Comparable outcomes with BVS, EES in ABSORB II interim 'need to be confirmed'
SAN FRANCISCO — An everolimus-eluting bioresorbable scaffold demonstrated similar clinical outcomes compared with a metallic everolimus-eluting stent in the treatment of CAD, according to interim follow-up data from the ABSORB II trial presented at the annual TCT Scientific Symposium.
“At 2 years, we are noticing no significant difference in the clinical outcomes between the two arms,” Bernard R. Chevalier, MD, of the Institut Jacques Cartier in Massy, France, said during a presentation.
Chevalier, with Patrick W. Serruys, MD, emeritus professor of interventional cardiology at Imperial College, London, and Thoraxcenter, Erasmus University, Rotterdam, Netherlands, and colleagues randomly assigned 501 patients in a 2:1 ratio to a bioresorbable vascular scaffold (BVS; Absorb, Abbott Vascular; n = 335) or to an everolimus-eluting stent (EES; Xience, Abbott Vascular; n = 166).
The primary endpoint of the single blind, active-controlled trial is vasomotion at 3 years.
The investigators analyzed outcomes in four categories: patient-oriented composite endpoints (all death, all MI and revascularization; MACE (cardiac death, all MI and clinically indicated target lesion revascularization); device-oriented composite endpoints/target lesion failure (cardiac death, target vessel MI and clinically indicated TLR); and target vessel failure (cardiac death, all MI and clinically indicated TLR).
The rates of patient-oriented clinical outcomes were 11.6% with BVS vs. 12.8% with EES (P = .70), and device-oriented clinical outcomes were 7% vs. 3%, respectively (P = .07). MACE measured 7.6% in the BVS group vs. 4.3% in the EES cohort (P = .16), and target vessel failure was 8.5% and 6.7%, respectively (P = .48).
The investigators note the 2-year endpoints represent non-prespecified interim analysis.
“The exploratory observations presented in this report are hypothesis-generating and need to be confirmed in larger randomized trials such as ABSORB III.” – by Allegra Tiver
Chevalier BR, et al. ABSORB II: A prospective randomized trial of an everolimus-eluting bioresorbable scaffold vs. an everolimus-eluting metallic stent in patients with coronary artery disease – two-year outcomes. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.
Disclosure: Chevalier reports consulting for Abbott Vascular. Serruys reports serving on the international advisory board for Abbott Vascular.