Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort study
Background Amiodarone is an established treatment for atrial fibrillation (AF) but might interfere with the metabolism of apixaban or warfarin. Therefore, the aim was to investigate the occurrence of major bleeding among patients with AF treated with amiodarone in combination with apixaban or warfar...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-03-01
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| Series: | Open Heart |
| Online Access: | https://openheart.bmj.com/content/11/1/e002555.full |
| _version_ | 1797278844215885824 |
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| author | Christina Christersson Gorav Batra Claes Held Henrik Renlund Angelo Modica Astrid Fritz Hansson |
| author_facet | Christina Christersson Gorav Batra Claes Held Henrik Renlund Angelo Modica Astrid Fritz Hansson |
| author_sort | Christina Christersson |
| collection | DOAJ |
| description | Background Amiodarone is an established treatment for atrial fibrillation (AF) but might interfere with the metabolism of apixaban or warfarin. Therefore, the aim was to investigate the occurrence of major bleeding among patients with AF treated with amiodarone in combination with apixaban or warfarin.Methods Retrospective observational study using Swedish health registers. All patients with AF in the National Patient Register and the National Dispensed Drug Register with concomitant use of amiodarone and warfarin or apixaban between 1 June 2013 and 31 December 2018 were included. Propensity score matching was performed, and matched cohorts were compared using Cox proportional HRs. The primary outcome was major bleeding resulting in hospitalisation based on International Classification of Diseases (ICD)-10 codes. Secondary outcomes included intracranial bleeding, gastrointestinal bleeding and other bleeding. Exploratory outcomes included ischaemic stroke/systemic embolism and all-cause/cardiovascular (CV) mortality.Results A total of 12 103 patients met the inclusion criteria and 8686 patients were included after propensity score matching. Rates of major bleeding were similar in the apixaban (4.3/100 patient-years) and warfarin cohort (4.5/100 patient-years) (HR: 1.03; 95% CI: 0.76 to 1.39) during median follow-up of 4.4 months. Similar findings were observed for secondary outcomes including gastrointestinal bleeding and other bleeding, and exploratory outcomes including ischaemic stroke/systemic embolism and all-cause/CV mortality.Conclusions Among patients treated with amiodarone in combination with apixaban or warfarin, major bleeding and thromboembolic events were rare and with no significant difference between the treatment groups.EUPAS registry number EUPAS43681. |
| first_indexed | 2024-03-07T16:15:00Z |
| format | Article |
| id | doaj.art-7c343ad41ef44a2bbbabd7e005c37ec8 |
| institution | Directory Open Access Journal |
| issn | 2053-3624 |
| language | English |
| last_indexed | 2024-03-07T16:15:00Z |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Open Heart |
| spelling | doaj.art-7c343ad41ef44a2bbbabd7e005c37ec82024-03-04T11:25:09ZengBMJ Publishing GroupOpen Heart2053-36242024-03-0111110.1136/openhrt-2023-002555Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort studyChristina Christersson0Gorav Batra1Claes Held2Henrik Renlund3Angelo Modica4Astrid Fritz Hansson5Department of Medical Sciences Cardiology, Uppsala University, Uppsala, SwedenDepartment of Medical Sciences Cardiology, Uppsala University, Uppsala, SwedenUppsala Clinical Research Center, Uppsala University, Uppsala, SwedenUppsala Clinical Research Center, Uppsala University, Uppsala, SwedenPfizer AB, Stockholm, SwedenDepartment of Medical Sciences Cardiology, Uppsala University, Uppsala, SwedenBackground Amiodarone is an established treatment for atrial fibrillation (AF) but might interfere with the metabolism of apixaban or warfarin. Therefore, the aim was to investigate the occurrence of major bleeding among patients with AF treated with amiodarone in combination with apixaban or warfarin.Methods Retrospective observational study using Swedish health registers. All patients with AF in the National Patient Register and the National Dispensed Drug Register with concomitant use of amiodarone and warfarin or apixaban between 1 June 2013 and 31 December 2018 were included. Propensity score matching was performed, and matched cohorts were compared using Cox proportional HRs. The primary outcome was major bleeding resulting in hospitalisation based on International Classification of Diseases (ICD)-10 codes. Secondary outcomes included intracranial bleeding, gastrointestinal bleeding and other bleeding. Exploratory outcomes included ischaemic stroke/systemic embolism and all-cause/cardiovascular (CV) mortality.Results A total of 12 103 patients met the inclusion criteria and 8686 patients were included after propensity score matching. Rates of major bleeding were similar in the apixaban (4.3/100 patient-years) and warfarin cohort (4.5/100 patient-years) (HR: 1.03; 95% CI: 0.76 to 1.39) during median follow-up of 4.4 months. Similar findings were observed for secondary outcomes including gastrointestinal bleeding and other bleeding, and exploratory outcomes including ischaemic stroke/systemic embolism and all-cause/CV mortality.Conclusions Among patients treated with amiodarone in combination with apixaban or warfarin, major bleeding and thromboembolic events were rare and with no significant difference between the treatment groups.EUPAS registry number EUPAS43681.https://openheart.bmj.com/content/11/1/e002555.full |
| spellingShingle | Christina Christersson Gorav Batra Claes Held Henrik Renlund Angelo Modica Astrid Fritz Hansson Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort study Open Heart |
| title | Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort study |
| title_full | Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort study |
| title_fullStr | Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort study |
| title_full_unstemmed | Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort study |
| title_short | Major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone: nationwide cohort study |
| title_sort | major bleeding in patients with atrial fibrillation treated with apixaban versus warfarin in combination with amiodarone nationwide cohort study |
| url | https://openheart.bmj.com/content/11/1/e002555.full |
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