Rivaroxaban in acute venous thromboembolism: UK prescribing experience

Abstract Background Rivaroxaban was reported as effective as traditional therapies for the acute treatment of venous thromboembolism (VTE) with fewer major bleeding complications in the seminal Einstein program and is now a recommended option for the treatment of VTE around the world. Objective To r...

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Autores principales:	Victoria Speed, Jignesh P. Patel, Derek Cooper, Stephen Miller, Lara N. Roberts, Raj K. Patel, Roopen Arya
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	anticoagulants direct‐acting oral anticoagulant pulmonary embolism rivaroxaban venous thromboembolism Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/db335699e1044ab696bb5ca000565e53
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spelling	oai:doaj.org-article:db335699e1044ab696bb5ca000565e532021-11-29T09:35:28ZRivaroxaban in acute venous thromboembolism: UK prescribing experience2475-037910.1002/rth2.12607https://doaj.org/article/db335699e1044ab696bb5ca000565e532021-10-01T00:00:00Zhttps://doi.org/10.1002/rth2.12607https://doaj.org/toc/2475-0379Abstract Background Rivaroxaban was reported as effective as traditional therapies for the acute treatment of venous thromboembolism (VTE) with fewer major bleeding complications in the seminal Einstein program and is now a recommended option for the treatment of VTE around the world. Objective To report the safety and efficacy of rivaroxaban in daily care for the management of acute VTE in the United Kingdom. Patients/Method The FIRST registry is a UK‐only, multicenter, noninterventional, observational VTE study (NCT 02248610). Consecutive patients diagnosed with acute VTE, managed with rivaroxaban, were recruited and followed for up to 5 years. The primary outcomes were treatment‐emergent symptomatic objectively diagnosed recurrent VTE, major and clinically relevant nonmajor bleeding (CRNMB), and all‐cause mortality. Results A total of 1262 participants were recruited between 2014 and 2018. Participants were heterogeneous, with age range 18 to 95 years, weight 35 to 234 kg, and maximum body mass index 64.4 kg/m2. The median duration of treatment exposure was 135 days (interquartile range [IQR], 84‐307) and overall follow‐up 497 days (IQR, 175‐991). There were seven episodes of symptomatic VTE recurrence, 0.6%, (0.74/100 patient‐years; 95% confidence interval [CI], 0.19‐1.28). There were 79 of 1239 (6.4%), 8.66 of 100 patient‐years (95% CI, 6.90‐10.73) first episodes of major or CRNMB, which were most frequently reported by women aged <50 years as abnormal vaginal bleeding. Conclusions Rivaroxaban is an effective and safe single drug modality for the treatment of VTE in daily practice in the United Kingdom. Data to determine the optimal anticoagulation therapy for women of childbearing age are needed.Victoria SpeedJignesh P. PatelDerek CooperStephen MillerLara N. RobertsRaj K. PatelRoopen AryaWileyarticleanticoagulantsdirect‐acting oral anticoagulantpulmonary embolismrivaroxabanvenous thromboembolismDiseases of the blood and blood-forming organsRC633-647.5ENResearch and Practice in Thrombosis and Haemostasis, Vol 5, Iss 7, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	anticoagulants direct‐acting oral anticoagulant pulmonary embolism rivaroxaban venous thromboembolism Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	anticoagulants direct‐acting oral anticoagulant pulmonary embolism rivaroxaban venous thromboembolism Diseases of the blood and blood-forming organs RC633-647.5 Victoria Speed Jignesh P. Patel Derek Cooper Stephen Miller Lara N. Roberts Raj K. Patel Roopen Arya Rivaroxaban in acute venous thromboembolism: UK prescribing experience
description	Abstract Background Rivaroxaban was reported as effective as traditional therapies for the acute treatment of venous thromboembolism (VTE) with fewer major bleeding complications in the seminal Einstein program and is now a recommended option for the treatment of VTE around the world. Objective To report the safety and efficacy of rivaroxaban in daily care for the management of acute VTE in the United Kingdom. Patients/Method The FIRST registry is a UK‐only, multicenter, noninterventional, observational VTE study (NCT 02248610). Consecutive patients diagnosed with acute VTE, managed with rivaroxaban, were recruited and followed for up to 5 years. The primary outcomes were treatment‐emergent symptomatic objectively diagnosed recurrent VTE, major and clinically relevant nonmajor bleeding (CRNMB), and all‐cause mortality. Results A total of 1262 participants were recruited between 2014 and 2018. Participants were heterogeneous, with age range 18 to 95 years, weight 35 to 234 kg, and maximum body mass index 64.4 kg/m2. The median duration of treatment exposure was 135 days (interquartile range [IQR], 84‐307) and overall follow‐up 497 days (IQR, 175‐991). There were seven episodes of symptomatic VTE recurrence, 0.6%, (0.74/100 patient‐years; 95% confidence interval [CI], 0.19‐1.28). There were 79 of 1239 (6.4%), 8.66 of 100 patient‐years (95% CI, 6.90‐10.73) first episodes of major or CRNMB, which were most frequently reported by women aged <50 years as abnormal vaginal bleeding. Conclusions Rivaroxaban is an effective and safe single drug modality for the treatment of VTE in daily practice in the United Kingdom. Data to determine the optimal anticoagulation therapy for women of childbearing age are needed.
format	article
author	Victoria Speed Jignesh P. Patel Derek Cooper Stephen Miller Lara N. Roberts Raj K. Patel Roopen Arya
author_facet	Victoria Speed Jignesh P. Patel Derek Cooper Stephen Miller Lara N. Roberts Raj K. Patel Roopen Arya
author_sort	Victoria Speed
title	Rivaroxaban in acute venous thromboembolism: UK prescribing experience
title_short	Rivaroxaban in acute venous thromboembolism: UK prescribing experience
title_full	Rivaroxaban in acute venous thromboembolism: UK prescribing experience
title_fullStr	Rivaroxaban in acute venous thromboembolism: UK prescribing experience
title_full_unstemmed	Rivaroxaban in acute venous thromboembolism: UK prescribing experience
title_sort	rivaroxaban in acute venous thromboembolism: uk prescribing experience
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/db335699e1044ab696bb5ca000565e53
work_keys_str_mv	AT victoriaspeed rivaroxabaninacutevenousthromboembolismukprescribingexperience AT jigneshppatel rivaroxabaninacutevenousthromboembolismukprescribingexperience AT derekcooper rivaroxabaninacutevenousthromboembolismukprescribingexperience AT stephenmiller rivaroxabaninacutevenousthromboembolismukprescribingexperience AT laranroberts rivaroxabaninacutevenousthromboembolismukprescribingexperience AT rajkpatel rivaroxabaninacutevenousthromboembolismukprescribingexperience AT roopenarya rivaroxabaninacutevenousthromboembolismukprescribingexperience
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Rivaroxaban in acute venous thromboembolism: UK prescribing experience

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