TY - JOUR
T1 - Use and outcomes of antiarrhythmic therapy in patients with atrial fibrillation receiving oral anticoagulation
T2 - Results from the ROCKET AF trial
AU - Steinberg, Benjamin A.
AU - Hellkamp, Anne S.
AU - Lokhnygina, Yuliya
AU - Halperin, Jonathan L.
AU - Breithardt, Günter
AU - Passman, Rod
AU - Hankey, Graeme J.
AU - Patel, Manesh R.
AU - Becker, Richard C.
AU - Singer, Daniel E.
AU - Hacke, Werner
AU - Berkowitz, Scott D.
AU - Nessel, Christopher C.
AU - Mahaffey, Kenneth W.
AU - Fox, Keith A.A.
AU - Califf, Robert M.
AU - Piccini, Jonathan P.
N1 - Funding Information:
Dr Steinberg was funded by NIH T-32 training grant #5 T32 HL 7101-38. However, no relationships exist related to the analysis presented. Dr Halperin has received honoraria and served as a consultant and is on an advisory board for Bayer and Johnson & Johnson. Dr Breithardt has received honoraria from Johnson & Johnson and Bayer and advisory board fees from Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Sanofi-Aventis. Dr Passman has received speaker’s bureau fees from Boehringer Ingelheim, Johnson & Johnson, and Medtronic and research support from Medtronic; he is also funded by the NIH R34 HL113404-01. Dr Hankey has received honoraria for serving on executive committees for Johnson & Johnson and Bayer. Dr Patel has received honoraria from Johnson & Johnson and Bayer HealthCare for serving on the executive committee of the ROCKET AF trial; consulting fees from Ortho-McNeil-Janssen Pharmaceuticals and Bayer HealthCare; and advisory board fees from Genzyme. Dr Becker has received research support from Bayer and Johnson & Johnson. Dr Singer is a consultant and member of a scientific advisory board for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Johnson & Johnson, and Pfizer; has an institutional research support contract with Johnson & Johnson; and served as an unpaid ROCKET AF executive committee member. Dr Hacke has received honoraria for serving on executive committees for Johnson & Johnson and Bayer. Dr Berkowitz is a full-time employee of Bayer HealthCare Pharmaceuticals. Dr Nessel is a full-time employee of Janssen Research & Development LLC. Dr Mahaffey has received grant support (significant) from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck, Momenta Pharmaceuticals, Novartis, Portola, Pozen, Regado Biotechnologies, Sanofi-Aventis, Schering-Plough (now Merck), and The Medicines Company; he has also received consulting fees (significant) from AstraZeneca and Johnson & Johnson, (modest) Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Ortho/McNeill, Pfizer, Polymedix, Sanofi-Aventis, and Schering-Plough (now Merck). Dr Fox has received grant funding and honoraria from Bayer and Johnson & Johnson. Dr Califf has received consulting fees and research funding from Johnson & Johnson; all other industry interactions are listed at www.dcri.org/about-us/conflict-of-interest . Dr Piccini has received grants for clinical research from ARCA Biopharma, Boston Scientific, GE Healthcare, Johnson & Johnson, and ResMed; he has also received consulting fees from BMS/Pfizer, Johnson & Johnson, Forest Laboratories, Medtronic, and Spectranetics.
Funding Information:
This work was supported by Janssen Research & Development LLC, Raritan, NJ, and Bayer HealthCare AG, Leverkusen, Germany.
PY - 2014/6
Y1 - 2014/6
N2 - Background Antiarrhythmic drugs (AADs) and anticoagulation are mainstays of atrial fibrillation (AF) treatment. Objective To study the use and outcomes of AAD therapy in anticoagulated patients with AF. Methods Patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation trial (N = 14,264) were stratified by AAD use at baseline: amiodarone, other AAD, or no AAD. Multivariable adjustment was performed to compare stroke, bleeding, and death across AAD groups as well as across treatment assignment (rivaroxaban or warfarin). Results Of 14,264 patients randomized, 1681 (11.8%) were treated with an AAD (1144 [8%] with amiodarone and 537 [3.8%] with other AADs). Amiodarone-treated patients were less often female (38% vs 48%), had more persistent AF (64% vs 40%), and more concomitant heart failure (71% vs 41%) than were patients receiving other AADs. Patients receiving no AAD more closely resembled amiodarone-treated patients. Time in therapeutic range was significantly lower in warfarin-treated patients receiving amiodarone than in those receiving no AAD (50% vs 58%; P <.0001). Compared with no AAD, neither amiodarone (adjusted hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.74-1.31; P =.9) nor other AADs (adjusted HR 0.66; 95% CI 0.37-1.17; P =.15) were associated with increased mortality. Similar results were observed for embolic and bleeding outcomes. Treatment effects of rivaroxaban vs warfarin in patients receiving no AAD were consistent with results from the overall trial (primary end point: adjusted HR 0.82; 95% CI 0.68-0.98; Pinteraction =.06; safety end point: adjusted HR 1.12; 95% CI 0.90-1.24; P interaction =.33). Conclusion Treatment with AADs was not associated with increased morbidity or mortality in anticoagulated patients with AF. The effect of amiodarone on outcomes in patients receiving rivaroxaban requires further investigation.
AB - Background Antiarrhythmic drugs (AADs) and anticoagulation are mainstays of atrial fibrillation (AF) treatment. Objective To study the use and outcomes of AAD therapy in anticoagulated patients with AF. Methods Patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation trial (N = 14,264) were stratified by AAD use at baseline: amiodarone, other AAD, or no AAD. Multivariable adjustment was performed to compare stroke, bleeding, and death across AAD groups as well as across treatment assignment (rivaroxaban or warfarin). Results Of 14,264 patients randomized, 1681 (11.8%) were treated with an AAD (1144 [8%] with amiodarone and 537 [3.8%] with other AADs). Amiodarone-treated patients were less often female (38% vs 48%), had more persistent AF (64% vs 40%), and more concomitant heart failure (71% vs 41%) than were patients receiving other AADs. Patients receiving no AAD more closely resembled amiodarone-treated patients. Time in therapeutic range was significantly lower in warfarin-treated patients receiving amiodarone than in those receiving no AAD (50% vs 58%; P <.0001). Compared with no AAD, neither amiodarone (adjusted hazard ratio [HR] 0.98; 95% confidence interval [CI] 0.74-1.31; P =.9) nor other AADs (adjusted HR 0.66; 95% CI 0.37-1.17; P =.15) were associated with increased mortality. Similar results were observed for embolic and bleeding outcomes. Treatment effects of rivaroxaban vs warfarin in patients receiving no AAD were consistent with results from the overall trial (primary end point: adjusted HR 0.82; 95% CI 0.68-0.98; Pinteraction =.06; safety end point: adjusted HR 1.12; 95% CI 0.90-1.24; P interaction =.33). Conclusion Treatment with AADs was not associated with increased morbidity or mortality in anticoagulated patients with AF. The effect of amiodarone on outcomes in patients receiving rivaroxaban requires further investigation.
KW - Antiarrhythmic drugs
KW - Atrial fibrillation
KW - Outcomes
KW - Rivaroxaban
KW - Warfarin
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U2 - 10.1016/j.hrthm.2014.03.006
DO - 10.1016/j.hrthm.2014.03.006
M3 - Article
C2 - 24833235
AN - SCOPUS:84901603918
SN - 1547-5271
VL - 11
SP - 925
EP - 932
JO - Heart rhythm
JF - Heart rhythm
IS - 6
ER -