title: Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction.
abstract: OBJECTIVE
  To investigate clinical outcomes of coronary intervention using a biolimus-eluting stent (BES) compared with a sirolimus-eluting stent (SES) in patients with acute myocardial infarction (AMI) in the Limus Eluted from A Durable versus ERodable Stent (LEADERS) coating trial at the final 5-year follow-up.
  
  
  METHODS
  The LEADERS trial is a multicentre all-comer study, where patients (n=1707) were randomised to percutaneous intervention with either BES containing biodegradable polymer or SES containing durable polymer. Out of 1707 patients enrolled in this trial, 573 patients had percutaneous coronary intervention for AMI (BES=280, SES=293) and were included in the current analysis. Patient-oriented composite endpoint (POCE, including all death, all myocardial infarction (MI) and all revascularisations), major adverse cardiac events (MACE, including cardiac death, MI and clinically indicated target vessel revascularisation) and stent thrombosis were assessed at 5-year follow-up.
  
  
  RESULTS
  The baseline clinical, angiographic and procedural characteristics were well matched between BES and SES groups. In all patients with AMI, coronary intervention with a BES, compared with SES, significantly reduced POCE (28.9% vs 42.3%; relative risk (RR) 0.61, 95% CI 0.47 to 0.82, p=0.001) at 5-year follow-up. There was also a reduction in MACE rate in the BES group (18.2% vs 25.9%; RR 0.67, 95% CI 0.47 to 0.95, p=0.025); however, there was no difference in cardiac death and stent thrombosis. In patients with ST-elevation MI (STEMI), coronary intervention with BES significantly reduced POCE (24.4% vs 39.3%; RR 0.55, 95% CI 0.36 to 0.85, p=0.006), MACE (12.6% vs 25.0%; RR 0.47, 95% CI 0.26 to 0.83, p=0.008) and cardiac death (3.0% vs 11.4%; RR 0.25, 95% CI 0.08 to 0.75, p=0.007), along with a trend towards reduction in definite stent thrombosis (3.7% vs 8.6%; RR 0.41, 95% CI 0.15 to 1.18, p=0.088), compared with SES.
  
  
  CONCLUSIONS
  BES, compared with SES, significantly improved safety and efficacy outcomes in patients with AMI, especially those with STEMI, at 5-year follow-up.
  
  
  BACKGROUND
  NCT 00389220.
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands Nanjing Medical University, Nanjing First Hospital, Nanjing, China.
authors.forename: Yao-Jun
authors.initials: YJ
authors.lastname: Zhang
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Javaid
authors.initials: J
authors.lastname: Iqbal
authors.affiliation: Department of Cardiology, University of Bern, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Herzzentrum Leipzig, Leipzig, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.affiliation: Department of Cardiology, Hospital Bogenhausen, Munich, Germany.
authors.forename: Diethmar
authors.initials: D
authors.lastname: Antoni
authors.affiliation: Department of Cardiology, University Hospital Munich, Munich, Germany.
authors.forename: Hae Young
authors.initials: HY
authors.lastname: Sohn
authors.affiliation: HerzKlinik Hirslanden, Zürich, Switzerland.
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.affiliation: Cardialysis BV, Rotterdam, The Netherlands.
authors.forename: Gerrit-Anne
authors.initials: GA
authors.lastname: van Es
authors.affiliation: Biosensors Europe SA, Morges, Switzerland.
authors.forename: Samuel
authors.initials: S
authors.lastname: Copt
authors.affiliation: Biosensors Europe SA, Morges, Switzerland.
authors.forename: Pedro
authors.initials: P
authors.lastname: Eerdmans
authors.affiliation: Biosensors Europe SA, Morges, Switzerland.
authors.forename: Rana
authors.initials: R
authors.lastname: Saitta
authors.affiliation: Institut Cardiovasculaire Paris-Sud, Institut Hospitalier Jacques-Cartier, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK.
authors.forename: Carlo
authors.initials: C
authors.lastname: Di Mario
authors.affiliation: CTU, University of Bern, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Juni
authors.affiliation: Department of Cardiology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: American Heart of Poland, Ustroń, Poland.
authors.forename: Pawel
authors.initials: P
authors.lastname: Buszman
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000209:etiology; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011108:Polymers / Q000737:chemistry*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus
keywords: CORONARY ARTERY DISEASE; INTERVENTIONAL CARDIOLOGY; MYOCARDIAL ISCHAEMIA AND INFARCTION (IHD)