Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland.

Klingenberg, Roland; Heg, Dik; Räber, Lorenz; Carballo, David; Nanchen, David; Gencer, Baris; Auer, Reto; Jaguszewski, Milosz; Stähli, Barbara E; Jakob, Philipp; Templin, Christian; Stefanini, Giulio G; Meier, Bernhard; Vogt, Pierre; Roffi, Marco; Maier, Willibald; Landmesser, Ulf; Rodondi, Nicolas; Mach, François; Windecker, Stephan; ... (2015). Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland. Heart (British Cardiac Society), 101(11), pp. 854-863. BMJ Publishing Group 10.1136/heartjnl-2014-306925

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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.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Heg, Dierik Hans; Räber, Lorenz; Stefanini, Giulio; Meier, Bernhard; Rodondi, Nicolas; Windecker, Stephan and Jüni, Peter


600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services




BMJ Publishing Group




Doris Kopp Heim

Date Deposited:

10 Apr 2015 16:29

Last Modified:

26 Sep 2017 22:29

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