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N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.

Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.

Collaborators (451)

Schulman S, Eriksson H, Goldhaber S, Kakkar A, Kearon C, Mismetti P, Schellong S, Minar E, Bergqvist D, Tijssen J, Prins M, Büller H, Otten J, Prins M, Mac Gillavry M, Brandjes D, Otten H, Prins M, Peters R, Mac Gillavry M, Büller H, Pol S, Burroughs A, Gilmore I, Bluguermann J, Bustos B, Carlevaro O, Cartasegna L, Cuello J, Gabito A, Gitelman P, Gutierrez Carrillo N, Hrabar A, Mackinon I, Santos D, Schygiel P, Sosa Liprandi M, Baker R, Blombery P, Gallus A, Gan E, McCann A, Salem H, Koppensteiner R, Kyrle P, Pilger E, Sturm W, Hainaut P, Verhamme P, Wautrecht JC, Zicot M, Bizzachi J, Joyce M, Araújo G, de Araújo Filho J, Panico M, Pereira A, Rocha Moreira R, Timi J, Yamashita E, Anastasov V, Georgiev G, Guirov K, Lozev I, Milanov S, Peneva M, Petrov V, Yordanov Y, Anderson D, Crowther M, Dolan S, Eikelboom J, Game M, Kahn S, Kassis J, Kearon C, Klinke P, Ritchie B, Rodger M, Solymoss S, Spencer F, Yeo E, Bai C, Liu C, Liu C, Liu J, Shen H, Wan H, Wang C, Wang Y, Wen F, Ying K, Yuan Y, Zhang J, Zhang L, Zheng Q, Zhong N, Bercikova J, Cervinka P, Cizek V, Jirka V, Lang P, Maly R, Oral I, Prochazka P, Spinar J, Brønnum-Schou J, Friis E, Jensen S, Nielsen H, Skødebjerg Kristensen K, Wiemann O, Husted S, Kuusisto A, Lassila R, Melin J, Nikkilä M, Nousiainen T, Bost V, Buchmuller A, Guillot K, Lecomte F, Mottier D, Wahl D, Beyer-Westendorf J, Dormann A, Harenberg J, Hoffmann U, Hoffmann U, Maier M, Mietaschk A, Salbach P, Schellong S, Cohen A, Keeling D, Kesteven P, Maclean MR, Shah P, Katsenis K, Klonaris C, Liappis C, Mihailidis D, Acsady G, Boda Z, Farkas K, Jakucs J, Kollar L, Matyas L, Muranyi A, Riba M, Sereg M, Banker D, Durairaj N, Gadkari M, Grant P, Hiremath J, Kareem S, Mahajan R, Naik A, Parakh R, Rai K, Santhosh M, Sekar N, Srinivas A, Suresh K, Vijayaraghavan G, Brenner B, Efrati S, Mazen E, Gavish D, Grossman E, Lahav M, Lishner M, Lugassy G, Zeltser D, Barillari G, D' Angelo A, Palareti G, Santonasto M, Schenone A, Silingardi M, Testa S, Aldrett Lee E, Fontes Andrade J, Jaurrieta Valles J, Montaño-González E, Sánchez-Escalante LR, Dees A, Hamulyak K, Jie A, Kamphuisen P, Leebeek F, Nurmohamed M, Pruijt J, Wittebol S, Hanna M, Jackson S, Ockelford P, Smith M, Njaastad A, Sandseth P, Tveit A, Waage A, Czarnobilski K, Gaciong Z, Gluszek S, Krolczyk J, Zawilska K, Barata J, Capitao M, e Fernandes F, Martinez J, Providência L, Sarmento P, Belentsov S, Chernyatina M, Chernyavsky A, Degterev M, Fokin A, Gubenko A, Guz V, Katelnitsky I, Katelnitsky I, Khamitov A, Khitaryan A, Khubulava G, Koulikovsky V, Nelaev V, Shkurin V, Smirnov G, Sokurenko G, Soroka V, Staroverov I, Zaporozhsky S, Duris T, Poliacik P, Spisak V, Szentivanyi M, Zubek V, Adler D, Le Roux D, Routier R, Siebert R, Sloane B, Smith C, del Toro J, García-Fuster M, Marco P, Mateo J, Monreal M, Nieto J J, Sedano C, Trujillo J, Villalta J, Aagesen J, Carlsson A, Eriksson H, Lärfars G, Lindmarker P, Säfwenberg U, Själander A, Aslim E, Bengisun U, Calkavur T, Eren E, Karahan S, Karatepe O, Kurtoglu M, Sakinci U, Gubka O, Karpovych D, Mishalov V, Skupyy O, Bartkowiak A Jr, Bolster E, Burnett B, Comerota A, Fulco F, Gleeson J, Goldhaber S, Gossage J, Kaatz S, Kuehl S, Lahiri B, Masson J, Moll S, Nathanson A, Paulson R, Powell R, Seibert A, Vrooman P, Eriksson H, Sandgren G, Wallin J, Kälebo P, Angerås U, Falk A, Eriksson B, Dellborg M, Eriksson P, Johansson P, Hansson PO, Pol S, Burroughs A, Gilmore I, Gan E, Nicol A, Jeffries B, Benson M, Kyrle PA, Hirschl M, Böhler K, Pilger E, Sturm W, Verhamme P, de Vleeschauwer P, Haerens M, Duchateau J, Verstraeten P, Dolan S, Eikelboom J, Ritchie B, Milot A, Kotik L, Roztocil K, Joerg I, Holy M, Cernosek B, Kasalova Z, Mandakova E, Povolny J, Matoska P, Hulinsky V, Cizek V, Podoubsky R, Votocek S, Zarubova D, Ellervee T, Lind J, Sukles K, Hoffmann U, Mietaschk A, Maier M, Salbach P, Uebel P, Bauersachs R, Kemkes-Matthes B, Schellong S, Beyer J, Siragusa S, Barillari G, Bova C, Cortellaro M, Falanga A, Palla A, Pini M, Poggio R, Porro F, Prisco D, Tiraferri E, Villalta S, Visona A, Zanatta N, Mazzucconi MG, Porreca E, Cattaneo M, Di Minno G, Oh D, Kim CS, Kwon TW, Lee TS, Park JS, Hong YS, Yoon SS, Kim YK, Laucevicius A, Miliauskas S, Novikovs N, Zvirgzdins V, Meijer K, Nijziel MR, van Guldener C, van Essen GG, Ouwehand ME, Jie KS, Swart-Heikens J, Viergever PP, Dullemond AC, Smith M, Tomkowski W, Torbicki A, Psuja P, Staszkiewicz W, Szopinski P, Pruszczyk P, Ciostek P, Windyga J, Stepien J, Chernyatina M, Smirnov G, Staroverov I, Belentsov S, Khamitov AA, Ng HJ, Eriksson H, Elf J, Engquist L, Sharo S, Holmström M, Lapidus L, Cederin B, Brack T, Binkert M, Canova C, Franzeck U, Allmann JK, Zehnder T, Jeanneret C, Jäger K, Erni D, Banyai M, Rödel C, Engelbrecht J, Bruning A, van Rensburg H, Vermooten IH, Norasetthada L, Thungthong P, Angchaisuksiri P, Numbenjapon T, Cook R, Deck K, Evans B, Hearne S, Kaelin T, Kuno R, Pendelton R, Speer J, Yood R, Kahn R, Sheehan K, Feldman G, Chen YC, Fanning J, Hartley P, Kulback S, McIvor ME, LaPerna L, Gibson K, Vaid BR, Changlani M.

Abstract

BACKGROUND:

Dabigatran, which is administered in a fixed dose and does not require laboratory monitoring, may be suitable for extended treatment of venous thromboembolism.

METHODS:

In two double-blind, randomized trials, we compared dabigatran at a dose of 150 mg twice daily with warfarin (active-control study) or with placebo (placebo-control study) in patients with venous thromboembolism who had completed at least 3 initial months of therapy.

RESULTS:

In the active-control study, recurrent venous thromboembolism occurred in 26 of 1430 patients in the dabigatran group (1.8%) and 18 of 1426 patients in the warfarin group (1.3%) (hazard ratio with dabigatran, 1.44; 95% confidence interval [CI], 0.78 to 2.64; P=0.01 for noninferiority). Major bleeding occurred in 13 patients in the dabigatran group (0.9%) and 25 patients in the warfarin group (1.8%) (hazard ratio, 0.52; 95% CI, 0.27 to 1.02). Major or clinically relevant bleeding was less frequent with dabigatran (hazard ratio, 0.54; 95% CI, 0.41 to 0.71). Acute coronary syndromes occurred in 13 patients in the dabigatran group (0.9%) and 3 patients in the warfarin group (0.2%) (P=0.02). In the placebo-control study, recurrent venous thromboembolism occurred in 3 of 681 patients in the dabigatran group (0.4%) and 37 of 662 patients in the placebo group (5.6%) (hazard ratio, 0.08; 95% CI, 0.02 to 0.25; P<0.001). Major bleeding occurred in 2 patients in the dabigatran group (0.3%) and 0 patients in the placebo group. Major or clinically relevant bleeding occurred in 36 patients in the dabigatran group (5.3%) and 12 patients in the placebo group (1.8%) (hazard ratio, 2.92; 95% CI, 1.52 to 5.60). Acute coronary syndromes occurred in 1 patient each in the dabigatran and placebo groups.

CONCLUSIONS:

Dabigatran was effective in the extended treatment of venous thromboembolism and carried a lower risk of major or clinically relevant bleeding than warfarin but a higher risk than placebo. (Funded by Boehringer Ingelheim; RE-MEDY and RE-SONATE ClinicalTrials.gov numbers, NCT00329238 and NCT00558259, respectively.).

PMID:
23425163
[PubMed - indexed for MEDLINE]
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