JACC. Cardiovascular interventions · 2016
Efficacy and Safety of the Absorb Everolimus-Eluting Bioresorbable Scaffold for Treatment of Patients With Diabetes Mellitus: Results of the Absorb Diabetic Substudy.
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Kereiakes Dean J, Ellis Stephen G, Kimura Takeshi, Abizaid Alexandre, Zhao Weiying, Veldhof Susan, Vu Minh-Thien, Zhang Zhen, Onuma Yoshinobu, Chevalier Bernard, Serruys Patrick W, Stone Gregg W
Аннотация
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.
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.
Предметные рубрики MeSH
Absorbable ImplantsAge FactorsAgedCardiovascular AgentsChi-Square DistributionCoated Materials, BiocompatibleCoronary Artery DiseaseCoronary ThrombosisDiabetes MellitusEverolimusFemaleHumansHypoglycemic AgentsInsulinMaleMiddle AgedMultivariate AnalysisPercutaneous Coronary InterventionProportional Hazards ModelsProsthesis DesignRandomized Controlled Trials as TopicRegistriesRisk AssessmentRisk FactorsTime FactorsTreatment Outcome