In a recent publication in the journal Stroke, researchers conducted a multicenter, international retrospective study (United States, Europe, and New Zealand), which included consecutive patients with CVT treated with oral anticoagulation from January 2015 to December 2020. The objective of the study was to compare use of DOACs with the use of warfarin in a real-world working cohort of patients with CVT.
The researchers abstracted demographics and CVT risk factors, hypercoagulable laboratory results, baseline imaging data, and clinical and radiological outcomes from medical records. They also used adjusted inverse probability of treatment–weighted Cox-regression models to compare recurrent cerebral or systemic venous thrombosis, death, and major hemorrhage in patients treated with warfarin versus DOACs. Researchers also performed adjusted inverse probability of treatment–weighted logistic regression to compare recanalization rates on follow-up imaging across the two treatment groups.
Findings from the study indicated that among 1,025 CVT patients across 27 centers, 845 patients met the inclusion criteria. The average age was 44.8 years, and 64.7% were women; 33.0% received DOAC only, 51.8% received warfarin only, and 15.1% received both treatments at different times. During a median follow-up of 345 (interquartile range, 140-720) days, there were 5.68 recurrent venous thromboses, 3.77 major hemorrhages, and 1.84 deaths per 100 patient-years.
Among 525 patients who met recanalization analysis inclusion criteria, 36.6% had complete, 48.2% had partial, and 15.2% had no recanalization. When compared with warfarin, DOAC treatment was linked with comparable risk of recurrent venous thrombosis (adjusted hazard ratio [aHR], 0.94 [95% CI, 0.51-1.73]; P = .84), death (aHR, 0.78 [95% CI, 0.22-2.76]; P = .70), and rate of partial/complete recanalization (aHR, 0.92 [95% CI, 0.48-1.73]; P = .79) but a lower risk of major hemorrhage (aHR, 0.35 [95% CI, 0.15-0.82]; P = .02).
The authors concluded that in patients with CVT, treatment with DOACs was correlated with comparable clinical and radiographic outcomes and favorable safety profiles compared with warfarin treatment. They also noted that their findings require confirmation by large prospective or randomized studies.
Findings from this study were presented at the recent 2022 International Stroke Conference. Ekaterina Bakradze, assistant professor of neurology at the University of Alabama at Birmingham and one of the authors of the study, stated, "This real-world data supports use of direct oral anticoagulant drugs as a reasonable alternative to warfarin in patients with cerebral venous thrombosis."
Dr. Bakradze also noted that since this study was based on retrospective observational data, the findings should be interpreted with caution and warrant confirmation by larger prospective studies.
Two such studies are now underway: the Direct Oral Anticoagulants in the Treatment of Cerebral Venous Thrombosis study and the randomized Study of Rivaroxaban for Cerebral Venous Thrombosis trial.
In an editorial accompanying the publication in Stroke, Johnathon Gorman, MD, and Thalia Field, MD, from the Vancouver Stroke Program at the University of British Columbia, noted, "Despite its methodological limitations, the ACTION-CVT [Rivarobaxan Compared to Warfarin for Treatment of CVT] study provides added value to the current state of knowledge by virtue of its size and 'real world' setting that is reflective of how DOACs are being used to manage CVT in current clinical practice."
They also noted that although baseline characteristics between the DOAC and warfarin groups were comparable, the possibility of confounding cannot be excluded, and "other characteristics not easily captured in a retrospective study may sway anticoagulation strategy." Lastly, the editorialists concluded that ACTION-CVT gives additional reassurance for DOACs as an alternative approach to warfarin as a treatment for CVT and for the shifts in clinical practice that are already occurring at many centers.
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