Direct Oral Anticoagulants Versus Warfarin in the Treatment of Cerebral Venous Thrombosis (ACTION-CVT): A Multicenter International Study

Shadi Yaghi, Department of Neurology, Brown University, Providence, RI (S.Y., L.S., C.S., N.K., S.E.J., A.C., S.C., K.F.).
Liqi Shu, Department of Neurology, Brown University, Providence, RI (S.Y., L.S., C.S., N.K., S.E.J., A.C., S.C., K.F.).
Ekaterina Bakradze, Department of Neurology, University of Alabama at Birmingham (E.B.).
Setareh Salehi Omran, Department of Neurology, University of Colorado School of Medicine, Aurora (S.S.O.).
James A. Giles, Department of Neurology, Washington University, Saint Louis, MO (J.A.G., J.Y.A.).
Jordan Y. Amar, Department of Neurology, Washington University, Saint Louis, MO (J.A.G., J.Y.A.).
Nils Henninger, Department of Neurology (N.H., M.E.), University of Massachusetts, Worcester.
Marwa Elnazeir, Department of Neurology (N.H., M.E.), University of Massachusetts, Worcester.
Ava L. Liberman, Department of Neurology, Weill Cornell Medical Center, NY (A.L.L.).
Khadean Moncrieffe, Department of Neurology, Montefiore Medical Center, NY (K.M., J.L.).
Jenny Lu, Department of Neurology, Montefiore Medical Center, NY (K.M., J.L.).
Richa Sharma, Department of Neurology, Yale University, New Haven, CT (R.S., Y.C., A.S.Z., A.d.H.).
Yee Cheng, Department of Neurology, Yale University, New Haven, CT (R.S., Y.C., A.S.Z., A.d.H.).
Adeel S. Zubair, Department of Neurology, Yale University, New Haven, CT (R.S., Y.C., A.S.Z., A.d.H.).
Alexis N. Simpkins, Department of Neurology, University of Florida, Gainesville (A.N.S., G.T.L., J.C.K., D.P.).
Grace T. Li, Department of Neurology, University of Florida, Gainesville (A.N.S., G.T.L., J.C.K., D.P.).
Justin Chi Kung, Department of Neurology, University of Florida, Gainesville (A.N.S., G.T.L., J.C.K., D.P.).
Dezaray Perez, Department of Neurology, University of Florida, Gainesville (A.N.S., G.T.L., J.C.K., D.P.).
Mirjam Heldner, Department of Neurology, Inselspital Universitätsspital, Bern, Switzerland (M.H., A.S., D.S., B.S.).
Adrian Scutelnic, Department of Neurology, Inselspital Universitätsspital, Bern, Switzerland (M.H., A.S., D.S., B.S.).
David Seiffge, Department of Neurology, Inselspital Universitätsspital, Bern, Switzerland (M.H., A.S., D.S., B.S.).
Bernhard Siepen, Department of Neurology, Inselspital Universitätsspital, Bern, Switzerland (M.H., A.S., D.S., B.S.).
Aaron Rothstein, Department of Neurology, University of Pennsylvania, Philadelphia, PA (A.R., O.K., D.D.).
Ossama Khazaal, Department of Neurology, University of Pennsylvania, Philadelphia, PA (A.R., O.K., D.D.).
David Do, Department of Neurology, University of Pennsylvania, Philadelphia, PA (A.R., O.K., D.D.).
Sami Al Kasab, Department of Neurology (S.A.K., L.A.R.), Medical University of South Carolina, Charleston.
Line Abdul Rahman, Department of Neurology (S.A.K., L.A.R.), Medical University of South Carolina, Charleston.
Eva A. Mistry, Department of Neurology and Rehabilitation Medicine, University of Cincinnati (E.A.M., P.K., Y.A., B.C.).
Deborah Kerrigan, Department of Neurology, Vanderbilt University, Nashville, TN (D.K., H.L.).
Hayden Lafever, Department of Neurology, Vanderbilt University, Nashville, TN (D.K., H.L.).
Thanh N. Nguyen, Department of Neurology, Boston University School of Medicine, MA (T.N.N., P.K., H.A.).
Piers Klein, Department of Neurology and Rehabilitation Medicine, University of Cincinnati (E.A.M., P.K., Y.A., B.C.).

Document Type

Journal Article

Publication Date

3-1-2022

Journal

Stroke

Volume

53

Issue

3

DOI

10.1161/STROKEAHA.121.037541

Keywords

anticoagulants; contraindications; dabigatran; hemorrhage; venous thrombosis

Abstract

BACKGROUND: A small randomized controlled trial suggested that dabigatran may be as effective as warfarin in the treatment of cerebral venous thrombosis (CVT). We aimed to compare direct oral anticoagulants (DOACs) to warfarin in a real-world CVT cohort. METHODS: This multicenter international retrospective study (United States, Europe, New Zealand) included consecutive patients with CVT treated with oral anticoagulation from January 2015 to December 2020. We abstracted demographics and CVT risk factors, hypercoagulable labs, baseline imaging data, and clinical and radiological outcomes from medical records. We 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. We performed adjusted inverse probability of treatment weighted logistic regression to compare recanalization rates on follow-up imaging across the 2 treatments groups. RESULTS: Among 1025 CVT patients across 27 centers, 845 patients met our inclusion criteria. Mean age was 44.8 years, 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 thrombosis, 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 associated with similar risk of recurrent venous thrombosis (aHR, 0.94 [95% CI, 0.51-1.73]; =0.84), death (aHR, 0.78 [95% CI, 0.22-2.76]; =0.70), and rate of partial/complete recanalization (aOR, 0.92 [95% CI, 0.48-1.73]; =0.79), but a lower risk of major hemorrhage (aHR, 0.35 [95% CI, 0.15-0.82]; =0.02). CONCLUSIONS: In patients with CVT, treatment with DOACs was associated with similar clinical and radiographic outcomes and favorable safety profile when compared with warfarin treatment. Our findings need confirmation by large prospective or randomized studies.

Department

Neurology

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