Two-Year ABSORB II Data Presented for Abbott Vascular's BVS

October 12, 2015—Two-year follow-up data from ABSORB II, the first randomized study comparing everolimus-eluting bioresorbable vascular stents (BVS) and metallic everolimus-eluting stents (EES) showed similar patient-oriented clinical outcomes for both devices, according to a presentation at the TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium, being held October 11–15 in San Francisco, California.

ABSORB II is a single-blind, active-controlled trial that comparing Abbott Vascular’s Absorb BVS to the company’s Xience EES. A total of 501 patients were randomized in a 2:1 ratio to BVS (n = 335) or to EES (n = 166). The primary endpoint of the trial is a 3-year measure of vasomotion. One-year ABSORB II outcomes were reported at TCT 2014 in Washington, DC.

At TCT 2015, the ABSORB II investigators presented 2-year clinical outcomes. The investigators reported that the patient-oriented composite endpoint (the rate of all death, all myocardial infarction, and all revascularization) after 2 years was 11.6% for BVS compared to 12.8% for the EES (P = .7). The device-oriented composite endpoint of the rate of target lesion failure (cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization) was 7% for BVS compared to 3% for EES (P = .07). The major adverse cardiac event rate was 7.6% for BVS and 4.3% for EES (P = .16). In addition, target vessel failure, including cardiac death, all myocardial infarction, and clinically indicated target vessel revascularization) was 8.5% for BVS and 6.7% for EES (P = .48).

ABSORB II lead investigator Bernard R. Chevalier, MD, from the Institut Cardiovasculaire Paris Sud in Massy, France, commented in the TCT press release, “After 2 years of follow-up, the BVS continued to demonstrate similar clinical outcomes as compared to a metallic EES for the treatment of coronary artery disease.” However, he noted, “Larger randomized trials are needed to confirm these findings.”