Assessment of Nonfatal Bleeding Events as a Surrogate for Mortality in Coronary Artery Disease
Authors' conclusion
We demonstrated a trial-defined bleeding event may not be a valid surrogate for mortality in RCTs investigating the effect of antithrombotic agents for coronary artery disease.
Study context
- Population
- Randomized controlled trials (RCTs) of antithrombotic agents in patients with CAD, through August 2022
- Participants
- 181,951 participants48 RCTs
- Comparison
- Treatment effect on nonfatal bleeding vs treatment effect on mortality
- Outcome
- Trial-level correlation (R2) between treatment effects on nonfatal bleeding events and mortality (all-cause or CV death)
Methodological detailstrial-level correlation analysis
- Trial-level correlation analysis
Pooled result
As reported in the abstract
Trial-level R2, major and minor bleeding vs mortality
Major and minor bleeding vs all-cause death: R2
0.09
95% CI 0.00–0.26
Major and minor bleeding vs CV death: R2
0.09
95% CI 0.00–0.27
Further pooled results
Trial-level R2, major bleeding only vs mortality
- Major bleeding vs all-cause death: R2
- 0.03 (95% CI 0.00-0.13)
- Major bleeding vs CV death: R2
- 0.01 (95% CI 0.00-0.05)
Subgroups by bleeding definition (BARC vs TIMI), study year, follow-up duration
- No subgroup analysis showed significant correlation
Original publication
Assessment of Nonfatal Bleeding Events as a Surrogate for Mortality in Coronary Artery Disease. JACC Adv. Published 20 February 2023. doi:10.
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