Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism
Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE. Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE? In a randomized open-label noninferiority trial, patients with active cancer who...
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| Veröffentlicht in: | Chest 2022-03, Vol.161 (3), p.781-790 |
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| creator | Planquette, Benjamin Bertoletti, Laurent Charles-Nelson, Anaïs Laporte, Silvy Grange, Claire Mahé, Isabelle Pernod, Gilles Elias, Antoine Couturaud, Francis Falvo, Nicolas Sevestre, Marie Antoinette Ray, Valérie Burnod, Alexis Brebion, Nicolas Roy, Pierre-Marie Timar-David, Miruna Aquilanti, Sandro Constans, Joel Bura-Rivière, Alessandra Brisot, Dominique Chatellier, Gilles Sanchez, Olivier Meyer, Guy Girard, Philippe Mismetti, Patrick Meyer, Guy Mismetti, Patrick Chatellier, Gilles Laporte, Silvy Decousus, Hervé Mahé, Isabelle Falvo, Nicolas Delluc, Aurélien Bertoletti, Laurent Laneau, Christine Dinut, Aurelia Aegerter, Philippe Emmerich, Joseph Girard, Philippe Messas, Emmanuel Revel, Marie-Pierre Charles-Nelson, Anaïs Acassat, Sandrine Grange, Claire Planquette, Benjamin Sanchez, Olivier Plaisance, Ludovic Poénou, Géraldine Pernod, Gilles Imbert, Bernard Zenati, Nora Couturaud, Francis Le Moigne, Emmanuelle Le Mao, Raphael Hoffmann, Clément Elias, Antoine Elias, Marie Loffroy, Romaric Jandot, Maud Sevestre, Marie-Antoinette Modéliar Rémond, Santhi Samy Ray, Valérie Burnod, Alexis Roy, Pierre-Marie Moumneh, Thomas Henni, Samir Brebion, Nicolas Timor-David, Miruna Constans, Joël Boulon, Carine Aquilanti, Sandro Brisot, Dominique Bura-Rivière, Alessandra |
| description | Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE.
Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?
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.
Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic 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).
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.
ClinicalTrials.gov; No.: NCT02746185; URL: www.clinicaltrials.gov
[Display omitted] |
| doi_str_mv | 10.1016/j.chest.2021.09.037 |
| format | Article |
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Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?
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.
Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic 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).
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.
ClinicalTrials.gov; No.: NCT02746185; URL: www.clinicaltrials.gov
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0000-0001-6197-8668 ; 0000-0001-7202-6910 ; 0000-0001-6437-7059 ; 0000-0003-1511-0555 ; 0000-0001-8020-9215 ; 0000-0003-1633-8391 ; 0000-0003-1760-7880 ; 0000-0002-1779-6936 ; 0000-0001-8213-7817 ; 0000-0002-3862-7680 ; 0000-0003-0227-1245 ; 0000-0002-1855-8032</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://hal.science/hal-03617627$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Planquette, Benjamin</creatorcontrib><creatorcontrib>Bertoletti, Laurent</creatorcontrib><creatorcontrib>Charles-Nelson, Anaïs</creatorcontrib><creatorcontrib>Laporte, Silvy</creatorcontrib><creatorcontrib>Grange, Claire</creatorcontrib><creatorcontrib>Mahé, Isabelle</creatorcontrib><creatorcontrib>Pernod, Gilles</creatorcontrib><creatorcontrib>Elias, Antoine</creatorcontrib><creatorcontrib>Couturaud, Francis</creatorcontrib><creatorcontrib>Falvo, Nicolas</creatorcontrib><creatorcontrib>Sevestre, Marie Antoinette</creatorcontrib><creatorcontrib>Ray, Valérie</creatorcontrib><creatorcontrib>Burnod, Alexis</creatorcontrib><creatorcontrib>Brebion, Nicolas</creatorcontrib><creatorcontrib>Roy, Pierre-Marie</creatorcontrib><creatorcontrib>Timar-David, Miruna</creatorcontrib><creatorcontrib>Aquilanti, Sandro</creatorcontrib><creatorcontrib>Constans, Joel</creatorcontrib><creatorcontrib>Bura-Rivière, Alessandra</creatorcontrib><creatorcontrib>Brisot, Dominique</creatorcontrib><creatorcontrib>Chatellier, Gilles</creatorcontrib><creatorcontrib>Sanchez, Olivier</creatorcontrib><creatorcontrib>Meyer, Guy</creatorcontrib><creatorcontrib>Girard, Philippe</creatorcontrib><creatorcontrib>Mismetti, Patrick</creatorcontrib><creatorcontrib>Meyer, Guy</creatorcontrib><creatorcontrib>Mismetti, Patrick</creatorcontrib><creatorcontrib>Chatellier, Gilles</creatorcontrib><creatorcontrib>Laporte, Silvy</creatorcontrib><creatorcontrib>Decousus, Hervé</creatorcontrib><creatorcontrib>Mahé, Isabelle</creatorcontrib><creatorcontrib>Falvo, Nicolas</creatorcontrib><creatorcontrib>Delluc, Aurélien</creatorcontrib><creatorcontrib>Bertoletti, Laurent</creatorcontrib><creatorcontrib>Laneau, Christine</creatorcontrib><creatorcontrib>Dinut, Aurelia</creatorcontrib><creatorcontrib>Aegerter, Philippe</creatorcontrib><creatorcontrib>Emmerich, Joseph</creatorcontrib><creatorcontrib>Girard, Philippe</creatorcontrib><creatorcontrib>Messas, Emmanuel</creatorcontrib><creatorcontrib>Revel, Marie-Pierre</creatorcontrib><creatorcontrib>Charles-Nelson, Anaïs</creatorcontrib><creatorcontrib>Acassat, Sandrine</creatorcontrib><creatorcontrib>Grange, Claire</creatorcontrib><creatorcontrib>Planquette, Benjamin</creatorcontrib><creatorcontrib>Sanchez, Olivier</creatorcontrib><creatorcontrib>Plaisance, Ludovic</creatorcontrib><creatorcontrib>Poénou, Géraldine</creatorcontrib><creatorcontrib>Pernod, Gilles</creatorcontrib><creatorcontrib>Imbert, Bernard</creatorcontrib><creatorcontrib>Zenati, Nora</creatorcontrib><creatorcontrib>Couturaud, Francis</creatorcontrib><creatorcontrib>Le Moigne, Emmanuelle</creatorcontrib><creatorcontrib>Le Mao, Raphael</creatorcontrib><creatorcontrib>Hoffmann, Clément</creatorcontrib><creatorcontrib>Elias, Antoine</creatorcontrib><creatorcontrib>Elias, Marie</creatorcontrib><creatorcontrib>Loffroy, Romaric</creatorcontrib><creatorcontrib>Jandot, Maud</creatorcontrib><creatorcontrib>Sevestre, Marie-Antoinette</creatorcontrib><creatorcontrib>Modéliar Rémond, Santhi Samy</creatorcontrib><creatorcontrib>Ray, Valérie</creatorcontrib><creatorcontrib>Burnod, Alexis</creatorcontrib><creatorcontrib>Roy, Pierre-Marie</creatorcontrib><creatorcontrib>Moumneh, Thomas</creatorcontrib><creatorcontrib>Henni, Samir</creatorcontrib><creatorcontrib>Brebion, Nicolas</creatorcontrib><creatorcontrib>Timor-David, Miruna</creatorcontrib><creatorcontrib>Constans, Joël</creatorcontrib><creatorcontrib>Boulon, Carine</creatorcontrib><creatorcontrib>Aquilanti, Sandro</creatorcontrib><creatorcontrib>Brisot, Dominique</creatorcontrib><creatorcontrib>Bura-Rivière, Alessandra</creatorcontrib><creatorcontrib>CASTA DIVA Trial Investigators</creatorcontrib><title>Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism</title><title>Chest</title><description>Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE.
Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?
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.
Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic 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).
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.
ClinicalTrials.gov; No.: NCT02746185; URL: www.clinicaltrials.gov
[Display omitted]</description><subject>Biological Physics</subject><subject>cancer</subject><subject>direct oral anticoagulants</subject><subject>low-molecular-weight heparin</subject><subject>Physics</subject><subject>pulmonary embolism</subject><subject>randomized controlled trial</subject><subject>VTE</subject><issn>0012-3692</issn><issn>1931-3543</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kM9KAzEQxoMoWKtP4KVXD7tmkt2kOYiU-hcKgtRzmM3O0pRttyTLom_js_hkplY8CjMMM3y_ge9j7BJ4DhzU9Tp3K4p9LriAnJucS33ERmAkZLIs5DEbcQ4ik8qIU3YW45qnHYwasdtXP2Do3rHC7WSIX5932Pa0w-C3k1Rz3DoK2SzGznnsqZ4sV6HbVB2lbn3cnLOTBttIF79zzN4e7pfzp2zx8vg8ny0yB1MBmXNCG-AViUY748qSVE1YuqrRhHxK2mED9VSWtQISRskCnWqgSJK6UErKMbs6_F1ha3fBbzB82A69fZot7P7GpQKthB4gaeVB60IXY6DmDwBu93nZtf3Jy-7zstwkWCfq5kBRsjF4CjY6T8l-7QO53tad_5f_BtZAdcg</recordid><startdate>202203</startdate><enddate>202203</enddate><creator>Planquette, 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vs Dalteparin in Cancer-Associated Thromboembolism</title><author>Planquette, Benjamin ; Bertoletti, Laurent ; Charles-Nelson, Anaïs ; Laporte, Silvy ; Grange, Claire ; Mahé, Isabelle ; Pernod, Gilles ; Elias, Antoine ; Couturaud, Francis ; Falvo, Nicolas ; Sevestre, Marie Antoinette ; Ray, Valérie ; Burnod, Alexis ; Brebion, Nicolas ; Roy, Pierre-Marie ; Timar-David, Miruna ; Aquilanti, Sandro ; Constans, Joel ; Bura-Rivière, Alessandra ; Brisot, Dominique ; Chatellier, Gilles ; Sanchez, Olivier ; Meyer, Guy ; Girard, Philippe ; Mismetti, Patrick ; Meyer, Guy ; Mismetti, Patrick ; Chatellier, Gilles ; Laporte, Silvy ; Decousus, Hervé ; Mahé, Isabelle ; Falvo, Nicolas ; Delluc, Aurélien ; Bertoletti, Laurent ; Laneau, Christine ; Dinut, Aurelia ; Aegerter, Philippe ; Emmerich, Joseph ; Girard, Philippe ; Messas, Emmanuel ; Revel, Marie-Pierre ; Charles-Nelson, Anaïs ; Acassat, Sandrine ; Grange, Claire ; Planquette, Benjamin ; Sanchez, Olivier ; Plaisance, Ludovic ; Poénou, Géraldine ; Pernod, Gilles ; Imbert, Bernard ; Zenati, Nora ; Couturaud, Francis ; Le Moigne, Emmanuelle ; Le Mao, Raphael ; Hoffmann, Clément ; Elias, Antoine ; Elias, Marie ; Loffroy, Romaric ; Jandot, Maud ; Sevestre, Marie-Antoinette ; Modéliar Rémond, Santhi Samy ; Ray, Valérie ; Burnod, Alexis ; Roy, Pierre-Marie ; Moumneh, Thomas ; Henni, Samir ; Brebion, Nicolas ; Timor-David, Miruna ; Constans, Joël ; Boulon, Carine ; Aquilanti, Sandro ; Brisot, Dominique ; Bura-Rivière, Alessandra</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1821-cc27910be2f7c9c55e6dea5cbf7ea08e7caf1d835d61e29634ac6f14a5cd46633</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Biological Physics</topic><topic>cancer</topic><topic>direct oral anticoagulants</topic><topic>low-molecular-weight heparin</topic><topic>Physics</topic><topic>pulmonary embolism</topic><topic>randomized controlled trial</topic><topic>VTE</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Planquette, Benjamin</creatorcontrib><creatorcontrib>Bertoletti, Laurent</creatorcontrib><creatorcontrib>Charles-Nelson, Anaïs</creatorcontrib><creatorcontrib>Laporte, Silvy</creatorcontrib><creatorcontrib>Grange, Claire</creatorcontrib><creatorcontrib>Mahé, Isabelle</creatorcontrib><creatorcontrib>Pernod, Gilles</creatorcontrib><creatorcontrib>Elias, Antoine</creatorcontrib><creatorcontrib>Couturaud, Francis</creatorcontrib><creatorcontrib>Falvo, Nicolas</creatorcontrib><creatorcontrib>Sevestre, Marie Antoinette</creatorcontrib><creatorcontrib>Ray, Valérie</creatorcontrib><creatorcontrib>Burnod, Alexis</creatorcontrib><creatorcontrib>Brebion, Nicolas</creatorcontrib><creatorcontrib>Roy, Pierre-Marie</creatorcontrib><creatorcontrib>Timar-David, Miruna</creatorcontrib><creatorcontrib>Aquilanti, Sandro</creatorcontrib><creatorcontrib>Constans, Joel</creatorcontrib><creatorcontrib>Bura-Rivière, Alessandra</creatorcontrib><creatorcontrib>Brisot, Dominique</creatorcontrib><creatorcontrib>Chatellier, Gilles</creatorcontrib><creatorcontrib>Sanchez, Olivier</creatorcontrib><creatorcontrib>Meyer, Guy</creatorcontrib><creatorcontrib>Girard, Philippe</creatorcontrib><creatorcontrib>Mismetti, Patrick</creatorcontrib><creatorcontrib>Meyer, Guy</creatorcontrib><creatorcontrib>Mismetti, Patrick</creatorcontrib><creatorcontrib>Chatellier, Gilles</creatorcontrib><creatorcontrib>Laporte, Silvy</creatorcontrib><creatorcontrib>Decousus, Hervé</creatorcontrib><creatorcontrib>Mahé, Isabelle</creatorcontrib><creatorcontrib>Falvo, Nicolas</creatorcontrib><creatorcontrib>Delluc, Aurélien</creatorcontrib><creatorcontrib>Bertoletti, Laurent</creatorcontrib><creatorcontrib>Laneau, Christine</creatorcontrib><creatorcontrib>Dinut, Aurelia</creatorcontrib><creatorcontrib>Aegerter, Philippe</creatorcontrib><creatorcontrib>Emmerich, Joseph</creatorcontrib><creatorcontrib>Girard, Philippe</creatorcontrib><creatorcontrib>Messas, Emmanuel</creatorcontrib><creatorcontrib>Revel, Marie-Pierre</creatorcontrib><creatorcontrib>Charles-Nelson, Anaïs</creatorcontrib><creatorcontrib>Acassat, Sandrine</creatorcontrib><creatorcontrib>Grange, Claire</creatorcontrib><creatorcontrib>Planquette, Benjamin</creatorcontrib><creatorcontrib>Sanchez, Olivier</creatorcontrib><creatorcontrib>Plaisance, Ludovic</creatorcontrib><creatorcontrib>Poénou, Géraldine</creatorcontrib><creatorcontrib>Pernod, Gilles</creatorcontrib><creatorcontrib>Imbert, Bernard</creatorcontrib><creatorcontrib>Zenati, Nora</creatorcontrib><creatorcontrib>Couturaud, Francis</creatorcontrib><creatorcontrib>Le Moigne, Emmanuelle</creatorcontrib><creatorcontrib>Le Mao, Raphael</creatorcontrib><creatorcontrib>Hoffmann, Clément</creatorcontrib><creatorcontrib>Elias, Antoine</creatorcontrib><creatorcontrib>Elias, Marie</creatorcontrib><creatorcontrib>Loffroy, Romaric</creatorcontrib><creatorcontrib>Jandot, Maud</creatorcontrib><creatorcontrib>Sevestre, Marie-Antoinette</creatorcontrib><creatorcontrib>Modéliar Rémond, Santhi Samy</creatorcontrib><creatorcontrib>Ray, Valérie</creatorcontrib><creatorcontrib>Burnod, Alexis</creatorcontrib><creatorcontrib>Roy, Pierre-Marie</creatorcontrib><creatorcontrib>Moumneh, Thomas</creatorcontrib><creatorcontrib>Henni, Samir</creatorcontrib><creatorcontrib>Brebion, Nicolas</creatorcontrib><creatorcontrib>Timor-David, Miruna</creatorcontrib><creatorcontrib>Constans, Joël</creatorcontrib><creatorcontrib>Boulon, Carine</creatorcontrib><creatorcontrib>Aquilanti, Sandro</creatorcontrib><creatorcontrib>Brisot, Dominique</creatorcontrib><creatorcontrib>Bura-Rivière, Alessandra</creatorcontrib><creatorcontrib>CASTA DIVA Trial Investigators</creatorcontrib><collection>CrossRef</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Chest</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Planquette, Benjamin</au><au>Bertoletti, Laurent</au><au>Charles-Nelson, Anaïs</au><au>Laporte, Silvy</au><au>Grange, Claire</au><au>Mahé, Isabelle</au><au>Pernod, Gilles</au><au>Elias, Antoine</au><au>Couturaud, Francis</au><au>Falvo, Nicolas</au><au>Sevestre, Marie Antoinette</au><au>Ray, Valérie</au><au>Burnod, Alexis</au><au>Brebion, Nicolas</au><au>Roy, Pierre-Marie</au><au>Timar-David, Miruna</au><au>Aquilanti, Sandro</au><au>Constans, Joel</au><au>Bura-Rivière, Alessandra</au><au>Brisot, Dominique</au><au>Chatellier, Gilles</au><au>Sanchez, Olivier</au><au>Meyer, Guy</au><au>Girard, Philippe</au><au>Mismetti, Patrick</au><au>Meyer, Guy</au><au>Mismetti, Patrick</au><au>Chatellier, Gilles</au><au>Laporte, Silvy</au><au>Decousus, Hervé</au><au>Mahé, Isabelle</au><au>Falvo, Nicolas</au><au>Delluc, Aurélien</au><au>Bertoletti, Laurent</au><au>Laneau, Christine</au><au>Dinut, Aurelia</au><au>Aegerter, Philippe</au><au>Emmerich, Joseph</au><au>Girard, Philippe</au><au>Messas, Emmanuel</au><au>Revel, Marie-Pierre</au><au>Charles-Nelson, Anaïs</au><au>Acassat, Sandrine</au><au>Grange, Claire</au><au>Planquette, Benjamin</au><au>Sanchez, Olivier</au><au>Plaisance, Ludovic</au><au>Poénou, Géraldine</au><au>Pernod, Gilles</au><au>Imbert, Bernard</au><au>Zenati, Nora</au><au>Couturaud, Francis</au><au>Le Moigne, Emmanuelle</au><au>Le Mao, Raphael</au><au>Hoffmann, Clément</au><au>Elias, Antoine</au><au>Elias, Marie</au><au>Loffroy, Romaric</au><au>Jandot, Maud</au><au>Sevestre, Marie-Antoinette</au><au>Modéliar Rémond, Santhi Samy</au><au>Ray, Valérie</au><au>Burnod, Alexis</au><au>Roy, Pierre-Marie</au><au>Moumneh, Thomas</au><au>Henni, Samir</au><au>Brebion, Nicolas</au><au>Timor-David, Miruna</au><au>Constans, Joël</au><au>Boulon, Carine</au><au>Aquilanti, Sandro</au><au>Brisot, Dominique</au><au>Bura-Rivière, Alessandra</au><aucorp>CASTA DIVA Trial Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism</atitle><jtitle>Chest</jtitle><date>2022-03</date><risdate>2022</risdate><volume>161</volume><issue>3</issue><spage>781</spage><epage>790</epage><pages>781-790</pages><issn>0012-3692</issn><eissn>1931-3543</eissn><abstract>Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated VTE.
Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?
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.
Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, and 115 patients (76.2%) had metastatic 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).
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.
ClinicalTrials.gov; No.: NCT02746185; URL: www.clinicaltrials.gov
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| fulltext | fulltext |
| identifier | ISSN: 0012-3692 |
| ispartof | Chest, 2022-03, Vol.161 (3), p.781-790 |
| issn | 0012-3692 1931-3543 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_03617627v1 |
| source | Alma/SFX Local Collection |
| subjects | Biological Physics cancer direct oral anticoagulants low-molecular-weight heparin Physics pulmonary embolism randomized controlled trial VTE |
| title | Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism |
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