国产BuMA支架术后支架血栓及主要临床事件随访分析

Stent thrombosis and major clinical events after Bu MA coronary stent implantation

目的探讨植入国产生物降解药物涂层冠状动脉Bu MA支架治疗冠心病的远期安全性及有效性。方法选择同期植入Bu MA支架及Resolute支架的冠心病患者分别作为观察组(440例)和对照组(460例),2组临床基线情况、冠脉造影(CAG)病变情况及经皮冠脉介入治疗(PCI)相关指标均无明显差别。对患者进行平均(24±4)个月随访,随访主要终点事件为发生明确的或很可能的支架血栓(ST);次要终点事件为主要心脏不良事件(MACEs),包括再发心绞痛、急性非致死性心肌梗死、死亡、靶血管血运重建(TVR)的复合终点;其他终点事件为全因死亡、心源性死亡、心肌梗死(MI)、靶病变血运重建(TLR)、非靶血管血运重建及卒中。观察组失访5例,对照组失访26例。结果观察组435例患者共植入615枚支架,对照组434例患者共植入614枚支架,2组均平均植入1.41枚/例。2组主要终点[1.4%(6/435)vs 1.8%(8/434),χ2=0.087]、次要终点[12.3%(54/435)vs 10.8%(47/434),χ2=0.524]及其他终点事件发生率的差异均无统计学意义。结论国产Bu MA支架具有良好的远期安全性及有效性。

Objective To investigate the long-term safety and efficacy of the domestic biodegradable drug-eluting cor？onary stents （BuMA） in treating coronary heart disease （CHD）. Methods Patients （n=440） who received BUMA stents were designated as observation group while patients （n=460） received Resolutestents were designated as control group. The base？line clinical characteristics, extend of pathological change shown by Coronary Arteriography （CAG）,the procedure of percu？taneous coronary intervention were similar between these two groups. The patients were followed up for a mean of 24 ＆#177; 4 months;the primary endpoint was the occurrence of definite or probable stent thrombosis;secondary endpoint was major ad？verse cardiac events （MACEs） including complex end such as recurrent angina, acute non-fatal myocardial infarction, death, target vessel revascularization （TVR）; other endpoints include all- cause mortality, cardiac death, myocardial infarc？tion （MI）, target lesion revascularization （TLR）, non-target vessel revascularization and stroke. Some patients were lost dur？ing follow up, which include 5 in observation group and 26 in control group. Results Patients in observation groups were in？serted with 615 stents while patients in control group were implanted with 614 stents, both groups with average of implanting 1.41 stent/case. There are no statistical significance differences in the primary endpoint [1.4%（6/435） vs 1.8%（8/434）, χ2=0.087], secondary endpoint [12.3%（54/435） vs 10.8%（47/434）,χ2=0.524] and other endpoints between the two groups. Con？clusion These data suggest that domestic biodegradable drug-eluting coronary stents （BuMA） are with good long-term safe？ty and efficacy.