title: Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System).
abstract: OBJECTIVE
  We compared the safety and efficacy of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) among the large cohort of randomized diabetic patients enrolled in the SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) trial.
  
  
  BACKGROUND
  Diabetes mellitus remains a significant predictor of adverse clinical outcomes after percutaneous coronary intervention with drug-eluting stents, and the comparative outcomes of different drug-eluting stents in diabetic patients remains ill-defined.
  
  
  METHODS
  In the SPIRIT IV trial, 3,687 patients with up to 3 de novo native coronary artery lesions were prospectively randomized 2:1 to receive EES or PES. Randomization was stratified by the presence of diabetes and lesion complexity. The primary end point was the occurrence of target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Clinical outcomes were evaluated in randomized diabetic (n = 1,185 [786 EES; 399 PES]) and nondiabetic patients (n = 2,498 [1,669 EES; 829 PES]).
  
  
  RESULTS
  The EES compared with PES reduced TLF in nondiabetic patients (3.1% vs. 6.7%, p < 0.0001), with significant reductions in myocardial infarction, stent thrombosis, and target lesion revascularization. In contrast, no difference in TLF (6.4% vs. 6.9%, respectively, p = 0.80) or any of its components was present among diabetic patients, regardless of insulin use. A significant interaction between the presence of diabetes and stent type on TLF (p(interaction) = 0.02) was observed.
  
  
  CONCLUSIONS
  In the SPIRIT IV randomized trial, EES compared with PES provided similar clinical outcomes in diabetic patients and superior clinical outcomes in nondiabetic patients at 1 year. (SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047).
authors.affiliation: The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education, Cincinnati, Ohio 45219, USA. Lindner@thechristhospital.com
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Applegate
authors.forename: John
authors.initials: J
authors.lastname: Wang
authors.forename: Manejeh
authors.initials: M
authors.lastname: Yaqub
authors.forename: Poornima
authors.initials: P
authors.lastname: Sood
authors.forename: Xiaolu
authors.initials: X
authors.lastname: Su
authors.forename: Guoping
authors.initials: G
authors.lastname: Su
authors.forename: Naim
authors.initials: N
authors.lastname: Farhat
authors.forename: Ali
authors.initials: A
authors.lastname: Rizvi
authors.forename: Charles A
authors.initials: CA
authors.lastname: Simonton
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D003324:Coronary Artery Disease / Q000150:complications / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017211:Treatment Failure
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus