Abstract Body: BACKGROUND
Survivors of spontaneous intracerebral hemorrhage (ICH) who also suffer from atrial fibrillation (AF) are at high risk of both ischemic stroke and recurrent intracerebral hemorrhage. Whether subsequent strokes in these patients should be prevented with oral anticoagulants is an unresolved dilemma. We conducted a randomized controlled trial (RCT) to address this question.
METHODS
We randomly assigned, in a 1:1 ratio, patients with ICH and AF to either receive a direct oral anticoagulant (DOAC) or no anticoagulation (either antiplatelet or no antithrombotic medication). The earliest time point of starting study drug was 14 days after ICH. Patients were followed-up for a maximum of 3 years. The primary end point was ischemic stroke, the co-primary endpoint was recurrent ICH. The secondary endpoints include all stroke and systemic embolism, all-cause mortality, cardiovascular mortality, major adverse cardiac events, and net clinical benefit.
RESULTS
A total of 158 patients were assigned to receive a DOAC, and 161 to receive no OAC. The mean age of patients was 78.0+/-7.9 years and 65% of patients were male. During a mean follow-up of 17 months no patient was lost to follow-up. Data bank is closed and main efficacy and safety results will be available in December 2024.
CONCLUSIONS
PRESTIGE-AF is expected to be a sufficiently powered RCT to answer the question whether DOAC can prevent ischemic strokes in survivors of ICH with comorbid AF, and whether this putative benefit is substantially reduced by an increased risk of recurrent ICH.
(Funded by European Commission HORIZON2020 grant agreement No. 754517 ClinicalTrials.gov NCT03996772)