BASKET-PROVE II: Safety of Prasugrel Compared to Clopidogrel in SCAD Patients
In stable coronary artery disease (SCAD), prasugrel had a similar safety profile as in acute coronary syndromes (ACS), according to results of the BASKET-PROVE II trial released Aug. 31 as part of ESC Congress 2015 in London. However, more major bleeding was observed in elderly and/or low-weight patients despite a reduced dose of prasugrel, as compared to clopidogrel.
The study prescribed 10mg of prasugrel to SCAD patients for one year. Patients at high risk for bleeding (i.e., >75 years and/or <60kg) received 5mg. The primary endpoint was major bleeding, with a secondary endpoint of ischemic events at two years. Results were compared between SCAD and ACS and with SCAD patients on clopidogrel in a historical control.
Overall results found that major bleedings were not different between SCAD (n=845) and ACS (n=1,446) on prasugrel (2.2 vs. 3.3 percent, aHR 0.66 [0.37,1.19], p=0.167). But study investigators did note a greater occurrence of major bleedings in high risk patients during treatment. Compared with SCAD patients on clopidogrel (n=822), those on prasugrel had somewhat more major bleedings during treatment (1.8 vs. 1.0 percent, aHR 4.79 [0.98, 23.3], p=0.052), however this difference was no longer present if high-bleeding-risk patients on prasugrel were excluded. Ischemic events were not different between SCAD and ACS patients on prasugrel (3.4 vs. 4.6 percent, aHR 0.78 [0.49, 1.26], p=0.307).
According to study investigators, the increased bleeding rate in high-bleeding risk patients raises an important concern regarding the safety of current label prescriptions of 5mg prasugrel.
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