One-Year ABSORB III Data Presented for Abbott Vascular's Absorb Bioresorbable Vascular Scaffold

October 12, 2015—Findings from the ABSORB III randomized clinical trial were presented at the TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation (CRF), being held October 11–15 in San Francisco, California. The study was simultaneously published by Stephen G. Ellis, MD, et al online ahead of print in The New England Journal of Medicine.

Results from ABSORB III showed that Abbott Vascular’s Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) was noninferior after 1-year compared to Abbott Vascular’s current-generation Xience cobalt chromium everolimus-eluting stent (CoCr EES) in patients with coronary artery disease for the primary endpoint of target lesion failure. 

Abbott Vascular funded the ABSORB III trial. Data from the trial will be reviewed by the US Food and Drug Administration in its consideration of the Absorb BVS for approval.

ABSORB III is a prospective, multicenter, single-blind, active-treatment controlled clinical trial that is measuring the safety and efficacy of the BVS compared to the CoCR EES at 1 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 the Absorb BVS (n = 1,322) or the Xience CoCr EES (n = 686). The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization [TVR]) at 1 year.

Target lesion failure at 1 year occurred in 7.8% of BVS patients and 6.1% of Xience CoCr EES patients (difference, 1.7%; 95% confidence interval [CI], -0.5% to 3.9%; P-noninferiority = .007; P-superiority = .16). Patients treated with the Absorb BVS and the Xience CoCr EES had nonsignificantly different rates of cardiac death (0.6% vs 0.1%; P = .29), target vessel myocardial infarction (6% vs 4.6%; P = .18), and stent thrombosis (1.5% vs 0.7%; P = .13). In addition, there were no statistically significant differences between the Absorb BVS and Xience CoCr EES in the 1-year rates of ischemia-driven target lesion revascularization (3% vs 2.5%; P = .5), angina (18.3% vs 18.4%; P = .93), or ischemia-driven TVR (5% vs 3.7%; P = .21).

In the TCT announcement, ABSORB III lead investigator, Dean J. Kereiakes, MD comment, “BVSs are the newest generation of stent technology aimed at improving long-term outcomes in patients. Results from the ABSORB III trial showed that treatment of noncomplex obstructive coronary artery disease with BVS was noninferior 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 1 year.” 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.

ABSORB III study chairman, Gregg W. Stone MD, added, “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, who serves as Codirector of CRF’s Medical Research and Education Division, is 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 in New York, New York.