Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER

Background Thromboprophylaxis extended after hospital discharge in medically ill patients currently is not recommended by practice guidelines because of uncertainty about the benefit for preventing major or fatal thromboembolic events, and the risk of bleeding. Methods and Results We assessed the be...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Gary E. Raskob, Alex C. Spyropoulos, Theodore E. Spiro, Wentao Lu, Zhong Yuan, Bennett Levitan, Eunyoung Suh, Elliot S. Barnathan
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	anticoagulants bleeding rivaroxaban thromboembolism thromboprophylaxis Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/b3ae24eeae734c9d9ca797881cf8076b
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:b3ae24eeae734c9d9ca797881cf8076b
record_format	dspace
spelling	oai:doaj.org-article:b3ae24eeae734c9d9ca797881cf8076b2021-11-16T10:22:43ZBenefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER10.1161/JAHA.121.0215792047-9980https://doaj.org/article/b3ae24eeae734c9d9ca797881cf8076b2021-11-01T00:00:00Zhttps://www.ahajournals.org/doi/10.1161/JAHA.121.021579https://doaj.org/toc/2047-9980Background Thromboprophylaxis extended after hospital discharge in medically ill patients currently is not recommended by practice guidelines because of uncertainty about the benefit for preventing major or fatal thromboembolic events, and the risk of bleeding. Methods and Results We assessed the benefit and risk of thromboprophylaxis with rivaroxaban 10 mg once daily extended for 25 to 45 days after hospitalization for preventing major thromboembolism in medically ill patients using the pooled data in 16 496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post‐Discharge Venous Thrombo‐Embolism Risk) and MAGELLAN (Multicenter, randomized, parallel‐group efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically ill patients comparing rivaroxaban with enoxaparin). The data from the MARINER trial were pooled with the data from the MAGELLAN trial in patients who were free of thrombotic or bleeding events up to the last dose of enoxaparin/placebo and who continued in the outpatient phase of thromboprophylaxis. The composite outcome of major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all‐cause mortality was used to assess benefit and was compared with the risk of the composite of fatal and critical site bleeding. The incidence of the composite efficacy outcome was 1.80% (148 of 8222 patients) in the rivaroxaban group, compared with 2.31% (191 of 8274 patients in the placebo group) (HR, 0.78 [95% CI, 0.63–0.97], P=0.024). Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36; P=0.214). Conclusions The results suggest a benefit for reducing major thromboembolic outcomes (number needed to treat: 197), with a favorable trade‐off to fatal or critical site bleeding (number needed to harm: 2045). Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00571649 and NCT02111564.Gary E. RaskobAlex C. SpyropoulosTheodore E. SpiroWentao LuZhong YuanBennett LevitanEunyoung SuhElliot S. BarnathanWileyarticleanticoagulantsbleedingrivaroxabanthromboembolismthromboprophylaxisDiseases of the circulatory (Cardiovascular) systemRC666-701ENJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 10, Iss 22 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	anticoagulants bleeding rivaroxaban thromboembolism thromboprophylaxis Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	anticoagulants bleeding rivaroxaban thromboembolism thromboprophylaxis Diseases of the circulatory (Cardiovascular) system RC666-701 Gary E. Raskob Alex C. Spyropoulos Theodore E. Spiro Wentao Lu Zhong Yuan Bennett Levitan Eunyoung Suh Elliot S. Barnathan Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER
description	Background Thromboprophylaxis extended after hospital discharge in medically ill patients currently is not recommended by practice guidelines because of uncertainty about the benefit for preventing major or fatal thromboembolic events, and the risk of bleeding. Methods and Results We assessed the benefit and risk of thromboprophylaxis with rivaroxaban 10 mg once daily extended for 25 to 45 days after hospitalization for preventing major thromboembolism in medically ill patients using the pooled data in 16 496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post‐Discharge Venous Thrombo‐Embolism Risk) and MAGELLAN (Multicenter, randomized, parallel‐group efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically ill patients comparing rivaroxaban with enoxaparin). The data from the MARINER trial were pooled with the data from the MAGELLAN trial in patients who were free of thrombotic or bleeding events up to the last dose of enoxaparin/placebo and who continued in the outpatient phase of thromboprophylaxis. The composite outcome of major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all‐cause mortality was used to assess benefit and was compared with the risk of the composite of fatal and critical site bleeding. The incidence of the composite efficacy outcome was 1.80% (148 of 8222 patients) in the rivaroxaban group, compared with 2.31% (191 of 8274 patients in the placebo group) (HR, 0.78 [95% CI, 0.63–0.97], P=0.024). Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36; P=0.214). Conclusions The results suggest a benefit for reducing major thromboembolic outcomes (number needed to treat: 197), with a favorable trade‐off to fatal or critical site bleeding (number needed to harm: 2045). Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00571649 and NCT02111564.
format	article
author	Gary E. Raskob Alex C. Spyropoulos Theodore E. Spiro Wentao Lu Zhong Yuan Bennett Levitan Eunyoung Suh Elliot S. Barnathan
author_facet	Gary E. Raskob Alex C. Spyropoulos Theodore E. Spiro Wentao Lu Zhong Yuan Bennett Levitan Eunyoung Suh Elliot S. Barnathan
author_sort	Gary E. Raskob
title	Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER
title_short	Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER
title_full	Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER
title_fullStr	Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER
title_full_unstemmed	Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER
title_sort	benefit–risk of rivaroxaban for extended thromboprophylaxis after hospitalization for medical illness: pooled analysis from magellan and mariner
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/b3ae24eeae734c9d9ca797881cf8076b
work_keys_str_mv	AT garyeraskob benefitriskofrivaroxabanforextendedthromboprophylaxisafterhospitalizationformedicalillnesspooledanalysisfrommagellanandmariner AT alexcspyropoulos benefitriskofrivaroxabanforextendedthromboprophylaxisafterhospitalizationformedicalillnesspooledanalysisfrommagellanandmariner AT theodoreespiro benefitriskofrivaroxabanforextendedthromboprophylaxisafterhospitalizationformedicalillnesspooledanalysisfrommagellanandmariner AT wentaolu benefitriskofrivaroxabanforextendedthromboprophylaxisafterhospitalizationformedicalillnesspooledanalysisfrommagellanandmariner AT zhongyuan benefitriskofrivaroxabanforextendedthromboprophylaxisafterhospitalizationformedicalillnesspooledanalysisfrommagellanandmariner AT bennettlevitan benefitriskofrivaroxabanforextendedthromboprophylaxisafterhospitalizationformedicalillnesspooledanalysisfrommagellanandmariner AT eunyoungsuh benefitriskofrivaroxabanforextendedthromboprophylaxisafterhospitalizationformedicalillnesspooledanalysisfrommagellanandmariner AT elliotsbarnathan benefitriskofrivaroxabanforextendedthromboprophylaxisafterhospitalizationformedicalillnesspooledanalysisfrommagellanandmariner
_version_	1718426569234448384

Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER

Ejemplares similares