration of dual antiplatelet therapy（DAPT）,and the treatment and as prognosis of ST were the main focuses of this study.Results： The 3-year cumulative incidence of ST was 0.67%（35cases）,including 8 cases of acute ST,11 cases of subacute ST,8 cases of late ST and 8cases of very late ST.Among them,28 patients of ST were recovered after re-intervention or thrombolysis,while 7patients were died because of treatment failure.The mortality of ST patients was 20.6%.All ST patients were treated with DAPT for at least 12 months except for 3 patients who had stopped taking DAPT and 1 patient who took clopidegrel only.Conclusions：The 3-year follow-up FOCUS study shows that,the cumulative incidence of ST is less than 1% after DES implantation on the domestic second-generation Firebird 2 cobalt-chromium alloy platform,providing reliable safety evidence for the clinical application of Firebird 2 stents.