The Christ Hospital, Heart and Vascular Center, Lindner Research Center, Cincinnati, Ohio.
Cleveland Clinic, Cleveland, Ohio.
J Am Coll Cardiol. 2017 Dec 12;70(23):2852-2862. doi: 10.1016/j.jacc.2017.10.010. Epub 2017 Oct 31.
The Absorb everolimus-eluting poly-L-lactic acid-based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES).
This study sought to assess clinical outcomes through 3 years following BVS implantation.
Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years.
The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter <2.25 mm) was an independent predictor of 3-year TLF and scaffold thrombosis.
In the ABSORB III trial, 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906).
Absorb 依维莫司洗脱聚左旋乳酸基生物可吸收血管支架（BVS）提供了早期药物输送和机械支撑功能，类似于金属药物洗脱支架（DES），随后在大约 3 年内完全生物吸收，恢复血管结构和功能。ABSORB III 试验在 2008 例患有冠状动脉疾病的患者中比较了 BVS 与钴铬依维莫司洗脱支架（EES），结果显示 1 年时靶病变失败（心源性死亡、靶血管心肌梗死[TVMI]或缺血驱动的靶病变血运重建）的非劣效率。
本研究旨在评估 BVS 植入后 3 年的临床结果。
通过 3 年的随机治疗分配累积分析 ABSORB III 试验的临床结果，并在 1 年至 3 年之间进行比较。
BVS 组患者 3 年时的主要复合终点事件发生率为 13.4%，EES 组患者为 10.4%（p=0.06），1 年至 3 年之间分别为 7.0%和 6.0%（p=0.39）。BVS 组 3 年 TVMI 发生率较高（8.6% vs. 5.9%；p=0.03），器械血栓形成（2.3% vs. 0.7%；p=0.01）也较高。在 BVS 组患者中，治疗非常小的血管（定量确定参考血管直径<2.25mm）是 3 年时 TLR 和支架血栓形成的独立预测因素。
在 ABSORB III 试验中，BVS 的 3 年不良事件发生率高于 EES，尤其是 TVMI 和器械血栓形成。需要更长时间的临床随访来确定聚合物支架的生物吸收是否会影响患者的预后。（ABSORB III 随机对照试验[RCT] [ABSORB-III]；NCT01751906）。
