Résumé
The aim of this study was to evaluate one-year incidence of bleeding events and their impact on compliance in patients admitted for ST Elevation Myocardial Infarction (STEMI) and treated by prasugrel or clopidogrel in « real-world ».
Patients admitted for a STEMI were treated by either clopidogrel or prasugrel according to the physician with respect of guidelines. The primary endpoint was the first occurrence of bleeding events within 12 months assessed by the Bleeding Academic Research Consortium (BARC) classification using a dedicated questionnaire focused on bleeding events. Topography bleedings, causes of premature cessation and ischemic events were also compared.
390 patients were enrolled, 211 in prasugrel group and 179 in clopidogrel group. Patients in the prasugrel group were younger, with higher body weight and were more frequently men. At 12 months, a bleeding complication occurred in 40% of patients regardless of its severity or treatment prescribed. Major bleedings (BARC 3) were significantly lower with prasugrel than clopidogrel (1% versus 6%, p=0.001). Minimal bleedings (BARC 1) were more frequent in clopidogrel group than prasugrel group (respectively 27% and 18%; p=0.05). However BARC 2 bleedings occurred more often in prasugrel group (14% versus 6%, p=0.01) (figure). Subcutaneous and gastrointestinal haemorraghes were the most frequent. Over one-year, the rate of cessation was 18% in the prasugrel group and only 10% in the clopidogrel group (p=0.04). Respectively for prasugrel and clopidogrel, rates of recommend discontinuation were 10% and 4% (p=0.02) and of disruption were 8% and 5% (p=0.3). Despite more frequent discontinuation, mortality remains very low in the prasugrel group (0.5% versus 7%, p=0.0003).
In real-world, in a low bleeding risk population, the rate of major bleedings with prasugrel at 12 months was low but nuisance bleedings were frequent with significant impact on premature cessation
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