Abbott Vascular's Absorb BVS Studied in Patients With Diabetes Mellitus
January 13, 2017—Findings from the Absorb Diabetic Substudy of Abbott Vascular's Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) were published by Dean J. Kereiakes, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2017;10:42–49). The investigators concluded that the substudy, "suggests the efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus."
The investigators noted that other randomized controlled trials have demonstrated comparable clinical outcomes after percutaneous coronary intervention with either the Absorb BVS or the metallic Xience everolimus-eluting stent (Abbott Vascular), but that these trials lack the power required to provide reliable treatment effect estimates in this high-risk population.
As summarized in JACC: Cardiovascular Interventions, this prespecified, powered analysis was composed of patients with diabetes who received one or more Absorb BVS and were pooled from the ABSORB II, III, and JAPAN randomized trials and from the single-arm ABSORB EXTEND registry. The study composite primary endpoint was target lesion failure (TLF) at 1 year after Absorb BVS implantation compared with a performance goal of 12.7%.
Among 754 diabetic patients included in the analysis (27.3% insulin treated), the 1-year TLF rate was 8.3%. Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller preprocedure reference vessel diameter as significant independent predictors of 1-year TLF, reported the investigators in JACC: Cardiovascular Interventions.