Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial
Background The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain. Hypothesis We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement...
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| Published in: | Clinical cardiology (Mahwah, N.J.) Vol. 42; no. 5; pp. 568 - 571 |
|---|---|
| Main Authors: | , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
New York
Wiley Periodicals, Inc
01.05.2019
John Wiley & Sons, Inc |
| Subjects: | |
| ISSN: | 0160-9289, 1932-8737, 1932-8737 |
| Online Access: | Get full text |
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| Abstract | Background
The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain.
Hypothesis
We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair.
Methods
Using data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model.
Results
In ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes.
Conclusions
In patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed.
ClinicalTrials.gov
NCT00412984. |
|---|---|
| AbstractList | Background
The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain.
Hypothesis
We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair.
Methods
Using data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model.
Results
In ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes.
Conclusions
In patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed.
ClinicalTrials.gov
NCT00412984. The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain.BACKGROUNDThe optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain.We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair.HYPOTHESISWe evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair.Using data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model.METHODSUsing data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model.In ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes.RESULTSIn ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes.In patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed. CLINICALTRIALS.GOV: NCT00412984.CONCLUSIONSIn patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed. CLINICALTRIALS.GOV: NCT00412984. The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain. We evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair. Using data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model. In ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes. In patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed. CLINICALTRIALS.GOV: NCT00412984. BackgroundThe optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains uncertain.HypothesisWe evaluated the safety and efficacy of apixaban vs warfarin in patients with AF and a history of BPV replacement or native valve repair.MethodsUsing data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) (n = 18 201), a randomized trial comparing apixaban with warfarin in patients with AF, we analyzed the subgroup of patients (n = 251) with prior valve surgery. We contacted sites by telephone to obtain additional data about prior valve surgery. Full data were available for 156 patients. The primary efficacy endpoint was stroke/systemic embolism. The primary safety endpoint was major bleeding. Treatment groups were compared using a Cox regression model.ResultsIn ARISTOTLE, 104 (0.6%) patients had a history of BPV replacement (n = 73 [aortic], n = 26 [mitral], n = 5 [mitral and aortic]) and 52 (0.3%) had a history of valve repair (n = 50 [mitral], n = 2 [aortic]). Among patients with BPVs, 55 were randomized to apixaban and 49 to warfarin. Among those with a history of native valve repair, 32 were randomized to apixaban and 20 to warfarin. Overall clinical event rates were low, with no significant differences between apixaban and warfarin for any outcomes.ConclusionsIn patients with AF and a history of BPV replacement or repair, the safety and efficacy of apixaban compared with warfarin was consistent with results from ARISTOTLE. These data suggest that apixaban may be reasonable for patients with BPVs or prior valve repair, though future larger randomized trials are needed.ClinicalTrials.govNCT00412984. |
| Author | Pokorney, Sean D. Giczewska, Anna Hanna, Michael Vinereanu, Dragos Wojdyla, Daniel M. Alexander, John H. Granger, Christopher B. Lewis, Basil S. Wallentin, Lars Carnicelli, Anthony Lopes, Renato D. Gersh, Bernard J. Guimarães, Patricia O. |
| AuthorAffiliation | 1 Duke Clinical Research Institute Duke University School of Medicine Durham North Carolina 3 Department of Biomedical Engineering, Faculty of Electronics Telecommunications and Informatics, Gdansk University of Technology Poland 7 Department of Cardiology University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital Bucharest Romania 5 Bristol‐Myers Squibb Princeton New Jersey 4 Department of Cardiovascular Medicine Lady Davis Carmel Medical Center Haifa Israel 2 Division of Cardiovascular Diseases Mayo Clinic College of Medicine Rochester Minnesota 6 Uppsala Clinical Research Center, Department of Medical Sciences, Cardiology Uppsala University Uppsala Sweden |
| AuthorAffiliation_xml | – name: 5 Bristol‐Myers Squibb Princeton New Jersey – name: 6 Uppsala Clinical Research Center, Department of Medical Sciences, Cardiology Uppsala University Uppsala Sweden – name: 2 Division of Cardiovascular Diseases Mayo Clinic College of Medicine Rochester Minnesota – name: 4 Department of Cardiovascular Medicine Lady Davis Carmel Medical Center Haifa Israel – name: 1 Duke Clinical Research Institute Duke University School of Medicine Durham North Carolina – name: 3 Department of Biomedical Engineering, Faculty of Electronics Telecommunications and Informatics, Gdansk University of Technology Poland – name: 7 Department of Cardiology University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital Bucharest Romania |
| Author_xml | – sequence: 1 givenname: Patricia O. surname: Guimarães fullname: Guimarães, Patricia O. organization: Duke University School of Medicine – sequence: 2 givenname: Sean D. surname: Pokorney fullname: Pokorney, Sean D. organization: Duke University School of Medicine – sequence: 3 givenname: Renato D. orcidid: 0000-0003-2999-4961 surname: Lopes fullname: Lopes, Renato D. email: renato.lopes@dm.duke.edu organization: Duke University School of Medicine – sequence: 4 givenname: Daniel M. surname: Wojdyla fullname: Wojdyla, Daniel M. organization: Duke University School of Medicine – sequence: 5 givenname: Bernard J. surname: Gersh fullname: Gersh, Bernard J. organization: Mayo Clinic College of Medicine – sequence: 6 givenname: Anna surname: Giczewska fullname: Giczewska, Anna organization: Telecommunications and Informatics, Gdansk University of Technology – sequence: 7 givenname: Anthony surname: Carnicelli fullname: Carnicelli, Anthony organization: Duke University School of Medicine – sequence: 8 givenname: Basil S. surname: Lewis fullname: Lewis, Basil S. organization: Lady Davis Carmel Medical Center – sequence: 9 givenname: Michael surname: Hanna fullname: Hanna, Michael organization: Bristol‐Myers Squibb – sequence: 10 givenname: Lars surname: Wallentin fullname: Wallentin, Lars organization: Uppsala University – sequence: 11 givenname: Dragos surname: Vinereanu fullname: Vinereanu, Dragos organization: University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital – sequence: 12 givenname: John H. surname: Alexander fullname: Alexander, John H. organization: Duke University School of Medicine – sequence: 13 givenname: Christopher B. surname: Granger fullname: Granger, Christopher B. organization: Duke University School of Medicine |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30907005$$D View this record in MEDLINE/PubMed https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-387295$$DView record from Swedish Publication Index (Uppsala universitet) |
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| Cites_doi | 10.1161/CIRCULATIONAHA.116.026793 10.1056/NEJMoa1107039 10.1161/CIRCULATIONAHA.114.014807 10.1093/eurheartj/ehu352 10.1161/CIRCULATIONAHA.116.026714 |
| ContentType | Journal Article |
| Copyright | 2019 The Authors. published by Wiley Periodicals, Inc. 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc. 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| DOI | 10.1002/clc.23178 |
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| Keywords | bioprosthetic valves atrial fibrillation apixaban valve repair |
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| License | Attribution 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
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| Notes | Funding information Bristol‐Myers Squibb; Pfizer ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 These authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. Michael Hanna is the Employee of Bristol‐Myers Squibb at the time of study conduct. Funding information Bristol‐Myers Squibb; Pfizer |
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| References | 2017; 135 2014; 35 2011; 365 2015; 132 e_1_2_6_3_1 e_1_2_6_2_1 e_1_2_6_5_1 e_1_2_6_4_1 e_1_2_6_6_1 |
| References_xml | – volume: 135 start-page: 714 year: 2017 end-page: 716 article-title: Direct oral anticoagulants in patients with atrial fibrillation and valvular heart disease other than significant mitral stenosis and mechanical valves: a meta‐analysis publication-title: Circulation – volume: 132 start-page: 624 year: 2015 end-page: 632 article-title: Apixaban in comparison with warfarin in patients with atrial fibrillation and valvular heart disease: findings from the apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation (ARISTOTLE) trial publication-title: Circulation – volume: 35 start-page: 3328 year: 2014 end-page: 3335 article-title: What is 'valvular' atrial fibrillation? A reappraisal publication-title: Eur Heart J – volume: 365 start-page: 981 year: 2011 end-page: 992 article-title: Apixaban versus warfarin in patients with atrial fibrillation publication-title: N Engl J Med – volume: 135 start-page: 1273 year: 2017 end-page: 1275 article-title: Edoxaban for the prevention of thromboembolism in patients with atrial fibrillation and bioprosthetic valves publication-title: Circulation – ident: e_1_2_6_3_1 doi: 10.1161/CIRCULATIONAHA.116.026793 – ident: e_1_2_6_5_1 doi: 10.1056/NEJMoa1107039 – ident: e_1_2_6_6_1 doi: 10.1161/CIRCULATIONAHA.114.014807 – ident: e_1_2_6_2_1 doi: 10.1093/eurheartj/ehu352 – ident: e_1_2_6_4_1 doi: 10.1161/CIRCULATIONAHA.116.026714 |
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| Snippet | Background
The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair... The optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair remains... BackgroundThe optimal anticoagulation strategy for patients with atrial fibrillation (AF) and bioprosthetic valve (BPV) replacement or native valve repair... |
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| StartPage | 568 |
| SubjectTerms | Aged Anticoagulants Anticoagulants - adverse effects Anticoagulants - therapeutic use apixaban atrial fibrillation Atrial Fibrillation - complications Atrial Fibrillation - diagnosis Atrial Fibrillation - drug therapy Bioprosthesis bioprosthetic valves Cardiac arrhythmia Catheters Clinical Investigations Factor Xa Inhibitors - adverse effects Factor Xa Inhibitors - therapeutic use Female Heart Valve Prosthesis Heart Valve Prosthesis Implantation - adverse effects Heart Valve Prosthesis Implantation - instrumentation Heart Valves - surgery Hemorrhage - chemically induced Humans Male Middle Aged Pyrazoles - adverse effects Pyrazoles - therapeutic use Pyridones - adverse effects Pyridones - therapeutic use Risk Factors Stroke - diagnosis Stroke - etiology Stroke - prevention & control Time Factors Treatment Outcome valve repair Warfarin - adverse effects Warfarin - therapeutic use |
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| Title | Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial |
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