May 24, 2011Circulation
Predictors of Bleeding and Time Dependence of Association of Bleeding With Mortality
Why the study?
What are the predictors of serious bleeding and its time-dependent association with mortality in patients with acute coronary syndromes?
Population
13,420 patients with acute coronary syndromes from the TRITON-TIMI 38 trial
Design
Cohort
Authors
Discussion
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Member takes
Implication
May warrant intensified early surveillance after serious bleeding in ACS; hypothesis-generating for time-limited interventions to mitigate mortality risk.
Key Points
- To identify baseline and procedural predictors of serious bleeding and evaluate the time-dependent relationship between bleeding events and subsequent mortality in patients with acute coronary syndromes.
- Conducted a secondary analysis of the TRITON-TIMI 38 randomized clinical trial (N=13,420; NCT00097591) in patients with acute coronary syndromes.
- Used multivariable Cox regression adjusted for treatment, baseline, and procedural factors to identify predictors of TIMI major or minor bleeding.
- Performed iterative day-to-day landmark analyses to assess the time-dependent hazard of serious bleeding on all-cause mortality.
- A serious bleeding event occurred in 534 patients (4.0%), with major predictors including female sex, glycoprotein IIb/IIIa inhibitor use, duration of intervention, older age, prasugrel assignment, STEMI diagnosis, femoral access, and reduced creatinine clearance.
- Serious bleeding was associated with a significant increase in mortality (adjusted HR 5.84, 95% CI 4.11 to 8.29).
- The elevated risk of death was concentrated within the initial post-bleed period and did not differ statistically from baseline risk after 40 days.
Structured PICO
What are the predictors of serious bleeding and its time-dependent association with mortality in patients with acute coronary syndromes?
P
Population
13,420 patients with acute coronary syndromes from the TRITON-TIMI 38 trial
O
Outcome
Serious (TIMI major or minor) bleeding and subsequent mortalitysafety
Serious bleeding in ACS patients is strongly associated with mortality within the first 40 days, driven by a combination of patient, procedural, and antiplatelet factors.
Cite This Study
Hochholzer et al. (2011) studied this question.