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Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.

Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.

Collaborators (232)

Schulman S, Eriksson H, Goldhaber S, Kakkar A, Kearon C, Mismetti P, Schellong S, Bergqvist D, Tijssen J, Prins M, Robben S, Büller H, Otten HM, Brandjes D, Prins M, Büller H, Otten HM, Brandjes D, Prins M, Peters R, Mac Gillavry MR, Gan E, Salem H, Baker R, Blomberry P, Curnow J, Annichino-Bizzacch JM, Brandao Panico MD, Timi Ribas JR, Fernandes Manenti ER, Miranda F Jr, Moraes J Jr, Raev D, Mollov M, Peneva M, Milanov S, Anderson D, Crowther M, Dolan S, Eikelboom J, Game M, Kahn S, Kassis J, Kearon C, Ritchie B, Solymoss S, Rodger M, Yeo E, Milot A, Klinke P, Chen W, Zhihong L, Chunxue B, Jinming L, Jiwei Z, Jie C, Jina K, Yuqi W, Zhongqi Y, Hua W, Kejing Y, Bonan L, Yadong Y, Changwei L, Jin Z, Yongcheng D, Spinar J, Maly R, Cizek V, Bercikova J, Cervinka P, Lang P, Jirka V, Oral I, Reichert P, Kotik L, Pojsl S, Klimovic T, Husted S, Nielsen H, Friis E, Skødebjerg Kristensen K, Mottier D, Mismetti P, El Kouri D, Bleher Y, Leroux L, Boda Z, Sereg M, Riba M, Hiremath JS, Kareem S, Banker DN, Gadkari M, Parakh R, Suresh KR, Natarajan S, Jain A, Aggarwal PK, Patil CB, Durairaj N, Seshadri R, Thakore VM, Rai KM, Efrati S, Elias M, Gavish D, Grossman M, Lishner M, Lahavr M, Lugassy G, Nseir W, Zeltser D, Brenner B, Yeganeh S, Zanatta N, Pizzini AM, Di Salvo M, Novo S, Arosio E, Campanini M, Castellani S, Oh DY, Cho DK, Kim DI, Kwon TW, Yoon SS, Kim MH, Kwon SY, Cheong JW, Lee TS, Shokri AA, Looi TS, Chon Y, Chunn KY, Salleh R, Fijnheer R, Veth G, Dees A, Pruijt H, Lieverse AG, Jie GK, van Marwijk-Kooij M, Simsek S, Hanna M, Jackson S, Ockelford P, Smith M, Sandset PM, Waage A, Fernandez L, Ma A, De Guia T, Ong-Garcia H, Lach L, Zawilska K, Gluszek S, Czarnobilski K, Gaciong Z, Chernyatina M, Tchumakov A, Staroverov I, Belentsov S, Katelnitsky I, Khamitov A, Zaporozhsky A, Degterev M, Khitaryan A, Heng LL, Robless PA, Kenny SY, Poliacik P, Duris T, Szentivanyi M, Zubek V, Adler D, Smith C, Roux D, Van Rensburg J, Miller D, Ismail S, Roodt A, Vermooten IH, Villalta J, Nieto JA, Trujillo J, del Toro J, García Fuster MJ, Giménez A, Lozano P, Holmström M, Eriksson H, Edmark M, Carlsson A, Torstensson I, Huang CH, Shyu KG, Chiang CE, Shen MC, Tsai CS, Wang SS, Sirijerachai C, Saetang S, Kanitsap N, Polprasert C, Mutirangura P, Boonbaichaiyapruck S, Leelasiri A, Kurtoglu M, Eren E, Bengisun U, Sakinci U, Karahan S, Islamoglu F, Kurt N, Aygun E, Skupyy O, Keeling D, Kesteven P, Cohen A, Maclean R, Thomas W, Masson JA, Bolster E, Beard T, Gasparis A, LaPerna LM, Gibson K, Curtis B, Chu CO, Bass P 3rd, Lavende R.

Author information

1
Department of Medicine, McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada (S. Schulman, C.K.); Department of Hematology, Karolinska University Hospital, Stockholm, Sweden (S.S.); Thrombosis Research Institute and University College London, London, UK (A.K.K.); Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.Z.G.); Medical Division 2, Municipal Hospital Friedrichstadt, Dresden, Germany (S. Schellong); Department of Medicine, Sahlgrenska University Hospital-Östra, Gothenburg, Sweden (H.E.); Department of Vascular Pathology, Bellevue Hospital, Saint Etienne, France (P.M.); Clinical Research, Boehringer Ingelheim, Copenhagen, Denmark (A.V.C.); Boehringer Ingelheim, Ridgefield, CT (J.F.); Boehringer Ingelheim, Reims, France (F.L.M.); and Boehringer Ingelheim, Biberach and der Riss, BDM, Germany (N.P.).

Abstract

BACKGROUND:

Dabigatran and warfarin have been compared for the treatment of acute venous thromboembolism (VTE) in a previous trial. We undertook this study to extend those findings.

METHODS AND RESULTS:

In a randomized, double-blind, double-dummy trial of 2589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5 to 11 days, we compared dabigatran 150 mg twice daily with warfarin. The primary outcome, recurrent symptomatic, objectively confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients (2.3%) compared with 28 of the 1289 warfarin patients (2.2%; hazard ratio, 1.08; 95% confidence interval [CI], 0.64-1.80; absolute risk difference, 0.2%; 95% CI, -1.0 to 1.3; P<0.001 for the prespecified noninferiority margin for both criteria). The safety end point, major bleeding, occurred in 15 patients receiving dabigatran (1.2%) and in 22 receiving warfarin (1.7%; hazard ratio, 0.69; 95% CI, 0.36-1.32). Any bleeding occurred in 200 dabigatran (15.6%) and 285 warfarin (22.1%; hazard ratio, 0.67; 95% CI, 0.56-0.81) patients. Deaths, adverse events, and acute coronary syndromes were similar in both groups. Pooled analysis of this study RE-COVER II and the RE-COVER trial gave hazard ratios for recurrent VTE of 1.09 (95% CI, 0.76-1.57), for major bleeding of 0.73 (95% CI, 0.48-1.11), and for any bleeding of 0.70 (95% CI, 0.61-0.79).

CONCLUSION:

Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE.

CLINICAL TRIAL REGISTRATION URL:

www.clinicaltrials.gov. Unique identifiers: NCT00680186 and NCT00291330.

KEYWORDS:

antagonists & inhibitors; hemorrhage; recurrence; thrombin; venous thromboembolism; warfarin

[Indexed for MEDLINE]

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