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Clinical Outcomes Prior to and Following Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial.

Background: The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to metallic drug-eluting stents, followed by complete resorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated non-inferior rates of target lesion failure (TLF; cardiac death, target vessel myocardial infarction [TVMI] or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents (EES). Between 1 year and 3 years, and cumulative to 3 years adverse event rates (particularly TVMI and scaffold thrombosis [ST]) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. Methods: Clinical outcomes from ABSORB III were analyzed by randomized device (intentionto-treat) cumulative to 5 years and between 3-5 years. Results: Rates of TLF, TVMI and ST were increased through 5-year follow-up with BVS compared with EES. However, between 3 and 5 years, reductions in the relative hazards of BVS compared with EES were observed, particularly for TLF (HR [95% CI] 0.82 [0.55, 1.24] versus 1.35 [1.02, 1.78]; pint=0.052) and ST (HR [95% CI] 0.26 [0.02, 2.86] versus 3.23 [1.25, 8.30];pint=0.056) compared to the 0-3 year time period. Conclusions: In the ABSORB III trial, cumulative 5-year adverse event rates were increased following BVS compared with EES. However, the period of excess risk for BVS ended at 3 years coincident with complete scaffold resorption. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique identifier: NCT01751906.