Three-Year ABSORB III Trial Data Presented and Published for Abbott Vascular's BVS

October 31, 2017—The ABSORB III study assessed clinical outcomes through 3 years after implantation of the Absorb everolimus-eluting poly-L-lactic acid–based bioresorbable vascular scaffold (BVS; Abbott Vascular). The findings were published online by Dean J. Kereiakes, MD, et al in Journal of the American College of Cardiology and simultaneously presented as a late-breaking trial at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium being held October 30 to November 2 in Denver, Colorado.

Clinical outcomes from the trial were analyzed by randomized treatment assignment cumulative through 3 years and between 1 and 3 years. Previously, the ABSORB III data demonstrated noninferior rates of target lesion failure (TLF; defined as cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EESs).

As summarized in Journal of the American College of Cardiology, the primary composite endpoint of TLF through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (P = .06). Between 1 and 3 years, TLF occurred in 7% of BVS versus 6% of EES patients (P = .39).

Both TVMI and device thrombosis through 3 years were increased with BVS (8.6% vs 5.9%; P = .03 and 2.3% vs 0.7%; P = .01, respectively). In BVS-assigned patients, treatment of very small vessels (quantitatively determined reference vessel diameter < 2.25 mm) was an independent predictor of 3-year TLF and scaffold thrombosis.

The ABSORB III investigators concluded that the 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. They advised that longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis.