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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 incidence and clinical prognosis of stent thrombosis (ST) after the implantation of the second-generation cobalt-chromium alloy platform drug-eluting stent (DES) The promotion and application of clinical evidence. METHODS: This study analyzed the 3-year cumulative incidence of ST in 5,084 patients with DES on Firebird 2 cobalt-chromium alloy platform in the FOCUS study, a large prospective, multinational, multinational registry study, as well as the clinical characteristics of patients with ST, The use of dual antiplatelet therapy (DAPT), treatment and prognosis after ST have occurred. Results: Among 5 084 patients, the cumulative 3-year cumulative rate of ST was 0.67% (35 cases), including 8 cases of acute ST, 11 cases of subacute ST, 8 cases of advanced stage ST and 8 cases of late stage ST. Twenty-eight of them were treated with recanalization or revascularization after thrombolytic therapy, and the remaining seven patients died with a mortality rate of 20.6%. Of the 35 patients with ST, DAPT was performed in at least 12 months in 3 patients except DAPT in early stage and clopidogrel in 1 patient. CONCLUSION: The 3-year follow-up results of FOCUS study showed that the incidence of ST was less than 1% after DES implantation of the second-generation Firebird 2 cobalt-chromium alloy platform, which provided the basis for the clinical application of this stent.