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. 2016 Oct 31;3(2):e000460.
doi: 10.1136/openhrt-2016-000460. eCollection 2016.

Bleeding events and maintenance dose of prasugrel: BLESS pilot study

Nazario Carrabba  1 , Guido Parodi  1 , Rossella Marcucci  2 , Renato Valenti  1 , Anna Maria Gori  3 , Angela Migliorini  1 , Vincenzo Comito  1 , Benedetta Bellandi  1 , Rosanna Abbate  2 , Gian Franco Gensini  3 , David Antoniucci  1
Affiliations

Bleeding events and maintenance dose of prasugrel: BLESS pilot study

Nazario Carrabba et al. Open Heart. .

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 (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.

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.

Keywords: PERCUTANEOUS CORONARY INTERVENTION; PHARMACOLOGY.

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Conflict of interest statement

GP reported receiving consulting fee from: AstraZeneca, Eli Lilly, The Medicines Company and Bayer. RM reported receiving honoraria for lectures from Daiichi Sankyo/Eli Lilly and Merck Sharp & Dohme. RA reported receiving consulting fees from Eli Lilly; lecture fees from Instrumentation Laboratory and Sigma Tau; and research grant funding from Bayer, BoehringerIngelheim and Pfizer. GFG reported receiving consulting fees from Bayer, BoehringerIngelheim and Eli Lilly; lecture fees from AstraZeneca, GlaxoSmithKline, Instrumentation Laboratory, Menarini and Sigma Tau; and research grant funding from Novo Nordisk, Merck Sharp & Dohme, Pfizer, Pierrel, Sanofi-Aventis and Servier. DA reported receiving consulting fees from Daiichi Sankyo/Eli Lilly and The Medicines Company and serving on the advisory boards of Cordis and CID.

Figures

Figure 1
Figure 1
BLESS trial flow chart. ACS, acute coronary syndrome; BLESS, Bleeding Events and Maintenance Dose of Prasugrel; PCI, percutaneous coronary intervention.
Figure 2
Figure 2
Time course and magnitude of changes of RPR within group B prasugrel 10/5 mg/day (─○─) and group A prasugrel 10/10 mg/day (─□─) and between groups. RPR, residual platelet reactivity.
Figure 3
Figure 3
BARC type ≥2 bleeding-free survival according to the treatment with 5 mg/day prasugrel MD group B (─), or 10 mg/day prasugrel MD group A (─). Event rates were compared by log-rank test. BARC, Bleeding Academic Research Consortium; MD, maintenance dose.
See this image and copyright information in PMC

References

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