title: Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial.
abstract: OBJECTIVE
  We sought to determine whether the differences in outcomes present between everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial at 1 year were sustained with longer-term follow-up.
  
  
  BACKGROUND
  In the SPIRIT IV trial, patients undergoing percutaneous coronary intervention who were randomized to EES compared with PES experienced lower 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target lesion revascularization [TLR]), with significant reductions in the individual rates of MI, TLR, and stent thrombosis.
  
  
  METHODS
  We prospectively randomized 3,687 patients with up to 3 noncomplex previously untreated native coronary artery lesions to EES versus PES at 66 U.S. sites. Follow-up through 2 years is complete in 3,578 patents (97.0%).
  
  
  RESULTS
  Treatment with EES compared with PES reduced the 2-year rates of TLF (6.9% vs. 9.9%, p = 0.003), all MI (2.5% vs. 3.9%, p = 0.02), Q-wave MI (0.1% vs. 0.8%, p = 0.002), stent thrombosis (0.4% vs. 1.2%, p = 0.008), and ischemia-driven TLR (4.5% vs. 6.9%, p = 0.004), with nonsignificantly different rates of all-cause and cardiac mortality. Between 1 year and 2 years, there were no significant differences in adverse event rates between the 2 stent types.
  
  
  CONCLUSIONS
  In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, the benefits of EES compared with those of PES present at 1 year were sustained at 2 years.
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, 111 East 59th Street, New York, NY 10022, USA. gs2184@columbia.edu
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Ali
authors.initials: A
authors.lastname: Rizvi
authors.forename: Krishnankutty
authors.initials: K
authors.lastname: Sudhir
authors.forename: William
authors.initials: W
authors.lastname: Newman
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Applegate
authors.forename: Louis A
authors.initials: LA
authors.lastname: Cannon
authors.forename: James T
authors.initials: JT
authors.lastname: Maddux
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.forename: Charles A
authors.initials: CA
authors.lastname: Simonton
authors.forename: Poornima
authors.initials: P
authors.lastname: Sood
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D023903:Coronary Restenosis; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013927:Thrombosis / Q000517:prevention & control; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000627:therapeutic use
chemical_list: D007166:Immunosuppressive Agents; D050257:Tubulin Modulators; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus