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Coronary artery disease
Original article
Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction
  1. Yao-Jun Zhang1,2,
  2. Javaid Iqbal1,
  3. Stephan Windecker3,
  4. Axel Linke4,
  5. Diethmar Antoni5,
  6. Hae Young Sohn6,
  7. Roberto Corti7,
  8. Gerrit-Anne van Es8,
  9. Samuel Copt9,
  10. Pedro Eerdmans9,
  11. Rana Saitta9,
  12. Marie-Claude Morice10,
  13. Carlo Di Mario11,
  14. Peter Juni12,
  15. William Wijns13,
  16. Pawel Buszman14,
  17. Patrick W Serruys1
  1. 1Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands
  2. 2Nanjing Medical University, Nanjing First Hospital, Nanjing, China
  3. 3Department of Cardiology, University of Bern, Bern, Switzerland
  4. 4Herzzentrum Leipzig, Leipzig, Germany
  5. 5Department of Cardiology, Hospital Bogenhausen, Munich, Germany
  6. 6Department of Cardiology, University Hospital Munich, Munich, Germany
  7. 7HerzKlinik Hirslanden, Zürich, Switzerland
  8. 8Cardialysis BV, Rotterdam, The Netherlands
  9. 9Biosensors Europe SA, Morges, Switzerland
  10. 10Institut Cardiovasculaire Paris-Sud, Institut Hospitalier Jacques-Cartier, Massy, France
  11. 11NIHR Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK
  12. 12CTU, University of Bern, Bern, Switzerland
  13. 13Department of Cardiology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
  14. 14American Heart of Poland, Ustroń, Poland
  1. Correspondence to Professor Patrick W Serruys, Thoraxcenter, Erasmus Medical Center, PO Box 2125, Rotterdam 3000 CC, the Netherlands; patrick.w.j.c.serruys{at}gmail.com

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.

Trial registration number NCT 00389220.

  • CORONARY ARTERY DISEASE
  • INTERVENTIONAL CARDIOLOGY
  • MYOCARDIAL ISCHAEMIA AND INFARCTION (IHD)

https://doi.org/10.1136/heartjnl-2014-306359

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