ABSORB II 2-Year Data Published for Abbott Vascular's Absorb BVS

October 24, 2016—The 2-year clinical outcomes of the ABSORB II trial were published by Bernard Chevalier, MD, et al in EuroIntervention (2016;12:1102–1107).

ABSORB II is evaluating Abbott Vascular’s Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) compared with Abbott Vascular’s Xience metallic everolimus-eluting stent (EES). In October 2015, Dr. Chevalier presented the 2-year data at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium, in San Francisco, California.

The 2-year clinical results demonstrate sustained low rates of patient-oriented composite endpoint (PoCE), major adverse cardiac events (MACE), device-oriented composite endpoint (DoCE), and target vessel failure (TVF) with the Absorb BVS as compared to the Xience stent, concluded the investigators in EuroIntervention.

In ABSORB II, the investigators randomly assigned 501 patients in a 2:1 ratio to receive treatment with the Absorb BVS (n = 334) or the Xience metallic EES (n = 167). Clinical follow-up at 2 years was available in 320 patients in the Absorb BVS arm and 160 patients in the XIENCE arm. 

As reported in EuroIntervention, the 2-year PoCE was 11.6% for the Absorb arm and 12.8% for the Xience arm (P = .7). The DoCE/target lersion failure at 2 years was 7% and 3% (P = .07), respectively. The hierarchical ischemia-driven MACE rate was 7.6% versus 4.3% (P = .16). The TVF rate was 8.5% versus 6.7% (P = .48). 

Additionally, the definite/probable thrombosis rate was 1.5% in the Absorb arm versus 0% in the Xience arm (P = .17). At 2 years, 36% of Absorb patients and 34% of Xience patients remained on dual-antiplatelet therapy and 92% of patients in both arms remained on aspirin, advised the investigators in EuroIntervention.