title: Bleeding events and maintenance dose of prasugrel: BLESS pilot study.
abstract: 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).
  
  
  
  The optimal level of RPR with prasugrel may change over time after an ACS.
  
  
  
  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.
  
  
  
  From T0 to T1, RPR significantly increased in both groups A and B and the increase was higher for group B (δ 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.
  
  
  
  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.
  
  
  
  NCT01790854.
authors.affiliation: Department of Cardiology , Careggi Hospital , Florence , Italy.
authors.forename: Nazario
authors.identifier: 0000-0002-5190-5227
authors.initials: N
authors.lastname: Carrabba
authors.affiliation: Department of Cardiology , Careggi Hospital , Florence , Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Parodi
authors.affiliation: Department of Experimental and Clinical Medicine , University of Florence, Florence, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Marcucci
authors.affiliation: Department of Cardiology , Careggi Hospital , Florence , Italy.
authors.forename: Renato
authors.initials: R
authors.lastname: Valenti
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence,Florence, Italy; Don Gnocchi Foundation, Florence, Italy.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Gori
authors.affiliation: Department of Cardiology , Careggi Hospital , Florence , Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: Migliorini
authors.affiliation: Department of Cardiology , Careggi Hospital , Florence , Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Comito
authors.affiliation: Department of Cardiology , Careggi Hospital , Florence , Italy.
authors.forename: Benedetta
authors.initials: B
authors.lastname: Bellandi
authors.affiliation: Department of Experimental and Clinical Medicine , University of Florence, Florence, Italy.
authors.forename: Rosanna
authors.initials: R
authors.lastname: Abbate
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence,Florence, Italy; Don Gnocchi Foundation, Florence, Italy.
authors.forename: Gian Franco
authors.initials: GF
authors.lastname: Gensini
authors.affiliation: Department of Cardiology , Careggi Hospital , Florence , Italy.
authors.forename: David
authors.initials: D
authors.lastname: Antoniucci
keywords: PERCUTANEOUS CORONARY INTERVENTION; PHARMACOLOGY