title: Five-year clinical outcomes of sirolimus-eluting versus paclitaxel-eluting stents in high-risk patients.
abstract: OBJECTIVE
  First generation drug-eluting stents have shown differential efficacy in high-risk patient subsets at one year. It is unclear whether these differences endure over the medium- to long-term. We compared the five-year clinical efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a population of high-risk patients.
  
  
  METHODS
  The patient cohorts of the ISAR-DESIRE, ISAR-DIABETES, and ISAR-SMART-3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five-year follow-up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years.
  
  
  RESULTS
  A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44-0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80-1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02-1.34; P = 0.12).
  
  
  CONCLUSIONS
  In high-risk patient subsets the lower rate of 12-month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich. birkmeier@dhm.mhn.de
authors.forename: K Anette
authors.initials: KA
authors.lastname: Birkmeier
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Heidrun
authors.initials: H
authors.lastname: Holle
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.forename: Klaus
authors.initials: K
authors.lastname: Tiroch
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kufner
authors.forename: Steffen
authors.initials: S
authors.lastname: Massberg
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel; D020123:Sirolimus