title: Five-year clinical and angiographic outcomes of a randomized comparison of sirolimus-eluting and paclitaxel-eluting stents: results of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization LATE trial.
abstract: BACKGROUND
  Long-term comparative data of first-generation drug-eluting stents are scarce. We investigated clinical and angiographic outcomes of sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) at 5 years as part of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) LATE study.
  
  
  RESULTS
  A total of 1012 patients were randomly assigned to SES or PES. Repeat angiography was completed in 444 of 1012 patients (43.8%) at 5 years. Major adverse cardiac events occurred in 19.7% of SES- and 21.4% of PES-treated patients (hazard ratio, 0.89; 95% confidence interval, 0.68 to 1.17; P=0.39) at 5 years. There were no differences between SES and PES in terms of cardiac death (5.8% versus 5.7%; P=0.35), myocardial infarction (6.6% versus 6.9%; P=0.51), and target lesion revascularization (13.1% versus 15.1%; P=0.29). Between 1 and 5 years, the annual rate of target lesion revascularization was 2.0% (95% confidence interval, 1.4% to 2.6%) for SES and 1.4% (95% confidence interval, 0.9% to 2.0%) for PES. Among patients undergoing paired angiography at 8 months and 5 years, delayed lumen loss amounted to 0.37 ± 0.73 mm for SES and 0.29 ± 0.59 mm for PES (P=0.32). The overall rate of definite stent thrombosis was 4.6% for SES and 4.1% for PES (P=0.74), and very late definite stent thrombosis occurred at an annual rate of 0.65% (95% confidence interval, 0.40% to 0.90%).
  
  
  CONCLUSIONS
  Long-term follow-up of first-generation drug-eluting stents shows no significant differences in clinical and angiographic outcomes between SES and PES. The continuous increase in late lumen loss in conjunction with the ongoing risk of very late stent thrombosis suggests that vascular healing remains incomplete up to 5 years after implantation of first-generation drug-eluting stents.
authors.affiliation: Department of Cardiology, Bern University Hospital, 3010 Bern, Switzerland.
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.forename: Lea
authors.initials: L
authors.lastname: Wohlwend
authors.forename: Mathias
authors.initials: M
authors.lastname: Wigger
authors.forename: Mario
authors.initials: M
authors.lastname: Togni
authors.forename: Simon
authors.initials: S
authors.lastname: Wandel
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cook
authors.forename: Aris
authors.initials: A
authors.lastname: Moschovitis
authors.forename: Rolf
authors.initials: R
authors.lastname: Vogel
authors.forename: Bindu
authors.initials: B
authors.lastname: Kalesan
authors.forename: Christian
authors.initials: C
authors.lastname: Seiler
authors.forename: Franz
authors.initials: F
authors.lastname: Eberli
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Lüscher
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D003324:Coronary Artery Disease / Q000628:therapy*; D003328:Coronary Thrombosis / Q000517:prevention & control; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D020123:Sirolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus