Bleeding events and maintenance dose of prasugrel: BLESS pilot study.
Open Heart
; 3(2): e000460, 2016.
Article
en En
| MEDLINE
| ID: mdl-27843564
ABSTRACT
OBJECTIVE:
To evaluate changes in residual platelet reactivity (RPR) over time, and bleeding and ischaemic events rate using 5 vs 10â mg maintenance dose (MD) regimens of prasugrel 1â month after acute coronary syndrome (ACS).BACKGROUND:
The optimal level of RPR with prasugrel may change over time after an ACS.METHODS:
After 60â mg loading dose of prasugrel (T0) followed by 10â mg/day for 1â month, patients were randomised to receive prasugrel 10â mg/day (n=95, group A) or 5â mg/day MD (n=98, group B) up to 1â year. RPR was assessed at T0, 37 (T1) and 180â days (T2). The primary end point was Bleeding Academic Research Consortium (BARC) bleeding events ≥2 between 1 and 12â 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 (δ ADP 10â 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 60â mg loading dose to 10â mg/day prasugrel MD with a further increase of RPR reducing prasugrel MD to 5â mg 1â month after ACS. Clinical value of these pharmacodynamic findings should be proved in larger clinical trials. TRIAL REGISTRATION NUMBER NCT01790854.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Open Heart
Año:
2016
Tipo del documento:
Article
País de afiliación:
Italia