Clinical Trial Demonstrates that a Bioresorbable Scaffold is Non-Inferior to a Drug-eluting Stent in Patients with Coronary Artery Disease
Results of the ABSORB III Trial Presented at TCT 2015 and Published in the New England Journal of Medicine
SAN FRANCISCO – October 12, 2015 – Results from a clinical trial showed that an everolimus-eluting bioresorbable vascular scaffold was non-inferior after one year compared to a current generation metallic drug-eluting stent (DES) in patients with coronary artery disease for the primary endpoint of target lesion failure.
Findings from the ABSORB III trial were presented today at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The study was also published in the New England Journal of Medicine.
As the largest and pivotal clinical trial designed for regulatory approval, data from the ABSORB III trial will be reviewed by the FDA as it considers whether or not to approve this device.
Fully bioresorbable vascular scaffolds (BVS) have been developed to provide mechanical support and drug delivery functions similar to DES for approximately one year, followed by complete absorption back into the body over several years, potentially improving long-term clinical outcomes. However, whether BVS are as safe and effective as DES within the first year has not yet been established.
A prospective, multicenter, single-blind, active-treatment controlled clinical trial, ABSORB III measured the safety and efficacy of BVS compared to DES at one year in patients with obstructive coronary artery disease. The trial randomized 2,008 patients with myocardial ischemia undergoing treatment of one or two de novo native coronary artery lesions from 193 clinical sites. Patients were randomized 2:1 to receive an everolimus-eluting BVS (n=1,322) or a cobalt-chromium everolimus-eluting stent (CoCr-EES; n=686). The primary endpoint was target lesion failure (cardiac death, target-vessel myocardial infarction or ischemia-driven target lesion revascularization) at one year.
Target lesion failure (TLF) at one year occurred in 7.8% of BVS patients and 6.1% of CoCr-EES patients (difference [95% CI] = 1.7% [-0.5% to 3.9%], Pnoninferiority=0.007; Psuperiority=0.16). Patients treated with BVS and CoCr-EES had non-significantly different rates of cardiac death (0.6% vs. 0.1%, P=0.29), target-vessel myocardial infarction (6.0% vs. 4.6%, P=0.18), and stent thrombosis (1.5% vs. 0.7%, P=0.13). In addition, there were no statistically significant differences between BVS and CoCr-EES in the one-year rates of ischemia-driven target lesion revascularization (3.0% vs. 2.5%, P=0.50), angina (18.3% vs. 18.4%, P=0.93) or ischemia-driven TVR (5.0% vs. 3.7%, P=0.21).
“Bioresorbable vascular scaffolds are the newest generation of stent technology aimed at improving long-term outcomes in patients,” said lead investigator Dean J. Kereiakes, MD. Dr. Kereiakes is the Medical Director of The Christ Hospital Heart and Vascular Center and the Lindner Research Center at The Christ Hospital in Cincinnati, Ohio.
“Results from the ABSORB III trial showed that treatment of non-complex obstructive coronary artery disease with BVS was non-inferior to the best in class CoCr-EES for target lesion failure at one year. Long-term follow-up data from this and other large-scale trials are required to determine whether these findings translate into improved longer-term clinical outcomes beyond one year.”
Gregg W. Stone MD, study chairman of the ABSORB III trial noted, “This device may be an attractive alternative for young patients, for those with acute coronary syndromes in whom metallic stents heal poorly, and for patients and physicians wishing to avoid a permanent implant. The real potential advantages, however, are expected to emerge over time as the device dissolves, restoring the normal functioning of the coronary artery.” Dr. Stone is Co-Director of the Cardiovascular Research Foundation’s Medical Research and Education Division. He is also Professor of Medicine at Columbia University College of Physicians and Surgeons and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.
The ABSORB III trial was funded by Abbott Vascular. Dr. Kereiakes reports consulting fees from HCRI, Boston Scientific, Abbott Vascular, Svelte Medical Systems, Inc., Janssen Research & Development LLC, Sanofi-Aventis U.S. LLC, and major stock shareholder/equity in Ablative Solutions, Inc. Dr. Stone reports receiving personal fees from Osprey, Boston Scientific, InspireMD, TherOx, Atrium, Miracor, Eli Lilly-Daiichi Sankyo partnership, AstraZeneca, and Velomedix.