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N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.

Oral rivaroxaban for symptomatic venous thromboembolism.

Collaborators (483)

Agnelli G, Berkowitz S, Bounameaux H, Büller H, Cohen A, Gallus A, Lensing A, Misselwitz F, Peters G, Prins M, Raskob G, Schellong S, Bauersachs R, van Bellen B, Boda Z, Borris L, Brenner B, Brighton T, Chlumský Y, Davidson B, Decousus H, Eriksson H, Jacobson B, Kakkar A, Kwong YL, Lee LH, Meijer K, van der Meer J, Minar E, Monreal M, Piovella F, Sandset PM, Smith M, Tomkowski W, Verhamme P, Wang Y, Wells P, Brandjes D, Mac Gillavry M, Otten HM, Prins M, Carlsson A, Laporte S, Schulman S, Muehlhofer E, Tewes M, Whatton J, Mueller K, Beckmann H, Pap AF, Spadari G, Peters-Wulf C, Kubitza D, Muck W, Coughlin P, Chong B, Carroll P, Connors G, Baker R, Gallus A, Gan E, Leyden M, Crispin P, Ward C, Bianchi A, Leahy M, Brighton T, Blombery P, Campbell P, Dean M, Jackson D, Denaro C, Hirschl M, Baghestanian M, Mathies R, Pilger E, Marschang P, Vossaert R, Hainaut P, Motte S, Verhaeghe R, Verhamme P, Vandekerkhof J, Vleeschauwer P, de Leersnyder J, Demelenne J, Buche M, Vermassen F, Sprynger M, van Bellen B, Moreira R, Costa J, Sacilotto R, Silvestre J, Yoshida W, Panico M, Wolosker N, Kovacs M, Wells P, Wong T, Selby R, Geerts W, Blondal J, Chen Z, Zhang J, Wang Y, Liu C, Dong Y, Guo W, Wu D, Ying K, Li X, Jin B, Xu J, Jing Z, Liu Z, Jing Z, Kovarova K, Spacek R, Podpera I, Patek F, Vitovec M, Chlumský J, Matoška P, Husted S, Tuxen C, Hildebrandt P, Nielsen H, Decousus H, Aquilanti S, Pernod G, Lacroix P, Schmidt J, Brisot D, Quere I, Mottier D, Stephan D, Achkar A, Boccalon H, Simoneau G, Lorenzini JL, Trinh-Duc A, Mahe I, Elias A, Emmerich J, Meneveau N, Roy PM, Vital-Durand D, Constans J, Le Jeunne C, Agraou B, Ferrari E, Meyer G, Potel G, Parent F, Sevestre MA, Franke D, Schellong S, Petermann W, Beyer-Westendorf J, Diehm C, Baron Von Bilderling P, Hoffmann U, Hasslacher C, Landgraf H, Horacek T, Bauersachs R, Lindhoff-Last E, Heckmann F, Mondorf W, Espinola-Klein C, Haering HU, Kieback A, Taute BM, Eifrig B, Potratz J, Herrmann T, Röcken M, Tse E, Kovács A, Sipos G, Farkas K, Gurzo M, Boda Z, Riba M, Landi A, Pécsvárady Z, Parakh R, Ramakrishna P, Sudhindran S, Kamerkar D, Sembiring R, Soeharti C, Tambunan K, Sumantri R, Zeltser D, Elias M, Hoffman R, Lishner M, Gavish D, Hussein O, Lugassy G, Varon D, Inbal A, Zisman D, Schliamser L, Haran M, Ghirarduzzi A, Barone M, Beltrametti C, Imberti D, Prandoni P, Porreca E, Di Nisio M, Martinelli I, Siragusa S, Ageno W, Ambrosio G, Palareti G, D'Angelo A, Quintavalla R, Cattaneo M, Park KH, Cho WH, Sathar J, Meier K, van der Meer J, van Marwijk-Kooy M, Beeker A, Komdeur R, Kamphuisen PW, Groot M, Ten Cate H, Ockelford P, Simpson D, Harper P, Royle G, Beasley R, Smith M, Quist-Paulsen P, Sandset PM, Ghanima W, Tveit A, Abola M, Roxas D, Chęciński P, Adamiec R, Kloczko J, Witkiewicz W, Tomkowski W, Wronski J, Musial J, Oszkinis G, Strzelczyk J, Szyber P, Jackowski M, Ng J, Tay C, Becker J, Isaacs R, Jacobson B, Adler D, Siebert R, van Zyl L, Wright N, van Marle J, Ellis G, Schmidt S, Villalta J, García-Bragado F, Sanchez J, Fontcuberta J, Eriksson H, Aagesen J, Jonson T, Själander A, Mazzolai L, Bounameaux H, Banyai M, Frank U, Reinhardt W, Dorffler-Melly J, Asmis L, Chiu KM, Tsai W, Yu TJ, Angchaisuksiri P, Rojnuckarin P, Hunt B, Nokes T, Cohen A, Sekhar M, Dexter J, Lyons R, Nadar V, Krell K, Rehm J, Rathbun S, Spyropoulos A, Moll S, Chen D, Banish D, Joseph S, Rodgers G, Stevens S, Wright P, Botnick W, Albrecht C, Jaffer A, Kennedy M, Rodriguez W, Coughlin P, Chong B, Leyden M, Connors G, Gan E, Jackson D, Gallus A, Baker R, Bianchi A, Campbell P, Carroll P, Denaro C, McRae S, Blombery P, Dean M, Ward C, Crispin P, Marschang P, Hirschl M, Mathies R, Baghestanian M, Kyrle PA, Forstner K, Pilger E, Verhaeghe R, Verhamme P, Vossaert R, Motte S, Vermassen F, Sprynger M, Soffiatti R, van Bellen B, Panico M, Sacilotto R, Moreira R, Silvestre J, Zhang J, Wang C, Li X, Liu C, Chen Z, Wang Y, Jing Z, Wu D, Spacek R, Kovarova K, Vitovec M, Matoška P, Povolny J, Chlumský J, Patek F, Nielsen HK, Husted S, Hildebrandt P, Decousus H, Schmidt J, Aquilanti S, Pernod G, Lorenzini JL, Achkar A, Brisot D, Mottier D, Trinh-Duc A, Lacroix P, Quere I, Parent F, Potel G, Stephan D, Wahl D, Mahe I, Roy PM, Sevestre MA, Petermann W, Diehm C, Franke D, Harenberg J, Baron Von Bilderling P, Hasslacher C, von Schwaiblmair W, Sipos G, Kovács A, Farkas K, Gurzo M, Pécsvárady Z, Boda Z, Riba M, Parakh R, Kamerkar D, Ramakrishna P, Sudhindran S, Sembiring RJ, Elias M, Hoffman R, Zeltser D, Gavish D, Lishner M, Lugassy G, Zisman D, D'Angelo, Porreca E, Baresne M, Beltrametti C, Prandoni P, Cattaneo M, Di Minno G, Quintavalla R, Ambrosio G, Imberti D, Palareti G, Siragusa S, Sathar J, van der Meer J, Kamphuisen PW, van Marwijk Kooy M, Beeker A, Mol J, Simpson D, Ockelford P, Harper P, Smith M, Beasley R, Sandset PM, Ghanima W, Tveit A, Abola MT, Roxas DJ, Tomkowski W, Strzelczyk K, Adamiec R, Lewczuk J, Kloczko J, Musial J, Szyber P, Ng HJ, Tay JC, Jacobson B, Becker JH, Isaacs R, Siebert RS, Adler D, Ellis G, Wright N, van Marle J, van Zyl L, Redondo M, Villalta J, Fontcuberta J, de Diego I, García-Bragado F, Grau E, Eriksson H, Lapidus L, Jonson T, Själander A, Aagesen J, Wallen T, Bounameaux H, Banyai M, Angchaisuksiri P, Rojnuckarin P, Luckit J, Cohen A, Sekhar M, Lyons R, Krell K, Rathbun S, Spyropoulos A, Wright P, Joseph S, Kennedy M, Moll S, Cymet T.

Abstract

BACKGROUND:

Rivaroxaban, an oral factor Xa inhibitor, may provide a simple, fixed-dose regimen for treating acute deep-vein thrombosis (DVT) and for continued treatment, without the need for laboratory monitoring.

METHODS:

We conducted an open-label, randomized, event-driven, noninferiority study that compared oral rivaroxaban alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with subcutaneous enoxaparin followed by a vitamin K antagonist (either warfarin or acenocoumarol) for 3, 6, or 12 months in patients with acute, symptomatic DVT. In parallel, we carried out a double-blind, randomized, event-driven superiority study that compared rivaroxaban alone (20 mg once daily) with placebo for an additional 6 or 12 months in patients who had completed 6 to 12 months of treatment for venous thromboembolism. The primary efficacy outcome for both studies was recurrent venous thromboembolism. The principal safety outcome was major bleeding or clinically relevant nonmajor bleeding in the initial-treatment study and major bleeding in the continued-treatment study.

RESULTS:

The study of rivaroxaban for acute DVT included 3449 patients: 1731 given rivaroxaban and 1718 given enoxaparin plus a vitamin K antagonist. Rivaroxaban had noninferior efficacy with respect to the primary outcome (36 events [2.1%], vs. 51 events with enoxaparin-vitamin K antagonist [3.0%]; hazard ratio, 0.68; 95% confidence interval [CI], 0.44 to 1.04; P<0.001). The principal safety outcome occurred in 8.1% of the patients in each group. In the continued-treatment study, which included 602 patients in the rivaroxaban group and 594 in the placebo group, rivaroxaban had superior efficacy (8 events [1.3%], vs. 42 with placebo [7.1%]; hazard ratio, 0.18; 95% CI, 0.09 to 0.39; P<0.001). Four patients in the rivaroxaban group had nonfatal major bleeding (0.7%), versus none in the placebo group (P=0.11).

CONCLUSIONS:

Rivaroxaban offers a simple, single-drug approach to the short-term and continued treatment of venous thrombosis that may improve the benefit-to-risk profile of anticoagulation. (Funded by Bayer Schering Pharma and Ortho-McNeil; ClinicalTrials.gov numbers, NCT00440193 and NCT00439725.).

Comment in

PMID:
21128814
[PubMed - indexed for MEDLINE]
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