title: 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials.
abstract: OBJECTIVE
  The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS).
  
  
  BACKGROUND
  Clinical outcomes of diabetic patients after BVS implantation have been unreported.
  
  
  METHODS
  This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up.
  
  
  RESULTS
  The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group).
  
  
  CONCLUSIONS
  In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047).
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Muramatsu
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Robert-Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.affiliation: Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.affiliation: Krishna Heart Institute, Ahmedabad, India.
authors.forename: Tejas M
authors.initials: TM
authors.lastname: Patel
authors.affiliation: Fortis Escorts Heart Institute, New Delhi, India.
authors.forename: Ashok
authors.initials: A
authors.lastname: Seth
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Roberto
authors.initials: R
authors.lastname: Diletti
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: García-García
authors.affiliation: Abbott Vascular, Diegem, Belgium.
authors.forename: Cécile C
authors.initials: CC
authors.lastname: Dorange
authors.affiliation: Abbott Vascular, Diegem, Belgium.
authors.forename: Susan
authors.initials: S
authors.lastname: Veldhof
authors.affiliation: Abbott Vascular, Santa Clara, California.
authors.forename: Wai-Fung
authors.initials: WF
authors.lastname: Cheong
authors.affiliation: Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan.
authors.forename: Yukio
authors.initials: Y
authors.lastname: Ozaki
authors.affiliation: Cardiovascular Research Center, St. Vincent's Hospital, Melbourne, Victoria, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Whitbourn
authors.affiliation: Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Bartorelli
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York.
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: p.w.j.c.serruys@erasmusmc.nl.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic; D023921:Coronary Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D057216:Propensity Score; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus
keywords: bioresorbable scaffold; coronary artery disease; diabetes mellitus; drug-eluting stent