Bleeding events and maintenance dose of prasugrel: BLESS pilot study.

ABSTRACT: OBJECTIVE:To evaluate changes in residual platelet reactivity (RPR) over time, and bleeding and ischaemic events rate using 5 vs 10?mg maintenance dose (MD) regimens of prasugrel 1?month after acute coronary syndrome (ACS). BACKGROUND:The optimal level of RPR with prasugrel may change over time after an ACS. METHODS:After 60?mg loading dose of prasugrel (T0) followed by 10?mg/day for 1?month, patients were randomised to receive prasugrel 10?mg/day (n=95, group A) or 5?mg/day MD (n=98, group B) up to 1?year. RPR was assessed at T0, 37 (T1) and 180?days (T2). The primary end point was Bleeding Academic Research Consortium (BARC) bleeding events ?2 between 1 and 12?months, and the secondary composite end point was cardiac death, myocardial infarction, stroke and definite/probable stent thrombosis. RESULTS:From T0 to T1, RPR significantly increased in both groups A and B and the increase was higher for group B (? ADP 10?µmol: 13.8%±14.7% vs 23.5%±19.2%, p=0.001). At T2 a lower rate of high RPR patients were found in group A (2.6% vs13.3%; p=0.014). The BARC type ?2 bleeding occurred in 12.6% of group A versus 4.1% of group B (OR 0.29, 95% CI 0.09 to 0.94) and secondary end point in 2.1% vs 1.0% (p=0.542), respectively, without stent thrombosis. CONCLUSIONS:RPR increases shifting from 60?mg loading dose to 10?mg/day prasugrel MD with a further increase of RPR reducing prasugrel MD to 5?mg 1?month after ACS. Clinical value of these pharmacodynamic findings should be proved in larger clinical trials. TRIAL REGISTRATION NUMBER:NCT01790854.

SUBMITTER: Carrabba N 

PROVIDER: S-EPMC5093371 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature