Early bleeding within 90 days in patients with CAD and AF was not significantly associated with subsequent ischemic events (HR 1.80; 95% CI 0.131-10.32; P=0.509).
RCT (n=1,029)
Does early bleeding increase the risk of subsequent ischemic events in patients with coronary artery disease and atrial fibrillation?
In patients with CAD and AF, early bleeding within 90 days of starting therapy is associated with a markedly increased subsequent risk of myocardial infarction and unplanned revascularization, highlighting the need for close monitoring.
Effect estimate: HR 1.80 (95% CI 0.131-10.32)
p-value: p=0.509
Abstract Background Bleeding events are common in patients with coronary artery disease (CAD) and atrial fibrillation (AF) receiving antithrombotic therapy and are known to be associated with an increased risk of clinical outcomes. We aimed to evaluate the impact of early bleeding on subsequent adverse clinical events using data from the EPIC-CAD trial. Methods In this subgroup analysis, patients with at least three months of follow-up were included. Of the original 1,040 patients, 11 who died within 90 days and were lost to follow-up were excluded, resulting in a final analytic cohort of 1,029 patients. Baseline characteristics and clinical outcomes were compared between those with early bleeding (N=61) and those without early bleeding (N=968). Early bleeding was defined as any degree of bleeding occurring within 90 days after randomization. The primary study outcomes were ischemic events (death, ischemic stroke, myocardial infarction, and urgent repeat revascularization) that occurred after early bleeding. A time-dependent Cox hazard model was applied to evaluate the association between early bleeding and subsequent clinical outcomes. Results Patients with early bleeding were more likely to receive dual antithrombotic therapy, had lower creatinine clearance, and higher HAS-BLED scores compared with those without early bleeding. Overall, early bleeding was not associated with ischemic (HR 1.80, 95% CI 0.131-10.32, P=0.509) or bleeding events (HR 2.09, 95% CI 0.55 – 8.00, P=0.282). However, in a detailed sub-analysis, patients with early bleeding had a higher risk of myocardial infarction (HR: 16.405, 95% CI: 1.026–262.386, p = 0.048) and unplanned urgent revascularization (HR: 4.544, 95% CI: 1.060–19.476, p = 0.041) compared with those without early bleeding. No significant association was observed between early bleeding events and subsequent mortality. Conclusion Early bleeding events within 90 days are associated with an increased risk of myocardial infarction and unplanned revascularization, but not with higher mortality at 12 months. Close monitoring and managing modifiable risk factors should be warranted for those patients with early bleeding.
An et al. (2025) conducted an RCT in Coronary artery disease and atrial fibrillation (n=1,029). Early bleeding (within 90 days after randomization) vs. No early bleeding was evaluated on Ischemic events (death, ischemic stroke, myocardial infarction, and urgent repeat revascularization) that occurred after early bleeding (HR 1.80, 95% CI 0.131-10.32, p=0.509). Early bleeding within 90 days in patients with CAD and AF was not significantly associated with subsequent ischemic events (HR 1.80; 95% CI 0.131-10.32; P=0.509).
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