Bleeding events and maintenance dose of prasugrel: BLESS pilot study

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article numbere000460
JournalOpen Heart
Volume3
Issue number2
DOIs
Publication statusPublished - Oct 1 2016

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Blood Platelets
Hemorrhage
Acute Coronary Syndrome
Stents
Thrombosis
Bleeding Time
Prasugrel Hydrochloride
Research
Adenosine Diphosphate
Stroke
Myocardial Infarction
Clinical Trials

Keywords

  • PERCUTANEOUS CORONARY INTERVENTION
  • PHARMACOLOGY

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Carrabba, N., Parodi, G., Marcucci, R., Valenti, R., Gori, A. M., Migliorini, A., ... Antoniucci, D. (2016). Bleeding events and maintenance dose of prasugrel: BLESS pilot study. Open Heart, 3(2), [e000460]. https://doi.org/10.1136/openhrt-2016-000460

Bleeding events and maintenance dose of prasugrel : BLESS pilot study. / Carrabba, Nazario; Parodi, Guido; Marcucci, Rossella; Valenti, Renato; Gori, Anna Maria; Migliorini, Angela; Comito, Vincenzo; Bellandi, Benedetta; Abbate, Rosanna; Gensini, Gian Franco; Antoniucci, David.

In: Open Heart, Vol. 3, No. 2, e000460, 01.10.2016.

Research output: Contribution to journalArticle

Carrabba, N, Parodi, G, Marcucci, R, Valenti, R, Gori, AM, Migliorini, A, Comito, V, Bellandi, B, Abbate, R, Gensini, GF & Antoniucci, D 2016, 'Bleeding events and maintenance dose of prasugrel: BLESS pilot study', Open Heart, vol. 3, no. 2, e000460. https://doi.org/10.1136/openhrt-2016-000460
Carrabba N, Parodi G, Marcucci R, Valenti R, Gori AM, Migliorini A et al. Bleeding events and maintenance dose of prasugrel: BLESS pilot study. Open Heart. 2016 Oct 1;3(2). e000460. https://doi.org/10.1136/openhrt-2016-000460
Carrabba, Nazario ; Parodi, Guido ; Marcucci, Rossella ; Valenti, Renato ; Gori, Anna Maria ; Migliorini, Angela ; Comito, Vincenzo ; Bellandi, Benedetta ; Abbate, Rosanna ; Gensini, Gian Franco ; Antoniucci, David. / Bleeding events and maintenance dose of prasugrel : BLESS pilot study. In: Open Heart. 2016 ; Vol. 3, No. 2.
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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.",
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AU - Gori, Anna Maria

AU - Migliorini, Angela

AU - Comito, Vincenzo

AU - Bellandi, Benedetta

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N2 - 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.

AB - 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.

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