title: The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberté paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions.
abstract: BACKGROUND
  Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES).
  
  
  METHODS
  The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non-insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year.
  
  
  RESULTS
  Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; P(superiority) = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES (P = .11).
  
  
  CONCLUSIONS
  In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.
authors.affiliation: Department of Cardiology,University Hospital Bonn, Bonn, Germany. GrubeE@aol.com
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Giulio
authors.initials: G
authors.lastname: Guagliumi
authors.forename: Peter C
authors.initials: PC
authors.lastname: Smits
authors.forename: Marrianne
authors.initials: M
authors.lastname: Stuteville
authors.forename: Cécile
authors.initials: C
authors.lastname: Dorange
authors.forename: Peggy
authors.initials: P
authors.lastname: Papeleu
authors.forename: Upendra
authors.initials: U
authors.lastname: Kaul
authors.forename: Vladimír
authors.initials: V
authors.lastname: Džavík
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods* / Q000401:mortality; D001208:Asia; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D054855:Drug-Eluting Stents; D005060:Europe; D005069:Evaluation Studies as Topic; D000068338:Everolimus; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D018570:Risk Assessment; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D020946:Taxus; D016896:Treatment Outcome
chemical_list: D000068338:Everolimus; D020123:Sirolimus