title: Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland.
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.
  
  
  BACKGROUND
  SPUM-ACS: NCT01000701; COMFORTABLE AMI: NCT00962416.
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Roland
authors: R
authors: Klingenberg
authors: Clinical Trials Unit, Department of Clinical Research, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors: Dik
authors: D
authors: Heg
authors: Department of Cardiology, Cardiovascular Center, University Hospital Bern, Bern, Switzerland.
authors: Lorenz
authors: L
authors: Räber
authors: Department of Cardiology, Cardiovascular Center, University Hospital Geneva, Geneva, Switzerland.
authors: David
authors: D
authors: Carballo
authors: Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland.
authors: David
authors: D
authors: Nanchen
authors: Department of Cardiology, Cardiovascular Center, University Hospital Geneva, Geneva, Switzerland.
authors: Baris
authors: B
authors: Gencer
authors: Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland.
authors: Reto
authors: R
authors: Auer
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Milosz
authors: M
authors: Jaguszewski
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Barbara E
authors: BE
authors: Stähli
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Philipp
authors: P
authors: Jakob
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Christian
authors: C
authors: Templin
authors: Department of Cardiology, Cardiovascular Center, University Hospital Bern, Bern, Switzerland.
authors: Giulio G
authors: GG
authors: Stefanini
authors: Department of Cardiology, Cardiovascular Center, University Hospital Bern, Bern, Switzerland.
authors: Bernhard
authors: B
authors: Meier
authors: Department of Cardiology, Cardiovascular Center, University Hospital Lausanne, Lausanne, Switzerland.
authors: Pierre
authors: P
authors: Vogt
authors: Department of Cardiology, Cardiovascular Center, University Hospital Geneva, Geneva, Switzerland.
authors: Marco
authors: M
authors: Roffi
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Willibald
authors: W
authors: Maier
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Ulf
authors: U
authors: Landmesser
authors: Department of General Internal Medicine, University Hospital Bern, Bern, Switzerland Institute of Social and Preventive Medicine, University Hospital Lausanne, Lausanne, Switzerland.
authors: Nicolas
authors: N
authors: Rodondi
authors: Department of Cardiology, Cardiovascular Center, University Hospital Geneva, Geneva, Switzerland.
authors: François
authors: F
authors: Mach
authors: Department of Cardiology, Cardiovascular Center, University Hospital Bern, Bern, Switzerland.
authors: Stephan
authors: S
authors: Windecker
authors: Clinical Trials Unit, Department of Clinical Research, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors: Peter
authors: P
authors: Jüni
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Thomas F
authors: TF
authors: Lüscher
authors: Department of Cardiology, University Heart Center, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
authors: Christian M
authors: http://orcid.org/0000-0002-8124-1767
authors: CM
authors: Matter
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002561:Cerebrovascular Disorders / Q000139:chemically induced; D000077144:Clopidogrel; D054855:Drug-Eluting Stents; D005260:Female; D019983:Guideline Adherence; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D010879:Piperazines / Q000009:adverse effects*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D017410:Practice Guidelines as Topic; D000068799:Prasugrel Hydrochloride; D011446:Prospective Studies; D058921:Purinergic P2Y Receptor Antagonists / Q000009:adverse effects*; D012008:Recurrence; D012307:Risk Factors; D013876:Thiophenes / Q000009:adverse effects*; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010879:Piperazines; D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D013876:Thiophenes; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine