medwireNews: DOAC-CVT study findings support direct oral anticoagulants (DOACs) as a feasible treatment alternative to vitamin K antagonists (VKAs) for cerebral venous thrombosis (CVT).
The study aimed to address the lack of high-quality prospective data on the two treatments by comparing them “in a setting that reflects daily clinical practice,” say the authors.
Accordingly, between 2021 and 2024, Jonathan Coutinho (University of Amsterdam, the Netherlands) and colleagues included 619 patients in an observational study carried out at 65 hospitals in 23 countries across five continents. Eligible patients had radiologically confirmed CVT and started oral anticoagulant treatment within 30 days of being diagnosed, having not previously received such therapy.
The patients had a median age of 41 years and 63% of them were women. Most had been treated with lead-in heparin, and at a median 6 days after diagnosis, 401 (65%) received DOACs (67% dabigatran etexilate; 33% factor Xa inhibitors) and 218 (35%) received VKAs.
Data were collected at diagnosis and again at 3-, 6- and 12-month routine clinical visits, with a median follow-up of 186 and 187 days for the DOAC and VKA groups, respectively.
Writing in The Lancet Neurology, Coutinho and colleagues say that 12 (3%) of the DOAC patients and a comparable seven (3%) of the VKA patients experienced the composite outcome of symptomatic VTE or major bleeding events, giving a nonsignificant unadjusted odds ratio (OR) of 0.93. After inverse probability of treatment weighting to adjust for confounders, such as age, renal function, cancer, central nervous system infections, and previous major bleeding and venous thromboembolism (VTE), the OR was 0.99 with DOACs versus VKAs, at a risk difference of 0%.
Similarly, there was no difference in symptomatic recurrent VTE at 6 months among individuals with available data, occurring in 1% of patients in each group. Of these events, four and one, respectively, were new CVT events.
The team found that rates of major bleeding at 6 months were also comparable for the two treatment arms, occurring in 1% of patients given DOACs versus 2% of those given VKA. Of these, two cases in each group were an intracranial hemorrhage. And at the 6-month mark, 1% of patients in each group had died.
Among secondary outcomes at 6 months, there were clinically relevant nonmajor bleeding events in 2% and 1% of patients in the DOAC and VKA groups, respectively. Poor functional outcomes were less likely with DOACs than with VKAs, with 5% versus 7% of patients achieving modified Rankin Scale scores of 3–6 points out of a possible 6 points, where higher scores indicate greater disability. Two patients (<1%) versus one patient (<1%) had an arterial thrombotic event.
At follow-up imaging, undertaken a median of 181 days after CVT diagnosis, 82% of 278 patients and 85% of 138 patients achieved recanalization stage 2A or higher, defined as “at least partial recanalisation of all previously thrombosed vessels,” while complete recanalization was achieved in significantly fewer patients receiving DOACs than VKAs, at a respective 38% and 58%.
In a related editorial, Ana-Lucia Garcia Guarniz (The Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA) and colleagues say that “it is noteworthy that 11 of 12 patients with a primary outcome in the direct oral anticoagulant group received dabigatran etexilate […] whereas only one patient received a factor Xa inhibitor.”
They comment that “[t]hese small numbers of events preclude firm conclusions; however, taken together with findings from ACTION-CVT, they raise the question of whether factor Xa inhibitors might be preferable to vitamin K antagonists for managing cerebral venous thrombosis.”
Indeed, in an exploratory post-hoc primary endpoint analysis stratified by DOAC type, the weighted odds ratio for the composite outcome was a nonsignificant 1.54 for dabigatran etexilate versus VKAs and a nonsignificant 0.13 for factor Xa inhibitors versus VKAs.
The investigators conclude: “This study adds to the increasing weight of evidence that DOACs are a reasonable alternative treatment option to VKAs for CVT.”
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Lancet Neurol 2025; doi:10.1016/S1474-4422(24)00519-2
Lancet Neurol 2025; doi:10.1016/S1474-4422(25)00035-3
