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

Shadi Yaghi; Liqi Shu; Ekaterina Bakradze; Setareh Salehi Omran; James A. Giles; Jordan Y. Amar; Nils Henninger; Marwa Elnazeir; Ava L. Liberman; Khadean Moncrieffe; Jenny Lu; Richa Sharma; Yee Cheng; Adeel S. Zubair; Alexis N. Simpkins; Grace T. Li; Justin Chi Kung; Dezaray Perez; Mirjam Heldner; Adrian Scutelnic; David Seiffge; Bernhard Siepen; Aaron Rothstein; Ossama Khazaal; David Do; Sami Al Kasab; Line Abdul Rahman; Eva A. Mistry; Deborah Kerrigan; Hayden Lafever; Thanh N. Nguyen; Piers Klein; Hugo Aparicio; Jennifer Frontera; Lindsey Kuohn; Shashank Agarwal; Christoph Stretz; Narendra Kala; Sleiman El Jamal; Alison Chang; Shawna Cutting; Han Xiao; Adam De Havenon; Varsha Muddasani; Teddy Wu; Duncan Wilson; Amre Nouh; Syed Daniyal Asad; Abid Qureshi; Justin Moore; Pooja Khatri; Yasmin Aziz; Bryce Casteigne; Muhib Khan; Yao Cheng; Brian Mac Grory; Martin Weiss; Dylan Ryan; Maria Cristina Vedovati; Maurizio Paciaroni; James E. Siegler; Scott Kamen; Siyuan Yu; Christopher R. Leon Guerrero; Eugenie Atallah; Gian Marco De Marchis; Alex Brehm; Tolga Dittrich; Marios Psychogios; Ronald Alvarado-Dyer; Tareq Kass-Hout; Shyam Prabhakaran; Tristan Honda; David S. Liebeskind; Karen Furie

doi:10.1161/STROKEAHA.121.037541

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

Shadi Yaghi, Liqi Shu, Ekaterina Bakradze, Setareh Salehi Omran, James A. Giles, Jordan Y. Amar, Nils Henninger, Marwa Elnazeir, Ava L. Liberman, Khadean Moncrieffe, Jenny Lu, Richa Sharma, Yee Cheng, Adeel S. Zubair, Alexis N. Simpkins, Grace T. Li, Justin Chi Kung, Dezaray Perez, Mirjam Heldner, Adrian ScutelnicDavid Seiffge, Bernhard Siepen, Aaron Rothstein, Ossama Khazaal, David Do, Sami Al Kasab, Line Abdul Rahman, Eva A. Mistry, Deborah Kerrigan, Hayden Lafever, Thanh N. Nguyen, Piers Klein, Hugo Aparicio, Jennifer Frontera, Lindsey Kuohn, Shashank Agarwal, Christoph Stretz, Narendra Kala, Sleiman El Jamal, Alison Chang, Shawna Cutting, Han Xiao, Adam De Havenon, Varsha Muddasani, Teddy Wu, Duncan Wilson, Amre Nouh, Syed Daniyal Asad, Abid Qureshi, Justin Moore, Pooja Khatri, Yasmin Aziz, Bryce Casteigne, Muhib Khan, Yao Cheng, Brian Mac Grory, Martin Weiss, Dylan Ryan, Maria Cristina Vedovati, Maurizio Paciaroni, James E. Siegler, Scott Kamen, Siyuan Yu, Christopher R. Leon Guerrero, Eugenie Atallah, Gian Marco De Marchis, Alex Brehm, Tolga Dittrich, Marios Psychogios, Ronald Alvarado-Dyer, Tareq Kass-Hout, Shyam Prabhakaran, Tristan Honda, David S. Liebeskind, Karen Furie

Neurology

Research output: Contribution to journal › Article › peer-review

51 Scopus citations

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]; P=0.84), death (aHR, 0.78 [95% CI, 0.22-2.76]; P=0.70), and rate of partial/complete recanalization (aOR, 0.92 [95% CI, 0.48-1.73]; P=0.79), but a lower risk of major hemorrhage (aHR, 0.35 [95% CI, 0.15-0.82]; P=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.

Original language	English (US)
Pages (from-to)	728-738
Number of pages	11
Journal	Stroke
Volume	29
Issue number	2
DOIs	https://doi.org/10.1161/STROKEAHA.121.037541
State	Published - Mar 1 2022

Keywords

anticoagulants
contraindications
dabigatran
hemorrhage
venous thrombosis

ASJC Scopus subject areas

Clinical Neurology
Cardiology and Cardiovascular Medicine
Advanced and Specialized Nursing

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10.1161/STROKEAHA.121.037541

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Yaghi, S., Shu, L., Bakradze, E., Salehi Omran, S., Giles, J. A., Amar, J. Y., Henninger, N., Elnazeir, M., Liberman, A. L., Moncrieffe, K., Lu, J., Sharma, R., Cheng, Y., Zubair, A. S., Simpkins, A. N., Li, G. T., Kung, J. C., Perez, D., Heldner, M., ... Furie, K. (2022). Direct Oral Anticoagulants Versus Warfarin in the Treatment of Cerebral Venous Thrombosis (ACTION-CVT): A Multicenter International Study. Stroke, 29(2), 728-738. https://doi.org/10.1161/STROKEAHA.121.037541

Yaghi, S, Shu, L, Bakradze, E, Salehi Omran, S, Giles, JA, Amar, JY, Henninger, N, Elnazeir, M, Liberman, AL, Moncrieffe, K, Lu, J, Sharma, R, Cheng, Y, Zubair, AS, Simpkins, AN, Li, GT, Kung, JC, Perez, D, Heldner, M, Scutelnic, A, Seiffge, D, Siepen, B, Rothstein, A, Khazaal, O, Do, D, Kasab, SA, Rahman, LA, Mistry, EA, Kerrigan, D, Lafever, H, Nguyen, TN, Klein, P, Aparicio, H, Frontera, J, Kuohn, L, Agarwal, S, Stretz, C, Kala, N, El Jamal, S, Chang, A, Cutting, S, Xiao, H, De Havenon, A, Muddasani, V, Wu, T, Wilson, D, Nouh, A, Asad, SD, Qureshi, A, Moore, J, Khatri, P, Aziz, Y, Casteigne, B, Khan, M, Cheng, Y, Mac Grory, B, Weiss, M, Ryan, D, Vedovati, MC, Paciaroni, M, Siegler, JE, Kamen, S, Yu, S, Leon Guerrero, CR, Atallah, E, De Marchis, GM, Brehm, A, Dittrich, T, Psychogios, M, Alvarado-Dyer, R, Kass-Hout, T, Prabhakaran, S, Honda, T, Liebeskind, DS & Furie, K 2022, 'Direct Oral Anticoagulants Versus Warfarin in the Treatment of Cerebral Venous Thrombosis (ACTION-CVT): A Multicenter International Study', Stroke, vol. 29, no. 2, pp. 728-738. https://doi.org/10.1161/STROKEAHA.121.037541

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

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]; P=0.84), death (aHR, 0.78 [95% CI, 0.22-2.76]; P=0.70), and rate of partial/complete recanalization (aOR, 0.92 [95% CI, 0.48-1.73]; P=0.79), but a lower risk of major hemorrhage (aHR, 0.35 [95% CI, 0.15-0.82]; P=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.",

keywords = "anticoagulants, contraindications, dabigatran, hemorrhage, venous thrombosis",

author = "Shadi Yaghi and Liqi Shu and Ekaterina Bakradze and {Salehi Omran}, Setareh and Giles, {James A.} and Amar, {Jordan Y.} and Nils Henninger and Marwa Elnazeir and Liberman, {Ava L.} and Khadean Moncrieffe and Jenny Lu and Richa Sharma and Yee Cheng and Zubair, {Adeel S.} and Simpkins, {Alexis N.} and Li, {Grace T.} and Kung, {Justin Chi} and Dezaray Perez and Mirjam Heldner and Adrian Scutelnic and David Seiffge and Bernhard Siepen and Aaron Rothstein and Ossama Khazaal and David Do and Kasab, {Sami Al} and Rahman, {Line Abdul} and Mistry, {Eva A.} and Deborah Kerrigan and Hayden Lafever and Nguyen, {Thanh N.} and Piers Klein and Hugo Aparicio and Jennifer Frontera and Lindsey Kuohn and Shashank Agarwal and Christoph Stretz and Narendra Kala and {El Jamal}, Sleiman and Alison Chang and Shawna Cutting and Han Xiao and {De Havenon}, Adam and Varsha Muddasani and Teddy Wu and Duncan Wilson and Amre Nouh and Asad, {Syed Daniyal} and Abid Qureshi and Justin Moore and Pooja Khatri and Yasmin Aziz and Bryce Casteigne and Muhib Khan and Yao Cheng and {Mac Grory}, Brian and Martin Weiss and Dylan Ryan and Vedovati, {Maria Cristina} and Maurizio Paciaroni and Siegler, {James E.} and Scott Kamen and Siyuan Yu and {Leon Guerrero}, {Christopher R.} and Eugenie Atallah and {De Marchis}, {Gian Marco} and Alex Brehm and Tolga Dittrich and Marios Psychogios and Ronald Alvarado-Dyer and Tareq Kass-Hout and Shyam Prabhakaran and Tristan Honda and Liebeskind, {David S.} and Karen Furie",

year = "2022",

month = mar,

day = "1",

doi = "10.1161/STROKEAHA.121.037541",

language = "English (US)",

volume = "29",

pages = "728--738",

journal = "Stroke",

issn = "0039-2499",

publisher = "Lippincott Williams and Wilkins",

number = "2",

}

TY - JOUR

T1 - Direct Oral Anticoagulants Versus Warfarin in the Treatment of Cerebral Venous Thrombosis (ACTION-CVT)

T2 - A Multicenter International Study

AU - Yaghi, Shadi

AU - Shu, Liqi

AU - Bakradze, Ekaterina

AU - Salehi Omran, Setareh

AU - Giles, James A.

AU - Amar, Jordan Y.

AU - Henninger, Nils

AU - Elnazeir, Marwa

AU - Liberman, Ava L.

AU - Moncrieffe, Khadean

AU - Lu, Jenny

AU - Sharma, Richa

AU - Cheng, Yee

AU - Zubair, Adeel S.

AU - Simpkins, Alexis N.

AU - Li, Grace T.

AU - Kung, Justin Chi

AU - Perez, Dezaray

AU - Heldner, Mirjam

AU - Scutelnic, Adrian

AU - Seiffge, David

AU - Siepen, Bernhard

AU - Rothstein, Aaron

AU - Khazaal, Ossama

AU - Do, David

AU - Kasab, Sami Al

AU - Rahman, Line Abdul

AU - Mistry, Eva A.

AU - Kerrigan, Deborah

AU - Lafever, Hayden

AU - Nguyen, Thanh N.

AU - Klein, Piers

AU - Aparicio, Hugo

AU - Frontera, Jennifer

AU - Kuohn, Lindsey

AU - Agarwal, Shashank

AU - Stretz, Christoph

AU - Kala, Narendra

AU - El Jamal, Sleiman

AU - Chang, Alison

AU - Cutting, Shawna

AU - Xiao, Han

AU - De Havenon, Adam

AU - Muddasani, Varsha

AU - Wu, Teddy

AU - Wilson, Duncan

AU - Nouh, Amre

AU - Asad, Syed Daniyal

AU - Qureshi, Abid

AU - Moore, Justin

AU - Khatri, Pooja

AU - Aziz, Yasmin

AU - Casteigne, Bryce

AU - Khan, Muhib

AU - Cheng, Yao

AU - Mac Grory, Brian

AU - Weiss, Martin

AU - Ryan, Dylan

AU - Vedovati, Maria Cristina

AU - Paciaroni, Maurizio

AU - Siegler, James E.

AU - Kamen, Scott

AU - Yu, Siyuan

AU - Leon Guerrero, Christopher R.

AU - Atallah, Eugenie

AU - De Marchis, Gian Marco

AU - Brehm, Alex

AU - Dittrich, Tolga

AU - Psychogios, Marios

AU - Alvarado-Dyer, Ronald

AU - Kass-Hout, Tareq

AU - Prabhakaran, Shyam

AU - Honda, Tristan

AU - Liebeskind, David S.

AU - Furie, Karen

PY - 2022/3/1

Y1 - 2022/3/1

N2 - 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]; P=0.84), death (aHR, 0.78 [95% CI, 0.22-2.76]; P=0.70), and rate of partial/complete recanalization (aOR, 0.92 [95% CI, 0.48-1.73]; P=0.79), but a lower risk of major hemorrhage (aHR, 0.35 [95% CI, 0.15-0.82]; P=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.

AB - 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]; P=0.84), death (aHR, 0.78 [95% CI, 0.22-2.76]; P=0.70), and rate of partial/complete recanalization (aOR, 0.92 [95% CI, 0.48-1.73]; P=0.79), but a lower risk of major hemorrhage (aHR, 0.35 [95% CI, 0.15-0.82]; P=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.

KW - anticoagulants

KW - contraindications

KW - dabigatran

KW - hemorrhage

KW - venous thrombosis

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U2 - 10.1161/STROKEAHA.121.037541

DO - 10.1161/STROKEAHA.121.037541

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AN - SCOPUS:85125554126

SN - 0039-2499

VL - 29

SP - 728

EP - 738

JO - Stroke

JF - Stroke

IS - 2

ER -

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

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