Dean J Kereiakes1, Stephen G Ellis2, Takeshi Kimura3, Alexandre Abizaid4, Weiying Zhao5, Susan Veldhof5, Minh-Thien Vu5, Zhen Zhang5, Yoshinobu Onuma6, Bernard Chevalier7, Patrick W Serruys8, Gregg W Stone9. 1. The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, Ohio. Electronic address: lindner@thechristhospital.com. 2. Cleveland Clinic, Cleveland, Ohio. 3. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. 4. Institute Dante Pazzanese of Cardiology, São Paulo, Brazil. 5. Abbott Vascular, Santa Clara, California. 6. Thorax Centre, Erasmus MC, Rotterdam, the Netherlands. 7. Institut Jacques Cartier, Massy, France. 8. International Centre for Cardiovascular Health, Imperial College, London, United Kingdom. 9. New York Presbyterian Hospital, Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
Abstract
OBJECTIVES: The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus. BACKGROUND: Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population. METHODS: In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb 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 following Absorb BVS compared with a performance goal of 12.7%. RESULTS: Among 754 diabetic patients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF. CONCLUSIONS: The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.
OBJECTIVES: The study sought to evaluate the efficacy and safety of the Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Abbott Park, Illinois) in patients with diabetes mellitus. BACKGROUND: Randomized, controlled trials have demonstrated comparable clinical outcomes following percutaneous coronary intervention with either Absorb BVS or metallic Xience everolimus-eluting stent. However, these trials lack power required to provide reliable treatment effect estimates in this high-risk population. METHODS: In a pre-specified, powered analysis, patients with diabetes who received ≥1 Absorb 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 following Absorb BVS compared with a performance goal of 12.7%. RESULTS: Among 754 diabeticpatients included in analysis (27.3% insulin treated), the 1-year TLF rate was 8.3% (upper 1-sided 95% confidence limit: 10.1%; p = 0.0001 vs. performance goal). Scaffold thrombosis (definite or probable) was observed in 2.3% of patients. Multivariable regression identified older age, insulin treatment, and smaller pre-procedure reference vessel diameter as significant independent predictors of 1-year TLF. CONCLUSIONS: The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.
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