title: Everolimus-eluting stents in patients undergoing percutaneous coronary intervention: final 3-year results of the Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions trial.
abstract: OBJECTIVE
  We compared the outcomes of patients treated with everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) at 3 years from the large-scale randomized SPIRIT IV trial.
  
  
  BACKGROUND
  SPIRIT IV is the largest randomized trial comparing the outcomes of EES and PES. The present report represents the final long-term follow-up analysis from this study.
  
  
  METHODS
  A total of 3,687 patients were randomized 2:1 to EES or PES, stratified by presence of diabetes mellitus and lesion characteristics. Prespecified subgroups were compared for interaction with stent allocation. The primary end point was target lesion failure (TLF) (the composite of cardiac death, target vessel-related myocardial infarction [MI], or ischemia-driven target lesion revascularization).
  
  
  RESULTS
  At 3 years, TLF occurred in 9.2% versus 11.7% of EES- and PES-treated patients (hazard ratio [HR] 0.78 [0.63-0.97], P = .02). The incidence of death or MI was 5.9% versus 9.1%, respectively (HR 0.67 [0.52-0.85], P = .001), and there was a 64% reduction in stent thrombosis (Academic Research Consortium definite or probable definition) with EES (0.59% vs 1.60%, HR 0.36 [0.18-0.72], P = .003). The difference in target lesion revascularization at 3 years did not reach statistical significance (6.2% vs 7.8%, respectively, HR 0.78 [0.60-1.01], P = .06). There was no significant interaction between treatment allocation and any of the subgroups, including diabetes.
  
  
  CONCLUSIONS
  When compared with PES, EES provides durable and significant reduction in TLF, especially due to its enhanced safety profile, with lower rates of death or MI and stent thrombosis up to 3 years.
authors.affiliation: NY Methodist Hospital and the Cardiovascular Research Foundation, New York, NY. Electronic address: sjb9005@nyp.org.
authors.forename: Sorin J
authors.initials: SJ
authors.lastname: Brener
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Charles A
authors.initials: CA
authors.lastname: Simonton
authors.forename: Ali
authors.initials: A
authors.lastname: Rizvi
authors.forename: William
authors.initials: W
authors.lastname: Newman
authors.forename: Kourosh
authors.initials: K
authors.lastname: Mastali
authors.forename: John C
authors.initials: JC
authors.lastname: Wang
authors.forename: Ronald
authors.initials: R
authors.lastname: Caputo
authors.forename: Robert S
authors.initials: RS
authors.lastname: Smith
authors.forename: Shih-Wa
authors.initials: SW
authors.lastname: Ying
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation / Q000379:methods*; D016016:Proportional Hazards Models; D011475:Prosthesis Failure; D016037:Single-Blind Method; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000627:therapeutic use*
chemical_list: D007166:Immunosuppressive Agents; D050257:Tubulin Modulators; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus