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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| Format: | Article |
| Language: | English |
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Elsevier
2021-10-01
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| Series: | Research and Practice in Thrombosis and Haemostasis |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/rth2.12607 |
| _version_ | 1827887809035239424 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-12T20:23:52Z |
| format | Article |
| id | doaj.art-db335699e1044ab696bb5ca000565e53 |
| institution | Directory Open Access Journal |
| issn | 2475-0379 |
| language | English |
| last_indexed | 2024-03-12T20:23:52Z |
| publishDate | 2021-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Research and Practice in Thrombosis and Haemostasis |
| spelling | doaj.art-db335699e1044ab696bb5ca000565e532023-08-02T00:42:00ZengElsevierResearch and Practice in Thrombosis and Haemostasis2475-03792021-10-0157n/an/a10.1002/rth2.12607Rivaroxaban in acute venous thromboembolism: UK prescribing experienceVictoria Speed0Jignesh P. Patel1Derek Cooper2Stephen Miller3Lara N. Roberts4Raj K. Patel5Roopen Arya6Department of Haematological Medicine King's Thrombosis Centre King's College Hospital NHS Foundation Trust London UKDepartment of Haematological Medicine King's Thrombosis Centre King's College Hospital NHS Foundation Trust London UKKing’s College London London UKProgeny Europe (Windward Systems Ltd.) Norfolk UKDepartment of Haematological Medicine King's Thrombosis Centre King's College Hospital NHS Foundation Trust London UKDepartment of Haematological Medicine King's Thrombosis Centre King's College Hospital NHS Foundation Trust London UKDepartment of Haematological Medicine King's Thrombosis Centre King's College Hospital NHS Foundation Trust London UKAbstract 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.https://doi.org/10.1002/rth2.12607anticoagulantsdirect‐acting oral anticoagulantpulmonary embolismrivaroxabanvenous thromboembolism |
| spellingShingle | 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 Research and Practice in Thrombosis and Haemostasis anticoagulants direct‐acting oral anticoagulant pulmonary embolism rivaroxaban venous thromboembolism |
| title | 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_short | Rivaroxaban in acute venous thromboembolism: UK prescribing experience |
| title_sort | rivaroxaban in acute venous thromboembolism uk prescribing experience |
| topic | anticoagulants direct‐acting oral anticoagulant pulmonary embolism rivaroxaban venous thromboembolism |
| url | https://doi.org/10.1002/rth2.12607 |
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