DELHI: Dabigatran is at par with aspirin in the prevention of recurrent stroke in patients with a recent history of embolic stroke of undetermined source, according to a recent study. Cryptogenic strokes constitute 20 to 30% of ischemic strokes, and most cryptogenic strokes are considered to be embolic and of undetermined source.
The study, published in The New England Journal of Medicine, found that incidence of major bleeding was not greater in the dabigatran group than in the aspirin group, however, there were more clinically relevant nonmajor bleeding events in the dabigatran group.
Previous studies have shown that rivaroxaban is no longer effective than aspirin for recurrent stroke prevention after embolic stroke from an undetermined source. Hans-Christoph Diener, a professor of neurology at the University Duisburg-Essen and University Hospital Essen, Germany, and colleagues conducted this RE-SPECT ESUS trial to determine whether dabigatran is effective in preventing recurrent strokes after this type of stroke.
“Guidelines for secondary prevention of stroke in patients who have had a cryptogenic stroke recommend administration of antiplatelet agents, and treatment may include aspirin, a combination of extended-release dipyridamole and aspirin or clopidogrel and aspirin,” wrote the researchers. “Oral anticoagulants, including dabigatran etexilate, have an established role in reducing the incidence of recurrent strokes among patients with high-risk cardioembolic factors, such as atrial fibrillation.”
A total of 5390 patients were enrolled at 564 sites and were randomly assigned to receive dabigatran (2695 patients) at a dose of 150 mg or 110 mg twice daily or aspirin (2695 patients) at a dose of 100 mg once daily in patients who had an embolic stroke of undetermined source.
The primary outcome was a recurrent stroke. The primary safety outcome was major bleeding. Median follow-up was 19 months.
They found that:
- During a median follow-up of 19 months, recurrent strokes occurred in 177 patients (6.6%) in the dabigatran group (4.1% per year) and in 207 patients (7.7%) in the aspirin group (4.8% per year).
- Ischemic strokes occurred in 172 patients (4.0% per year) and 203 patients (4.7% per year), respectively.
- Major bleeding occurred in 77 patients (1.7% per year) in the dabigatran group and in 64 patients (1.4% per year) in the aspirin group.
- Clinically relevant nonmajor bleeding occurred in 70 patients (1.6% per year) and 41 patients (0.9% per year), respectively.
“In patients with a recent history of embolic stroke of undetermined source, dabigatran was not superior to aspirin in preventing recurrent stroke,” wrote the authors.
For detailed study log on to DOI: 10.1056/NEJMoa1813959