Titre
Rivaroxaban or Aspirin for Extended Treatment of Venous Thromboembolism.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Weitz, J.I.
Auteure/Auteur
Lensing, AWA
Auteure/Auteur
Prins, M.H.
Auteure/Auteur
Bauersachs, R.
Auteure/Auteur
Beyer-Westendorf, J.
Auteure/Auteur
Bounameaux, H.
Auteure/Auteur
Brighton, T.A.
Auteure/Auteur
Cohen, A.T.
Auteure/Auteur
Davidson, B.L.
Auteure/Auteur
Decousus, H.
Auteure/Auteur
Freitas, MCS
Auteure/Auteur
Holberg, G.
Auteure/Auteur
Kakkar, A.K.
Auteure/Auteur
Haskell, L.
Auteure/Auteur
van Bellen, B.
Auteure/Auteur
Pap, A.F.
Auteure/Auteur
Berkowitz, S.D.
Auteure/Auteur
Verhamme, P.
Auteure/Auteur
Wells, P.S.
Auteure/Auteur
Prandoni, P.
Auteure/Auteur
Contributrices/contributeurs
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.
GarcÃa-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.
Groupes de travail
EINSTEIN CHOICE Investigators
Liens vers les personnes
Liens vers les unités
ISSN
1533-4406
Statut éditorial
Publié
Date de publication
2017-03-30
Volume
376
Numéro
13
Première page
1211
Dernière page/numéro d’article
1222
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Comment
Publication Status: ppublish
Publication Status: ppublish
Résumé
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 .).
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 .).
Sujets
PID Serval
serval:BIB_7C01478D4BFC
PMID
Date de création
2018-10-12T11:40:26.079Z
Date de création dans IRIS
2025-05-20T21:01:26Z
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nejmoa1700518.pdf
Version du manuscrit
published
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289.06 KB
Format
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PID Serval
serval:BIB_7C01478D4BFC.P001
URN
urn:nbn:ch:serval-BIB_7C01478D4BFC0
Somme de contrôle
(MD5):dd50c8bdaf6dad241e3f2ddad1d7db92