Direct oral anticoagulants increase bleeding risk after intracerebral hemorrhage in patients with atrial fibrillation

1. Ischemic stroke occurred less often in patients with atrial fibrillation on DOACs compared to those on placebo.

2. Patients in the DOAC group reported an increased risk of intracerebral hemorrhage.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Patients with atrial fibrillation are often prescribed direct oral anticoagulants (DOACs) to reduce the risks of thromboembolism and stroke. However, the safety and efficacy of restarting anticoagulation after spontaneous intracerebral hemorrhage (ICH) remains uncertain. This randomized controlled trial aimed to determine whether DOACs could reduce the risk of ischemic stroke without significantly increasing the risk of recurrent ICH in this high-risk population. The primary outcome was first occurrence of ischemic stroke, while key secondary outcome was recurrence of ICH. According to study results, DOACs significantly lowered the risk of ischemic stroke compared to no anticoagulation; however, they were also associated with a higher risk of recurrent ICH. Although this study was well done, it was limited by a small sample size, which may affect the generalizability of its findings.

Click to read the study in The Lancet

Relevant Reading: Early versus Later Anticoagulation for Stroke with Atrial Fibrillation

In-depth [randomized controlled trial]: Between May 31, 2019, and Nov 30, 2023, 327 patients were assessed for eligibility across 75 hospitals in 6 European countries. Included were patients ≥ 18 years with spontaneous ICH, a clinical diagnosis of atrial fibrillation, and a modified Rankin Scale score ≤ 4. Altogether, 319 patients (158 in DOAC group and 161 in no anticoagulant group) were included in the final analysis. The primary outcome of ischemic stroke occurred significantly less often in the DOAC group (hazard ratio [HR] 0.05, 95% confidence interval [CI] 0.01-0.36, log-rank p<0.0001). The secondary outcome of recurrent ICH occurred more frequently in the DOAC group (event rate 5.00 per 100 patient-years in DOAC vs. 0.82 per 100 patient-years in placebo). Findings from this study suggest that while DOACs reduce the risk of ischemic stroke in patients with atrial fibrillation, they increase bleeding.

Image: PD

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