title: Efficacy and Safety of the Absorb Everolimus-Eluting Bioresorbable Scaffold for Treatment of Patients With Diabetes Mellitus: Results of the Absorb Diabetic Substudy.
abstract: 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.
  
  
  
  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.
  
  
  
  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%.
  
  
  
  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.
  
  
  
  The Absorb diabetic substudy suggests efficacy and safety of the Absorb BVS for treatment of patients with diabetes mellitus.
authors.affiliation: The Christ Hospital Heart and Vascular Center, The Lindner Research Center, Cincinnati, Ohio. Electronic address: lindner@thechristhospital.com.
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
authors.affiliation: Institute Dante Pazzanese of Cardiology, São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Weiying
authors.initials: W
authors.lastname: Zhao
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Minh-Thien
authors.initials: MT
authors.lastname: Vu
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Thorax Centre, Erasmus MC, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Institut Jacques Cartier, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.affiliation: International Centre for Cardiovascular Health, Imperial College, London, United Kingdom.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: New York Presbyterian Hospital, Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D020341:Absorbable Implants; D000367:Age Factors; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D003920:Diabetes Mellitus / Q000175:diagnosis / Q000188:drug therapy; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D007004:Hypoglycemic Agents; D007328:Insulin; D000068338:Everolimus
keywords: bioresorbable vascular scaffolds; coronary artery disease; diabetes