Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.

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Version: Final published version
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Serval ID
serval:BIB_7C01478D4BFC
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.
Journal
The New England journal of medicine
Author(s)
Weitz J.I., Lensing AWA, Prins M.H., Bauersachs R., Beyer-Westendorf J., Bounameaux H., Brighton T.A., Cohen A.T., Davidson B.L., Decousus H., Freitas MCS, Holberg G., Kakkar A.K., Haskell L., van Bellen B., Pap A.F., Berkowitz S.D., Verhamme P., Wells P.S., Prandoni P.
Working group(s)
EINSTEIN CHOICE Investigators
Contributor(s)
Bianchi A., Brighton T., Carroll P., Chong B., Chunilal S., Coughlin P., Curnow J., Jackson D., Tran H., Ward C., Brodmann M., Kyrle P., Marschang P., Petkov V., Hainaut P., Jordens P., Vandekerkhof J., Verhamme P., Wautrecht J-C, Annichino-Bizzacchi J., van Bellen B., Correa J., Cukier A., Freire A., Pereira A., Porto C., Sacilotto R., Vasconcelos Costa A., Della Siega A., Dolan S., Le Gal G., Gross P., Kahn S., Kassis J., Kovacs M., Pesant Y., Ritchie B., Schulman S., Shivakumar S., Solymoss S., Chang S., Chen R., Chen Z., Chen H., Dai X., Fang B., Fu W., Gao X., Huang J., Lai Y., Li L., Li X., Li Y., Liu J., Liu S., Ma W., Ni S., Qin Z., Shi G., Tian H., Wang S., Wang L., Xiao W., Ying K., Yu G., Yuan Y., Zhang J., Zhang J., Zhang X., Zhang L., Zhu L., Chlumský J., Chochola J., Dunaj M., Kovarova K., Lang P., Matoška P., Podpera I., Spacek R., Stehlikova O., Brønnum-Schou J., Egstrup K., Gislason G., Jeppesen J., May O., Nielsen H., Wiggers H., Achkar A., Aquilanti S., Benhamou Y., Brisot D., Bura-Riviere A., Castella N., Elias A., Falvo N., Ferrari E., Lacroix P., Mahe I., Meneveau N., Messas E., Mismetti P., Montaclair K., Mottier D., Moumneh T., Paleiron N., Parent F., Pernod G., Sanchez O., Schmidt J., Simoneau G., Stephan D., Amann B., Bauersachs R., Beyer-Westendorf J., Blessing E., Czihal M., Espinola-Klein C., Kahrmann G., Licka M., Neumeister A., Schellong S., Boda Z., Farkas K., Gurzo M., Katona A., Riba M., Sipos G., Tóth K., Braester A., Elias M., Gafter-Gvili A., Gavish D., Hussein O., Lishner M., Schiff E., Spectre G., Tzoran-Rozenthal I., Zimlichman R., Ageno W., Agnelli G., Bova C., Garbelotto R., Ghirarduzzi A., Imberti D., Pesavento R., Porreca E., Visonà A., Flota Cervera L., Llamas Esperón G., Rodriguez-Gonzalez D., Solis Morales L., Boersma W., ten Cate H., Erdkamp F., Grifioen-Keijzer A., Marwijk Kooy M., Meijer K., Middeldorp S., Swart-Heikens J., Ten Wolde M., Westerweel P., Braithwaite I., Harper P., Merriman E., Ockelford P., Royle G., Smith M., Ghanima W., Sandset P.M., Abola M., Chęciński P., Grzelakowski P., Lewczuk J., Sobkowicz B., Tomkowski W., Abramov I., Chechulov P., Karpenko A., Katelnitskiy I., Kazakov A., Makarova O., Panchenko E., Sergeeva E., Subbotin Y., Suchkov I., Zeltser M., Adler D., Breedt J., Fourie N., Isaacs R., Jacobson B., Siebert H., van Zyl L., Choi J-H, Kang S-M, Kim K-H, Kim H-S, Kim D-I, Min S-K, Park K.H., García-Bragado Dalmau F., Gómez Cerezo J., Mirete JCF, Riera A., Del Toro J., Eriksson H., Torstensson I., Banyai M., Baumgartner I., Mazzolai L., Periard D., Righini M., Staub D., Chiang C-E, Chiu K-M, Pai P-Y, Angchaisuksiri P., Chansung K., Öngen G., Tuncay E., Alikhan R., Chetter I., Kesteven P., Nokes T., Bauer K., Comerota A., Elias D., Garcia D., Gibson K., Ginsberg D., Jenkins J., Kingsley E., Lambert R., Lyons R., Pullman J., Shah V., Smith S.W., Stein R., Tapson V., Walsh J., Wang T-F, Do Loi D., Do Quang H., Pham N.
ISSN
1533-4406 (Electronic)
ISSN-L
0028-4793
Publication state
Published
Issued date
30/03/2017
Peer-reviewed
Oui
Volume
376
Number
13
Pages
1211-1222
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Comment
Publication Status: ppublish
Abstract
Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin.
In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding.
A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups.
Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates. (Funded by Bayer Pharmaceuticals; EINSTEIN CHOICE ClinicalTrials.gov number, NCT02064439 .).
Keywords
Adult, Aged, Aspirin/administration & dosage, Aspirin/adverse effects, Double-Blind Method, Drug Administration Schedule, Factor Xa Inhibitors/administration & dosage, Factor Xa Inhibitors/adverse effects, Female, Hemorrhage/chemically induced, Humans, Intention to Treat Analysis, Kaplan-Meier Estimate, Male, Middle Aged, Platelet Aggregation Inhibitors/administration & dosage, Platelet Aggregation Inhibitors/adverse effects, Rivaroxaban/administration & dosage, Rivaroxaban/adverse effects, Secondary Prevention, Venous Thromboembolism/mortality, Venous Thromboembolism/prevention & control
Pubmed
Web of science
Create date
12/10/2018 12:40
Last modification date
08/05/2020 13:39
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