title: 2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice.
abstract: OBJECTIVE
  This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with sirolimus-eluting stents (SES) with durable polymer through 2 years of follow-up.
  
  
  BACKGROUND
  BES with a biodegradable polymer provide similar efficacy and safety as SES with a durable polymer at 9 months. Clinical outcomes beyond the period of biodegradation of the polymer used for drug release and after discontinuation of dual antiplatelet therapy are of particular interest.
  
  
  METHODS
  A total of 1,707 patients were randomized to unrestricted use of BES (n = 857) or SES (n = 850) in an all-comers patient population.
  
  
  RESULTS
  At 2 years, BES remained noninferior compared with SES for the primary endpoint, which was a composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization (BES 12.8% vs. SES 15.2%, hazard ratio [HR]: 0.84, 95% confidence interval [CI]: 0.65 to 1.08, p(noninferiority) < 0.0001, p(superiority) = 0.18). Rates of cardiac death (3.2% vs. 3.9%, HR: 0.81, 95% CI: 0.49 to 1.35, p = 0.42), myocardial infarction (6.3% vs. 5.6%, HR: 1.12, 95% CI: 0.76 to 1.65, p = 0.56), and clinically indicated target vessel revascularization (7.5% vs. 8.6%, HR: 0.86, 95% CI: 0.62 to 1.20, p = 0.38) were similar for BES and SES. The rate of definite stent thrombosis through 2 years was 2.2% for BES and 2.5% for SES (p = 0.73). For the period between 1 and 2 years, event rates for definite stent thrombosis were 0.2% for BES and 0.5% for SES (p = 0.42). After discontinuation of dual antiplatelet therapy, no very late definite stent thrombosis occurred in the BES group.
  
  
  CONCLUSIONS
  At 2 years of follow-up, the unrestricted use of BES with a biodegradable polymer maintained a similar safety and efficacy profile as SES with a durable polymer. (Limus Eluted From a Durable Versus Erodable Stent Coating [LEADERS]; NCT00389220).
authors.affiliation: Department of Cardiology, University Hospital Munich (Innenstadt), Munich, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.forename: Pawel
authors.initials: P
authors.lastname: Buszman
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.forename: Thomas
authors.initials: T
authors.lastname: Ischinger
authors.forename: Franz
authors.initials: F
authors.lastname: Eberli
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.forename: Carlo
authors.initials: C
authors.lastname: di Mario
authors.forename: Robert Jan
authors.initials: RJ
authors.lastname: van Geuns
authors.forename: Gerrit-Anne
authors.initials: GA
authors.lastname: van Es
authors.forename: Bindu
authors.initials: B
authors.lastname: Kalesan
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D020341:Absorbable Implants; 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; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015996:Survival Rate; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; C518022:umirolimus; D020123:Sirolimus