背景:比较第一代吸收生物可吸收血管支架(BVS)(雅培血管,圣克拉拉,CA,USA)使用药物洗脱支架的3年主要不良心脏事件和支架血栓形成的发生率中等但显着增加,3年后不良事件减少。
目的:本研究的目的是评估接受至少一种吸收BVS治疗并纳入FRANCEABSORB注册的患者的5年结局。
方法:在法国接受吸收BVS治疗的所有患者均被前瞻性纳入全国性的大型多中心注册。主要疗效结果是5年主要心脏不良事件的发生。次要疗效结果是5年靶血管血运重建率和明确/可能的支架血栓形成率。
结果:在2014年9月至2016年4月之间,86个中心纳入了2,070名患者(平均年龄55±11岁;80%为男性;49%为急性冠脉综合征)。1-的比率,3年和5年主要心脏不良事件为3.9%,9.4%和12.1%,分别(包括2.5%的心源性死亡和10.4%的靶血管血运重建)。通过多变量分析,糖尿病,口服抗凝药,使用多个AbsorbBVSs和使用2.5mm直径的吸收式BVS与5年主要心脏不良事件相关.1-的比率,3年和5年明确/可能的支架血栓形成为1.5%,3.1%和3.6%,分别。通过多变量分析,年龄较大,糖尿病,出院时抗凝和使用2.5mm直径吸收BVS与5年支架血栓形成相关.
结论:吸收BVS植入与1年主要不良心脏事件的低发生率相关,在3年的随访中显著增加。3年后支架血栓形成和主要不良心脏事件的发生率明显下降。
BACKGROUND: Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years.
OBJECTIVE: The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry.
METHODS: All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis.
RESULTS: Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis.
CONCLUSIONS: Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.