3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial
Dean J Kereiakes, Stephen G Ellis, Christopher Metzger, Ronald P Caputo, David G Rizik, Paul S Teirstein, Marc R Litt, Annapoorna Kini, Ameer Kabour, Steven O Marx, Jeffrey J Popma, Robert McGreevy, Zhen Zhang, Charles Simonton, Gregg W Stone, ABSORB III Investigators, Dean J Kereiakes, Stephen G Ellis, Christopher Metzger, Ronald P Caputo, David G Rizik, Paul S Teirstein, Marc R Litt, Annapoorna Kini, Ameer Kabour, Steven O Marx, Jeffrey J Popma, Robert McGreevy, Zhen Zhang, Charles Simonton, Gregg W Stone, ABSORB III Investigators
Abstract
Background: 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).
Objectives: This study sought to assess clinical outcomes through 3 years following BVS implantation.
Methods: Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years.
Results: 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.
Conclusions: 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).
Keywords: bioresorbable scaffold; prognosis; randomized trial; stent.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed