Two-Year Data from the First Randomized Comparison Between Bioresorbable Vascular Scaffolds and Everolimus-Eluting Metallic Stents Show Comparable Patient Outcomes
Results from the ABSORB II Study Reported at TCT 2015
SAN FRANCISCO – October 12, 2015 – Two-year follow-up data from the first randomized study comparing everolimus-eluting bioresobable stents (BVS) and metallic everolimus-eluting stents (EES) showed similar patient-oriented clinical outcomes for both devices.
Findings from ABSORB II were reported 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.
ABSORB II is the first randomized, single blind, active-controlled trial that compares a BVS to an EES. A total of 501 patients were randomized in a 2:1 ratio to BVS (n=335) or to EES (n=166).
While the primary endpoint of the trial is a three-year measure of vasomotion, the trial’s organizers reported second year clinical outcomes at TCT. One year outcomes were reported last year at TCT 2014.
The patient oriented composite endpoint (PoCE), comprised of all death, all myocardial infarction, and all revascularization, after two years was 11.6% for BVS compared to 12.8% for the EES (p=0.70). The device oriented composite endpoint (DoCE) or target lesion failure (TLF: a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization) was 7.0% for BVS compared to 3.0% for EES (p=0.07). Major adverse cardiac events (MACE) were 7.6% for BVS and 4.3% for EES (p=0.16). In addition, target vessel failure (comprised of cardiac death, all myocardial infarction, and clinically indicated target-vessel revascularization) was 8.5% for BVS and 6.7% for EES (p=0.48).
“After two years of follow-up, the bioresorbable vascular scaffold continued to demonstrate similar clinical outcomes as compared to an everolimus-eluting metal stent for the treatment of coronary artery disease,” said lead researcher Bernard R. Chevalier, MD from the Institut Cardiovasculaire Paris Sud.
“Larger randomized trials are needed to confirm these findings.”
The study was funded by Abbott Vascular. Dr. Chevalier reported that he is a consultant for Abbott Vascular.