ABSORB III: Bioresorbable scaffold noninferior to cobalt-chromium stent
SAN FRANCISCO — An everolimus-eluting bioresorbable vascular scaffold was noninferior to a cobalt-chromium everolimus-eluting stent for target lesion failure in patients with noncomplex obstructive CAD at 1 year in the ABSORB III trial.
“The primary endpoint for this trial has been met,” Dean J. Kereiakes, MD, FACC, medical director at The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, and a member of the Cardiology Today’s Intervention Editorial Board, said in a presentation. “The [TLF] components of cardiac death, target vessel MI and ischemia-driven target lesion revascularization were not significantly different between the devices.”
Dean J. Kereiakes
The large-scale multicenter trial randomly assigned 2,008 patients with stable or unstable angina in a 2:1 ratio to an everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular; n = 1,322) or a cobalt-chromium everolimus-eluting stent (Xience, Abbott Vascular; n = 686).
The investigators sought TLF including CV death, target vessel MI or ischemia-driven TLR as primary endpoints, testing for noninferiority at a margin of 4.5 percentage points for risk difference as well as superiority.
At 1 year, 7.8% of patients with bioresorbable scaffold experienced TLF vs. 6.1% of patients with cobalt-chromium stent (difference, 1.7 percentage points; 95% CI, –0.5 to 3.9).
No differences were observed between the bioresorbable scaffold and cobalt-chromium stent groups for CV death (0.6% vs. 0.1%; P = .29), target vessel MI (6% vs. 4.6%; P = .18) or ischemia-driven TLR (3% vs. 2.5%; P = .5).
The powered secondary endpoints of angina, all revascularization and ischemia-driven TVR were similar between the devices. Similar results were seen for device thrombosis, occurring in 1.5% of patients with bioresorbable scaffold and 0.7% of patients with cobalt-chromium stent (P = .13).
“The ABSORB III trial has demonstrated safety and efficacy of Absorb [bioresorbable vascular scaffold] at 1 year in patients with stable CAD and stabilized ACS,” Kereiakes said. “Longer-term evaluation is ongoing to determine if Absorb improves late outcomes compared to Xience.” – by Allegra Tiver
Ellis SG, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1509038.
Kereiakes DJ. Am Heart J. 2015;doi:10.1016/j.ahj.2015.07.013.
Kereiakes DJ. ABSORB III: A prospective randomized trial of an everolimus-eluting bioresorbable scaffold vs. an everolimus-eluting metallic stent in patients with coronary artery disease. Presented at: TCT 2015; Oct. 11-15, 2015; San Francisco.
Disclosure: Kereiakes reports multiple financial relationships in consulting, research and speakers capacities with Abbott Vascular, Boston Scientific Corp. and Svelte Medical Systems Inc., as well as using the off-label bioresorbable vascular scaffold to treat atherosclerosis.