title: First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial.
abstract: BACKGROUND
  Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI.
  
  
  RESULTS
  The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P = 0.057).
  
  
  CONCLUSIONS
  In the treatment of bifurcation lesions, use of BES led to superior long-term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. © 2015 Wiley Periodicals, Inc.
authors.affiliation: Heartcenter, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Maik J
authors.initials: MJ
authors.lastname: Grundeken
authors.affiliation: Heartcenter, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Wykrzykowska
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ishibashi
authors.affiliation: East Lancashire Hospitals NHS Trust, Blackburn, United Kingdom.
authors.forename: Scot
authors.initials: S
authors.lastname: Garg
authors.affiliation: Cardialysis BV, Rotterdam, The Netherlands.
authors.forename: Ton
authors.initials: T
authors.lastname: de Vries
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.|Cardialysis BV, Rotterdam, The Netherlands.
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.|Cardialysis BV, Rotterdam, The Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Heartcenter, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Robbert J
authors.initials: RJ
authors.lastname: de Winter
authors.affiliation: American Heart of Poland, Ustroń, Poland.
authors.forename: Pawel
authors.initials: P
authors.lastname: Buszman
authors.affiliation: Herzzentrum Leipzig, Leipzig, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.affiliation: Kardiologie Im Zentrum, Munich, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Ischinger
authors.affiliation: Kardiologie Innenstadt, Munich, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.affiliation: Department of Cardiology, Triemli Spital, Zurich, Switzerland.
authors.forename: Franz
authors.initials: F
authors.lastname: Eberli
authors.affiliation: University Hospital Zurich, Zurich, Switzerland.
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.affiliation: Department of Cardiology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Institut Hospitalier Jacques-Cartier, Institut Cardiovasculaire Paris-Sud, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: Royal Brompton Hospital, London, United Kingdom.
authors.forename: Carlo
authors.initials: C
authors.lastname: di Mario
authors.affiliation: Department of Cardiology, University of Bern, Bern, Switzerland.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.affiliation: Department of Cardiology/University of Bern, CTU Bern and Institute of Social and Preventive Medicine, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: Biosensors Europe SA, Morges, Switzerland.
authors.forename: Ashkan
authors.initials: A
authors.lastname: Yazdani
authors.affiliation: Biosensors Europe SA, Morges, Switzerland.
authors.forename: Samuel
authors.initials: S
authors.lastname: Copt
authors.affiliation: Department of Cardiology, University of Bern, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: International Centre for Circulatory Health, NHLI, Imperial College London, London, the United Kingdom.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; C518022:umirolimus; D020123:Sirolimus
keywords: clinical trials (CLIN); coronary artery disease (CAD); percutaneous coronary intervention (PCI); percutaneous coronary intervention complex (PCIC)