冠状动脉小血管病变患者置入生物可降解涂层药物洗脱支架后应用不同双联抗血小板治疗时长有效性及安全性分析

The application of biodegradable coated drug-eluting stents in patients with coronary small vessel disease is different efficacy and safety of dual antiplatelet therapy duration

目的探讨冠状动脉小血管置入生物可降解涂层药物洗脱支架(BP-DES)术后不同双联抗血小板治疗(DAPT)时长对患者长期临床预后的影响。方法选取I-LOVE-IT 2研究中置入BP-DES且参考血管直径<2.75 mm的1064例患者为研究对象。根据DAPT时长将患者分为6个月双抗组(n=549)与12个月双抗组(n=515)。本研究的主要终点为48个月的靶病变失败(TLF),包括心源性死亡、靶血管心肌梗死和(或)靶病变血运重建的复合终点。次要终点包括48个月的全因死亡、肯定(可能)的支架内血栓、卒中、出血学术研究联合会(BARC)定义的主要出血(BARC 3~5型)以及TLF事件独立组分组成。记录并比较两组患者的临床资料、冠状动脉造影及介入资料、终点事件。结果两组患者年龄、体质量指数及男性、吸烟史、高血压、糖尿病、高脂血症比例等比较,差异均无统计学意义(P>0.05)。两组患者靶血管病变支数,靶病变数量,靶血管位置,基线或残余SYNTAX评分,支架数量,支架长度等比较,差异均无统计学意义(P>0.05)。两组患者TLF、全因死亡、心源性死亡、心肌梗死、靶血管心肌梗死、卒中、血运重建、靶血管血运重建、BARC 3~5型出血、肯定/极可能的支架内血栓等发生率比较,差异均无统计学意义(P>0.05)。结论对于冠状动脉小血管病变置入BP-DES患者,应用6个月与12个月DAPT治疗方案对患者48个月临床结局的影响相似。

Objective To investigate the effect of different duration of dual antiplatelet therapy(DAPT)on the long-term clinical prognosis of patients after biodegradable polymer drug-eluting stents(BP-DES)implantation in coronary small vessels.Methods A total of 1064 patients with BP-DES implanted in the I-LOVE-IT 2 study and the reference vessel diameter<2.75 mm were selected as the research objects.According to the duration of DAPT,the patients were divided into 6-month dual-antibody group(n=549)and 12-month dual-antibody group(n=515).The primary end point was target lesion failure(TLF)at 48 months,a composite of cardiac death,target-vessel myocardial infarction,and/or target-lesion revascularization.Secondary end points included all-cause death at 48 months,definite(probable)stent thrombosis,stroke,major bleeding(BARC type 3 to 5)as defined by bleeding academic research consortium,and independent components of TLF events.The clinical data,coronary angiography and interventional data,and end-point events were recorded and compared between the two groups.Results There were no significant differences in age,body mass index,male sex,smoking history,proportion of hypertension,diabetes and hyperlipidemia between the two groups(P>0.05).There were no significant differences in the number of target vascular lesions,number of target lesions,location of target vessels,baseline or residual SYNTAX score,number of stents,and length of stents between the two groups(P>0.05).There were no significant differences in the incidences of TLF,all-cause death,cardiac death,myocardial infarction,target vessel myocardial infarction,stroke,revascularization,target vessel revascularization,BARC type 3-5 bleeding,and sure/very likely stent thrombosis between the two groups(P>0.05).Conclusion The effect of 6-month versus 12-month DAPT on 48-month outcomes was similar for patients with BP-DES implantation for coronary small vessel lesions.