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Direct oral anticoagulants (DOACs) showed promise in the treatment of cerebral venous thrombosis (CVT), the observational ACTION-CVT study found.

Efficacy and radiographic outcomes appeared similar between DOAC users and warfarin users in four countries:

• Recurrent venous thrombosis (venous thromboembolism or CVT): 5.26 per 100 patient-years on DOAC vs 5.87 per 100 patient-years on warfarin (adjusted HR 0.94, 95% CI 0.51-1.73)
• Death: 1.81 vs 1.90 per 100 patient-years (adjusted HR 0.71, 95% CI 0.24-2.08)
• Partial or complete recanalization: 86.0% vs 84.1% (adjusted OR 0.92, 95% CI 0.48-1.73; excluding people who underwent endovascular treatment)

As for safety, however, rates of major hemorrhage favored DOAC treatment over a median 345 days of follow-up (2.44 vs 4.70 per 100 patient-years; adjusted HR 0.35, 95% CI 0.15-0.81), reported Ekaterina Bakradze, MD, of the University of Alabama at Birmingham, during the American Stroke Association's International Stroke Conference. The full study was .

Although study findings suggested that DOACs may be a reasonable alternative to warfarin in patients with CVT, Bakradze and colleagues warned that this will need to be confirmed in large prospective or randomized studies such as and .

"These data will provide additional information to better inform clinical decision-making and provide higher levels of evidence to support future management guidelines for CVT," agreed Johnathon Gorman, MD, and Thalia Field, MD, both of the Vancouver Stroke Program at the University of British Columbia. Field is the principal investigator of the ongoing SECRET trial.

"In the interim, ACTION-CVT gives additional reassurance to accompany the shifts in clinical practice that are already occurring at many centres," the pair wrote in .

One caveat is that DOACs are generally more expensive than warfarin, so cost-effectiveness may be an issue, the study authors suggested.

ACTION-CVT was a retrospective study of CVT patients given oral anticoagulation at one of 27 large stroke centers across the U.S., Italy, Switzerland, and New Zealand. Pregnant people, cancer patients, and other groups had been excluded because the researchers deemed that there was no equipoise between anticoagulant options for these patients.

Out of 1,025 consecutive patients screened in 2010 to 2015, 845 met inclusion criteria. This cohort had a mean age of 44.8 years, and 64.7% were women.

Oral anticoagulation came in the form of warfarin only for 51.8% of patients, a DOAC only for 33.0%, and a mix of the two at different times for 15.1%. In the DOAC group, patients were most commonly on apixaban (Eliquis; 66.6%), followed by rivaroxaban (Xarelto; 18.2%), and dabigatran (Pradaxa; 13.5%).

DOAC and warfarin groups were well matched in most baseline characteristics, except the former had more history of VTE, fewer people testing positive for antiphospholipid antibodies, and a lower likelihood of being treated with low-molecular-weight heparin.

The observational study was subject to potential confounding and limited by a lack of central blinded adjudication of clinical and imaging outcomes. Furthermore, a relatively high 15.7% of patients were lost to follow-up within 90 days, Bakradze acknowledged.

However, the low incidence of CVT makes large randomized controlled trials challenging to conduct. The previous trial had been underpowered to show differences between dabigatran and warfarin in CVT.