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Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial

BACKGROUND: Although implantation of cardiac implantable electronic devices (CIEDs) in patients receiving warfarin is well studied, limited data are available on the use of oral factor Xa inhibitors in this setting. METHODS AND RESULTS: Using data from Rivaroxaban Once Daily Oral Direct Factor Xa In...

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Autores principales: Leef, George C., Hellkamp, Anne S., Patel, Manesh R., Becker, Richard C., Berkowitz, Scott D., Breithardt, Günter, Halperin, Jonathan L., Hankey, Graeme J., Hacke, Werner, Nessel, Christopher C., Singer, Daniel E., Fox, Keith A.A., Mahaffey, Kenneth W., Piccini, Jonathan P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5669143/
https://www.ncbi.nlm.nih.gov/pubmed/28615214
http://dx.doi.org/10.1161/JAHA.116.004663
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author Leef, George C.
Hellkamp, Anne S.
Patel, Manesh R.
Becker, Richard C.
Berkowitz, Scott D.
Breithardt, Günter
Halperin, Jonathan L.
Hankey, Graeme J.
Hacke, Werner
Nessel, Christopher C.
Singer, Daniel E.
Fox, Keith A.A.
Mahaffey, Kenneth W.
Piccini, Jonathan P.
author_facet Leef, George C.
Hellkamp, Anne S.
Patel, Manesh R.
Becker, Richard C.
Berkowitz, Scott D.
Breithardt, Günter
Halperin, Jonathan L.
Hankey, Graeme J.
Hacke, Werner
Nessel, Christopher C.
Singer, Daniel E.
Fox, Keith A.A.
Mahaffey, Kenneth W.
Piccini, Jonathan P.
author_sort Leef, George C.
collection PubMed
description BACKGROUND: Although implantation of cardiac implantable electronic devices (CIEDs) in patients receiving warfarin is well studied, limited data are available on the use of oral factor Xa inhibitors in this setting. METHODS AND RESULTS: Using data from Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) (n=14 264), we compared baseline characteristics and clinical outcomes in patients with atrial fibrillation randomized to rivaroxaban versus warfarin who did and did not undergo CIED implantation or revision. In this post‐hoc, postrandomization, on‐treatment analysis, only the first intervention per patient was analyzed. During a median follow‐up of 2.2 years, 453 patients (242 rivaroxaban group; 211 warfarin group) underwent de novo CIED implantation (64.2%) or revision procedures (35.8%). Patients who received CIEDs were older, more likely to be male, and more likely to have past myocardial infarction, but had similar stroke risk compared to patients who did not receive CIEDs. Most patients who received a device had study drug interrupted for the procedure and did not receive bridging anticoagulation. During the 30‐day postprocedural period, 11 patients (4.55%) in the rivaroxaban group experienced bleeding complications compared with 15 (7.13%) in the warfarin group. Thromboembolic complications occurred in 3 patients (1.26%) in the rivaroxaban group and 1 (0.48%) in the warfarin group. Event rates were too low for formal hypothesis testing. CONCLUSIONS: Bleeding and thromboembolic events were low in both rivaroxaban‐ and warfarin‐treated patients. Periprocedural use of oral factor Xa inhibitors in CIED implantation requires further study in prospective, randomized trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767.
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spelling pubmed-56691432017-11-09 Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial Leef, George C. Hellkamp, Anne S. Patel, Manesh R. Becker, Richard C. Berkowitz, Scott D. Breithardt, Günter Halperin, Jonathan L. Hankey, Graeme J. Hacke, Werner Nessel, Christopher C. Singer, Daniel E. Fox, Keith A.A. Mahaffey, Kenneth W. Piccini, Jonathan P. J Am Heart Assoc Original Research BACKGROUND: Although implantation of cardiac implantable electronic devices (CIEDs) in patients receiving warfarin is well studied, limited data are available on the use of oral factor Xa inhibitors in this setting. METHODS AND RESULTS: Using data from Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) (n=14 264), we compared baseline characteristics and clinical outcomes in patients with atrial fibrillation randomized to rivaroxaban versus warfarin who did and did not undergo CIED implantation or revision. In this post‐hoc, postrandomization, on‐treatment analysis, only the first intervention per patient was analyzed. During a median follow‐up of 2.2 years, 453 patients (242 rivaroxaban group; 211 warfarin group) underwent de novo CIED implantation (64.2%) or revision procedures (35.8%). Patients who received CIEDs were older, more likely to be male, and more likely to have past myocardial infarction, but had similar stroke risk compared to patients who did not receive CIEDs. Most patients who received a device had study drug interrupted for the procedure and did not receive bridging anticoagulation. During the 30‐day postprocedural period, 11 patients (4.55%) in the rivaroxaban group experienced bleeding complications compared with 15 (7.13%) in the warfarin group. Thromboembolic complications occurred in 3 patients (1.26%) in the rivaroxaban group and 1 (0.48%) in the warfarin group. Event rates were too low for formal hypothesis testing. CONCLUSIONS: Bleeding and thromboembolic events were low in both rivaroxaban‐ and warfarin‐treated patients. Periprocedural use of oral factor Xa inhibitors in CIED implantation requires further study in prospective, randomized trials. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767. John Wiley and Sons Inc. 2017-06-14 /pmc/articles/PMC5669143/ /pubmed/28615214 http://dx.doi.org/10.1161/JAHA.116.004663 Text en © 2017 The Authors, Bayer US LLC, and Janssen Research and Development. Published on behalf of the American Heart Association, Inc., by Wiley. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Research
Leef, George C.
Hellkamp, Anne S.
Patel, Manesh R.
Becker, Richard C.
Berkowitz, Scott D.
Breithardt, Günter
Halperin, Jonathan L.
Hankey, Graeme J.
Hacke, Werner
Nessel, Christopher C.
Singer, Daniel E.
Fox, Keith A.A.
Mahaffey, Kenneth W.
Piccini, Jonathan P.
Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial
title Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial
title_full Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial
title_fullStr Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial
title_full_unstemmed Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial
title_short Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial
title_sort safety and efficacy of rivaroxaban in patients with cardiac implantable electronic devices: observations from the rocket af trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5669143/
https://www.ncbi.nlm.nih.gov/pubmed/28615214
http://dx.doi.org/10.1161/JAHA.116.004663
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