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Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland
  1. Roland Klingenberg1,
  2. Dik Heg2,
  3. Lorenz Räber3,
  4. David Carballo4,
  5. David Nanchen5,
  6. Baris Gencer4,
  7. Reto Auer5,
  8. Milosz Jaguszewski1,
  9. Barbara E Stähli1,
  10. Philipp Jakob1,
  11. Christian Templin1,
  12. Giulio G Stefanini3,
  13. Bernhard Meier3,
  14. Pierre Vogt6,
  15. Marco Roffi4,
  16. Willibald Maier1,
  17. Ulf Landmesser1,
  18. Nicolas Rodondi7,8,
  19. François Mach4,
  20. Stephan Windecker3,
  21. Peter Jüni2,
  22. Thomas F Lüscher1,
  23. Christian M Matter1
  1. 1Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland
  2. 2Clinical Trials Unit, Department of Clinical Research, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
  3. 3Department of Cardiology, Cardiovascular Center, University Hospital Bern, Bern, Switzerland
  4. 4Department of Cardiology, Cardiovascular Center, University Hospital Geneva, Geneva, Switzerland
  5. 5Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland
  6. 6Department of Cardiology, Cardiovascular Center, University Hospital Lausanne, Lausanne, Switzerland
  7. 7Department of General Internal Medicine, University Hospital Bern, Bern, Switzerland
  8. 8Institute of Social and Preventive Medicine, University Hospital Lausanne, Lausanne, Switzerland
  1. Correspondence to Professor Christian M Matter, Department of Cardiology, University Heart Center, Rämistrasse 100, Zurich 8091, Switzerland; christian.matter{at}usz.ch

Abstract

Objective To assess safety up to 1 year of follow-up associated with prasugrel and clopidogrel use in a prospective cohort of patients with acute coronary syndromes (ACS).

Methods Between 2009 and 2012, 2286 patients invasively managed for ACS were enrolled in the multicentre Swiss ACS Bleeding Cohort, among whom 2148 patients received either prasugrel or clopidogrel according to current guidelines. Patients with ST-elevation myocardial infarction (STEMI) preferentially received prasugrel, while those with non-STEMI, a history of stroke or transient ischaemic attack, age ≥75 years, or weight <60 kg received clopidogrel or reduced dose of prasugrel to comply with the prasugrel label.

Results After adjustment using propensity scores, the primary end point of clinically relevant bleeding events (defined as the composite of Bleeding Academic Research Consortium, BARC, type 3, 4 or 5 bleeding) at 1 year, occurred at a similar rate in both patient groups (prasugrel/clopidogrel: 3.8%/5.5%). Stratified analyses in subgroups including patients with STEMI yielded a similar safety profile. After adjusting for baseline variables, no relevant differences in major adverse cardiovascular and cerebrovascular events were observed at 1 year (prasugrel/clopidogrel: cardiac death 2.6%/4.2%, myocardial infarction 2.7%/3.8%, revascularisation 5.9%/6.7%, stroke 1.0%/1.6%). Of note, this study was not designed to compare efficacy between prasugrel and clopidogrel.

Conclusions In this large prospective ACS cohort, patients treated with prasugrel according to current guidelines (ie, in patients without cerebrovascular disease, old age or underweight) had a similar safety profile compared with patients treated with clopidogrel.

Clinical trial registration number SPUM-ACS: NCT01000701; COMFORTABLE AMI: NCT00962416.

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