Bivalirudin versus heparin monotherapy in myocardial infarction

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y12 inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors. METHODS: In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent P2Y12 inhibitor (ticagrelor, prasugrel, or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors. The patients were randomly assigned to receive bivalirudin or heparin during PCI, which was performed predominantly with the use of radial-artery access. The primary end point was a composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up. RESULTS: A total of 6006 patients (3005 with STEMI and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point event had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients with STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction occurred in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin group (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6% and 8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite stent thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27 to 1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95% CI, 0.78 to 1.41; P=0.76). CONCLUSIONS: Among patients undergoing PCI for myocardial infarction, the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin than among those who received heparin monotherapy.

Details

Authors
  • E. Omerovic
  • Ole Fröbert
  • R. Linder
  • Mikael Danielewicz
  • Mohamed Abdel-Hamid
  • E. Swahn
  • L. Henareh
  • Peter Hårdhammar
  • Iwar Sjögren
  • J. Stewart
  • Per Grimfjärd
  • J. Jensen
  • Mikael Aasa
  • L Robertsson
  • P. Lindroos
  • Jan Haupt
  • H. Wikström
  • A. Ulvenstam
  • P. Bhiladvala
  • B. Lindvall
  • A. Lundin
  • T. Tödt
  • D. Ioanes
  • Truls Råmunddal
  • Thomas Kellerth
  • L. Zagozdzon
  • M. Götberg
  • J. Andersson
  • Oskar Angerås
  • Olof Östlund
  • B. Lagerqvist
  • Claes Held
  • L. Wallentin
  • P. Eriksson
  • S. Koul
  • S James
Organisations
External organisations
  • Sahlgrenska University Hospital
  • Örebro University
  • Danderyd Hospital
  • Mälar Hospital
  • Linköping University Hospital
  • Karolinska University Hospital
  • Helsingborg Hospital
  • Halmstad County Hospital
  • Falun Central Hospital
  • Skaraborg Hospital
  • Västmanland Hospital
  • Karolinska Institutet
  • Södersjukhuset
  • South Elfsborg Hospital
  • Sunderby Hospital
  • Central Hospital Kristianstad
  • Östersund Hospital
  • Sundsvall Hospital
  • Umeå University
  • Uppsala University Hospital
  • Lund University
  • Capio St. Görans Sjukhus
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cardiac and Cardiovascular Systems
Original languageEnglish
Pages (from-to)1132-1142
JournalNew England Journal of Medicine
Volume377
Issue number12
Publication statusPublished - 2017 Sep 21
Publication categoryResearch
Peer-reviewedYes