Petr Widimsky1, Zuzana Motovska1, Leonardo Bolognese2, Dariusz Dudek3, Christian Hamm4, Jean-Francois Tanguay5, Jurrien Ten Berg6, Eileen Brown7, LeRoy LeNarz7, Debra L Miller7, Gilles Montalescot8. 1. Cardiocenter, Third Faculty of Medicine, Charles University Prague, Prague, Czech Republic. 2. Cardiovascular and Neurological Department Azienda Ospedaliera, Arezzo, Italy. 3. Institute of Cardiology, Jagiellonian University Medical College, University Hospital, Krakow, Poland. 4. Kerckhoff Heart and Thoraxcenter, Bad Nauheim and Medical Clinic I, University of Giessen Germany, Bad Nauheim, Germany. 5. MD Interventional Cardiology and Research Program, Université de Montréal, Montreal, Quebec, Canada. 6. Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands. 7. Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA. 8. Institut de Cardiologie, Centre Hospitalier Universitaire Pitié-Salpêtriėre (ACTION Study Group, AP-HP, Université Paris 6), Paris, France.
Abstract
BACKGROUND: When considering antiplatelet therapy for acute coronary syndrome (ACS), it is essential to balance benefits (less thrombotic/ischaemic events) versus bleeding risks related to intense platelet inhibition via antagonism of P2Y12 receptors. This analysis aimed to identify predictors of bleeding events among A Comparison of Prasugrel at the Time of PCI or as Pretreatment at the Time of Diagnosis in Patients with NSTEACS (ACCOAST) study population. METHODS AND RESULTS: The ACCOAST study randomised 4033 patients with non-ST-segment elevation myocardial infarction (NSTEMI) to (A) a 30 mg prasugrel loading dose (LD) followed by coronary angiography with an additional 30 mg prasugrel at the time of percutaneous coronary intervention (PCI) or (B) a placebo LD followed by a 60 mg prasugrel at the time of PCI. Patients received standard of care, including use of aspirin. Independent predictors of Thrombolysis in Myocardial Infarction (TIMI) major bleeding not related to coronary artery bypass grafting (CABG) within 7 days were assessed using stepwise Cox proportional model for time to first occurrence of the event. Non-CABG-related TIMI major or minor bleeding was similarly analysed. Non-CABG-related TIMI major bleeding occurred in 36 (0.9%) patients, and TIMI major or minor bleeding occurred in 81 (2.0%) patients. Independent predictors for TIMI major bleeding alone were pretreatment with prasugrel LD (HR 3.02; 95% CI 1.42 to 6.43), femoral access (HR 2.45; 95% CI 1.11 to 5.38), female sex (HR 2.57; 95% CI 1.32 to 5.00), placement of >1 stent (HR 2.50; 95% CI 1.26 to 4.95) and age (HR 1.05; 95% CI 1.02 to 1.09). Pretreatment with prasugrel LD (HR 3.05; 95% CI 1.84 to 5.07), femoral access (HR 3.06; 95% CI 1.74 to 5.38), female sex (HR 2.62; 95% CI 1.67 to 4.12), performed PCI (HR 2.21; 95% CI 1.23 to 3.99), therapy with glycoprotein IIb/IIIa inhibitors (HR 1.88; 95% CI 1.06 to 3.33) and age (increased bleed per year of age HR 1.04; 95% CI 1.02 to 1.06) were independent predictors of TIMI major or minor bleeding through 7 days. CONCLUSIONS: Pretreatment, age, gender and procedural variables predicted bleeding risk in patients with NSTEMI. CLINICAL REGISTRATION NO: NCT01015287. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
BACKGROUND: When considering antiplatelet therapy for acute coronary syndrome (ACS), it is essential to balance benefits (less thrombotic/ischaemic events) versus bleeding risks related to intense platelet inhibition via antagonism of P2Y12 receptors. This analysis aimed to identify predictors of bleeding events among A Comparison of Prasugrel at the Time of PCI or as Pretreatment at the Time of Diagnosis in Patients with NSTEACS (ACCOAST) study population. METHODS AND RESULTS: The ACCOAST study randomised 4033 patients with non-ST-segment elevation myocardial infarction (NSTEMI) to (A) a 30 mg prasugrel loading dose (LD) followed by coronary angiography with an additional 30 mg prasugrel at the time of percutaneous coronary intervention (PCI) or (B) a placebo LD followed by a 60 mg prasugrel at the time of PCI. Patients received standard of care, including use of aspirin. Independent predictors of Thrombolysis in Myocardial Infarction (TIMI) major bleeding not related to coronary artery bypass grafting (CABG) within 7 days were assessed using stepwise Cox proportional model for time to first occurrence of the event. Non-CABG-related TIMI major or minor bleeding was similarly analysed. Non-CABG-related TIMI major bleeding occurred in 36 (0.9%) patients, and TIMI major or minor bleeding occurred in 81 (2.0%) patients. Independent predictors for TIMI major bleeding alone were pretreatment with prasugrel LD (HR 3.02; 95% CI 1.42 to 6.43), femoral access (HR 2.45; 95% CI 1.11 to 5.38), female sex (HR 2.57; 95% CI 1.32 to 5.00), placement of >1 stent (HR 2.50; 95% CI 1.26 to 4.95) and age (HR 1.05; 95% CI 1.02 to 1.09). Pretreatment with prasugrel LD (HR 3.05; 95% CI 1.84 to 5.07), femoral access (HR 3.06; 95% CI 1.74 to 5.38), female sex (HR 2.62; 95% CI 1.67 to 4.12), performed PCI (HR 2.21; 95% CI 1.23 to 3.99), therapy with glycoprotein IIb/IIIa inhibitors (HR 1.88; 95% CI 1.06 to 3.33) and age (increased bleed per year of age HR 1.04; 95% CI 1.02 to 1.06) were independent predictors of TIMI major or minor bleeding through 7 days. CONCLUSIONS: Pretreatment, age, gender and procedural variables predicted bleeding risk in patients with NSTEMI. CLINICAL REGISTRATION NO: NCT01015287. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Lena Mathews; Junichi Ishigami; Ning Ding; Ron C Hoogeveen; Anna Kucharska-Newton; Christie M Ballantyne; Rebecca Gottesman; Elizabeth Selvin; Kunihiro Matsushita Journal: J Am Heart Assoc Date: 2020-03-02 Impact factor: 5.501
Authors: T Yetgin; E Boersma; P C Smits; A G de Vries; E Huijskens; F Zijlstra; M M J M van der Linden; R J M van Geuns Journal: Neth Heart J Date: 2018-08 Impact factor: 2.380