Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism A Randomized Trial

被引：110

作者：

Planquette, Benjamin ^{[1
,2
,7
]}

Bertoletti, Laurent ^{[7
,8
,9
,11
]}

Charles-Nelson, Anais ^{[3
]}

Laporte, Silvy ^{[7
,10
,11
]}

Grange, Claire ^{[7
,12
]}

Mahe, Isabelle ^{[2
,7
,13
]}

Pernod, Gilles ^{[7
,14
]}

Elias, Antoine ^{[7
,15
]}

Couturaud, Francis ^{[7
,16
]}

Falvo, Nicolas ^{[7
,17
,18
]}

Sevestre, Marie Antoinette ^{[7
,19
]}

Ray, Valerie ^{[7
,20
]}

Burnod, Alexis ^{[4
,5
,7
]}

Brebion, Nicolas ^{[7
]}

Roy, Pierre-Marie ^{[7
,22
,23
]}

Timar-David, Miruna ^{[21
]}

Aquilanti, Sandro ^{[7
,24
,25
]}

Constans, Joel ^{[7
,26
]}

Bura-Riviere, Alessandra ^{[7
,27
,28
,29
]}

Brisot, Dominique ^{[7
,30
]}

Chatellier, Gilles ^{[3
]}

Sanchez, Olivier ^{[1
,2
,7
]}

Meyer, Guy ^{[1
,2
,7
]}

Girard, Philippe ^{[6
,7
]}

Mismetti, Patrick ^{[7
,8
]}

机构：

[1] Univ Paris, INSERM, UMR S1140, Serv Pneumol & Soins Intensifs, Paris, France

[2] Univ Paris, Hop Europeen Georges Pompidou, AP HP, INSERM,UMR S1140, Paris, France

[3] Innovat Therapeut Hemostase Fdn Alain Carpentier, Lab Chirurg Expt, Unite Rech Clin, Paris, France

[4] PSL Res Univ, CIC EC1418, Hop Europeen Georges Pompidou, Dept Pneumol, Paris, France

[5] PSL Res Univ, Dept Soins Support, Dept Pneumol, Paris, France

[6] PSL Res Univ, Dept Soins Support, Inst Curie, Paris, France

[7] Inst Mutualiste Montsouris, CRIN INNOVTE Network, Paris, France

[8] Univ Paris, Serv Med Vasc & Therapeut, Paris, France

[9] INSERM, Paris, France

[10] CIC 1408, Unite Rech Clin, Innovat, Pharmacol, Paris, France

[11] CHU St Etienne, Hop Nord, SAINBIOSE U1059, St Etienne, France

[12] Univ Jean Monnet, Serv Med Interne, INSERM, St Etienne, France

[13] Univ Paris, CHU Lyon, Pierre Benite, France

[14] Hop Louis Mourier, AP HP, Serv Med Vasc, Colombes, France

[15] Univ Grenoble Alpes, Med Vasc, Grenoble, France

[16] Hop St Musse, CH Toulon Seyne Sur Mer, Pole Cardiol Vasc, Dept Med Interne & Pneu Mol, Toulon, France

[17] Univ Bretagne Occidentate, CHU Brest, Brest, France

[18] Serv Med Interne, EA 3878, CIC INSERM 1412, Brest, France

[19] CHU Dijon, Serv Med Vasc, Dijon, France

[20] CHU Amiens, Serv Med Polyvalente, Amiens, France

[21] Serv Oncol Medicate, Paris, France

[22] CHU Nimes, Serv Med Vasc, Nimes, France

[23] CHD Vendee, Dept Urgences, La Roche Sur Yon, France

[24] Univ Angers, CHU Angers, Angers, France

[25] Univ Angers, Inst Mitovasc UMR CNRS INSERM 1083 6015, Hop Prive Arms Bonnettes, Angers, France

[26] Serv Med Interne & Vasc, Arras, France

[27] CHU Bordeaux, Serv Med Vasc, Bordeaux, France

[28] CHU Toulouse, Stromalab, Toulouse, France

[29] CNRS, UMR 5273, UPS EFS INSERM U1031, Toulouse, France

[30] CHU Montpellier, Serv Med Interne & Vasc, Montpellier, France

来源：

CHEST | 2022年 / 161卷 / 03期

关键词：

cancer; direct oral anticoagulants; low-molecular-weight heparin; pulmonary embolism; randomized controlled trial; VTE; VENOUS THROMBOEMBOLISM; ORAL RIVAROXABAN;

D O I：

10.1016/j.chest.2021.09.037

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

BACKGROUND: Direct oral anticoagulants (DOACs) are an alternative to low-molecularweight heparin for treating cancer-associated VTE. RESEARCH QUESTION: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE? STUDY DESIGN AND METHODS: In a randomized open-label noninferiority trial, patients with active cancer who had proximal DVT, pulmonary embolism (PE), or both were assigned randomly to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months. RESULTS: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean agewas 69.4 years, and 115 patients (76.2%) hadmetastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (both the intention-to-treat and per-protocol populations: cumulative incidence, 6.4% vs 10.1%; subdistribution hazard ratio [SHR], 0.75; 95% CI, 0.21-2.66). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 1.4% vs 3.7%; SHR, 0.36; 95% CI, 0.04-3.43). Major or clinically relevant nonmajor bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence, 12.2% vs 9.8%; SHR, 1.27; 95% CI, 0.49-3.26). Overall, 19 patients (25.7%) and 20 patients (23.8%) died in the rivaroxaban and dalteparin groups, respectively (hazard ratio, 1.05; 95% CI, 0.56-1.97). INTERPRETATION: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for noninferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided.

引用

页码：781 / 790

页数：10

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