Predictors of bleeding in patients with acute coronary syndromes treated with prasugrel
Key result
Prasugrel pretreatment increases 7-day non-CABG TIMI major bleeding risk by ~202% in NSTEMI patients.
- HR 3.02
- 95% CI 1.42 to 6.43
- n=4,033
Why the study?
Balancing the benefits of prasugrel antiplatelet therapy against bleeding risks in ACS patients requires identification of bleeding predictors.
What are the independent predictors of bleeding in patients with NSTEMI treated with prasugrel?
Population
4033 patients with NSTEMI
Comparison
30 mg prasugrel LD pretreatment vs placebo LD followed by 60 mg prasugrel at PCI
Design
Randomised placebo-controlled trial
Follow-up
7 days
Authors
Discussion
Loading...
Member takes
Implication
Supports avoiding prasugrel pretreatment in NSTEMI to curb bleeding; extends ACCOAST data on patient and procedural risk factors.
Study Design
Type
RCT (n=4,033)
Randomization
Randomized
Structured PICO
What are the independent predictors of bleeding in patients with NSTEMI treated with prasugrel?
P
Population
4,033 patients with non-ST-segment elevation myocardial infarction (NSTEMI) assessed for bleeding predictors over 7 days.
I
Intervention
30 mg prasugrel loading dose followed by coronary angiography with an additional 30 mg prasugrel at the time of percutaneous coronary intervention (PCI) (pretreatment)
C
Comparator
Placebo loading dose followed by a 60 mg prasugrel at the time of PCI
O
Outcome
Thrombolysis in Myocardial Infarction (TIMI) major bleeding not related to coronary artery bypass grafting (CABG) within 7 dayssafety
Main Result
Hazard Ratio: 3.02 (95% CI 1.42–6.43)
Pretreatment with prasugrel, femoral access, female sex, placement of multiple stents, and older age are independent predictors of increased bleeding risk in NSTEMI patients.
Cite This Study
Widimský et al. (2015) conducted an RCT in Non-ST-segment elevation myocardial infarction (NSTEMI) (n=4,033). Prasugrel pretreatment vs. Placebo loading dose followed by 60 mg prasugrel at the time of PCI was evaluated on Non-CABG-related TIMI major bleeding within 7 days (HR 3.02, 95% CI 1.42 to 6.43). Pretreatment with a prasugrel loading dose increased the risk of non-CABG-related TIMI major bleeding within 7 days in patients with NSTEMI (HR 3.02; 95% CI 1.42-6.43).