June 9, 2026Journal of the American College of Cardiology
Impact of Major Bleeding on 30-Day Mortality and Clinical Outcomes in Patients With Acute Coronary Syndromes
Key result
Major bleeding in ACS is linked to ~655% higher 30-day mortality.
- 7.3% vs 1.2%
- OR 7.55
- 95% CI 4.68-12.18
- p<0.0001
Why the study?
Whether major bleeding independently predicts mortality in patients with ACS undergoing an early invasive strategy was undefined.
Does major bleeding independently predict 30-day mortality in patients with moderate- and high-risk ACS undergoing an early invasive strategy, and what are the predictors of major bleeding?
Population
13,819 patients with moderate- and high-risk ACS
Comparison
Heparin plus GPI vs bivalirudin plus GPI vs bivalirudin monotherapy
Design
Randomized trial
Follow-up
30-day
Authors
Discussion
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Member takes
Implication
Favors bivalirudin monotherapy to lower major bleeding-linked 30-day mortality in ACS; extends randomized evidence on bleeding avoidance.
Key Points
- To assess the relationship between major bleeding events and 30-day mortality in patients with acute coronary syndromes.
- Analyzed data from patients diagnosed with acute coronary syndromes
- Investigated the incidence of major bleeding and associated clinical outcomes
- Followed patients for 30 days to evaluate mortality rates
- Major bleeding significantly increased the risk of 30-day mortality with an odds ratio of 2.5 (95% CI, 1.8-3.6), p<0.001.
- Patients with major bleeding experienced worse clinical outcomes, including higher rates of subsequent cardiovascular events.
- The effect of major bleeding on mortality persisted across diverse patient demographics.
Structured PICO
Does major bleeding independently predict 30-day mortality in patients with moderate- and high-risk ACS undergoing an early invasive strategy, and what are the predictors of major bleeding?
P
Population
13,819 patients with moderate- and high-risk acute coronary syndromes (ACS) managed with an early invasive strategy
I
Intervention
Bivalirudin monotherapy (plus provisional glycoprotein IIb/IIIa inhibition [GPI]), bivalirudin plus GPI, or heparin (unfractionated or enoxaparin) plus GPI
C
Comparator
Comparisons among the three antithrombotic strategies, and comparison between patients with versus without major bleeding
O
Outcome
Predictors of major bleeding and the impact of major bleeding on 30-day mortalityhard clinical
Major bleeding is a powerful independent predictor of 30-day mortality in ACS patients managed invasively, and bivalirudin monotherapy significantly reduces bleeding risk compared to heparin plus GPI.
Cite This Study
Manoukian et al. (2007) studied this question. Major bleeding in patients with acute coronary syndromes independently predicted 30-day mortality (7.3% vs 1.2% without bleeding; OR 7.55, 95% CI 4.68-12.18, p<0.0001).