Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter: A post hoc analysis of the EURIDIS and ADONIS trials

Munveer Thind; Harry J. Crijns; Gerald V. Naccarelli; James A. Reiffel; Valerie Corp Dit Genti; Mattias Wieloch; Andrew Koren; Peter R. Kowey

doi:10.1111/jce.14405

Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter: A post hoc analysis of the EURIDIS and ADONIS trials

Munveer Thind^*, Harry J. Crijns, Gerald V. Naccarelli, James A. Reiffel, Valerie Corp Dit Genti, Mattias Wieloch, Andrew Koren, Peter R. Kowey

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Introduction The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF. Here we assessed whether patient characteristics and/or treatment outcomes in these studies differed based on the need for cardioversion before randomization.

Methods Time to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status.

Results Of 1237 patients randomized (2:1 dronedarone:placebo), 364 required baseline cardioversion (dronedarone 243, placebo 121). Patients requiring cardioversion had a greater prevalence of cardiovascular comorbidities and shorter times to first AF/AFL recurrence compared with those not requiring cardioversion. Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.59-0.97; P = .02; non-cardioversion: 150 vs 77 days, HR 0.76; 95% CI, 0.64-0.90; P <.01). Dronedarone was similarly associated with prolonged median time to symptomatic recurrence vs placebo in the cardioversion (347 vs 87 days, HR 0.65; 95% CI, 0.49-0.87) and non-cardioversion (288 vs 120 days, HR 0.74; 95% CI, 0.62-0.90) populations. Risk of cardiovascular hospitalization/death and first AF hospitalization was lower with dronedarone vs placebo regardless of cardioversion status, but differences were not statistically significant. The safety of dronedarone was similar in both groups.

Conclusion Patients requiring baseline cardioversion represent a distinct population, having more underlying cardiovascular disease and experiencing a shorter time to AF/AFL recurrences. Dronedarone was associated with improved efficacy vs placebo regardless of cardioversion status.

Original language	English
Pages (from-to)	1022-1030
Number of pages	9
Journal	Journal of Cardiovascular Electrophysiology
Volume	31
Issue number	5
DOIs	https://doi.org/10.1111/jce.14405
Publication status	Published - May 2020

Keywords

ACC/AHA/ESC 2006 GUIDELINES
AMERICAN-COLLEGE
ASSOCIATION TASK-FORCE
DOFETILIDE
EFFICACY
EURO HEART SURVEY
MAINTENANCE
MANAGEMENT
RISK-FACTORS
SINUS RHYTHM
antiarrhythmic drug
atrial fibrillation
atrial flutter
cardioversion
dronedarone
AMIODARONE
CARDIOLOGY

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10.1111/jce.14405Licence: CC BY

Cite this

Thind, M., Crijns, H. J., Naccarelli, G. V., Reiffel, J. A., Corp Dit Genti, V., Wieloch, M., Koren, A., & Kowey, P. R. (2020). Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter: A post hoc analysis of the EURIDIS and ADONIS trials. Journal of Cardiovascular Electrophysiology, 31(5), 1022-1030. https://doi.org/10.1111/jce.14405

@article{8c6c4864a8d04806aa0c3bb7e5ea6ebf,

title = "Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter: A post hoc analysis of the EURIDIS and ADONIS trials",

abstract = "Introduction The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF. Here we assessed whether patient characteristics and/or treatment outcomes in these studies differed based on the need for cardioversion before randomization.Methods Time to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status.Results Of 1237 patients randomized (2:1 dronedarone:placebo), 364 required baseline cardioversion (dronedarone 243, placebo 121). Patients requiring cardioversion had a greater prevalence of cardiovascular comorbidities and shorter times to first AF/AFL recurrence compared with those not requiring cardioversion. Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.59-0.97; P = .02; non-cardioversion: 150 vs 77 days, HR 0.76; 95% CI, 0.64-0.90; P <.01). Dronedarone was similarly associated with prolonged median time to symptomatic recurrence vs placebo in the cardioversion (347 vs 87 days, HR 0.65; 95% CI, 0.49-0.87) and non-cardioversion (288 vs 120 days, HR 0.74; 95% CI, 0.62-0.90) populations. Risk of cardiovascular hospitalization/death and first AF hospitalization was lower with dronedarone vs placebo regardless of cardioversion status, but differences were not statistically significant. The safety of dronedarone was similar in both groups.Conclusion Patients requiring baseline cardioversion represent a distinct population, having more underlying cardiovascular disease and experiencing a shorter time to AF/AFL recurrences. Dronedarone was associated with improved efficacy vs placebo regardless of cardioversion status.",

keywords = "ACC/AHA/ESC 2006 GUIDELINES, AMERICAN-COLLEGE, ASSOCIATION TASK-FORCE, DOFETILIDE, EFFICACY, EURO HEART SURVEY, MAINTENANCE, MANAGEMENT, RISK-FACTORS, SINUS RHYTHM, antiarrhythmic drug, atrial fibrillation, atrial flutter, cardioversion, dronedarone, AMIODARONE, CARDIOLOGY",

author = "Munveer Thind and Crijns, {Harry J.} and Naccarelli, {Gerald V.} and Reiffel, {James A.} and {Corp Dit Genti}, Valerie and Mattias Wieloch and Andrew Koren and Kowey, {Peter R.}",

note = "Funding Information: The authors thank all of the patients, their caregivers, and the investigators who took part in the EURIDIS and ADONIS studies. Sanofi US Inc was the sponsor of this study and was responsible for generating the data for this analysis. All authors contributed to the study concept and design, interpretation of the data, drafting/reviewing this paper, and confirming the accuracy, and approved the final manuscript for submission. Under the direction of the authors and in accordance with GPP3 guidelines, medical writing, and editorial support was provided by Meenakshi Subramanian, PhD, CMPP, Evidence Medical Affairs (Philadelphia, PA), and was funded by Sanofi US Inc. Sanofi US Inc was the sponsor of this study and was responsible for generating the data for this analysis. Funding Information: The authors thank all of the patients, their caregivers, and the investigators who took part in the EURIDIS and ADONIS studies. Sanofi US Inc was the sponsor of this study and was responsible for generating the data for this analysis. All authors contributed to the study concept and design, interpretation of the data, drafting/reviewing this paper, and confirming the accuracy, and approved the final manuscript for submission. Under the direction of the authors and in accordance with GPP3 guidelines, medical writing, and editorial support was provided by Meenakshi Subramanian, PhD, CMPP, Evidence Medical Affairs (Philadelphia, PA), and was funded by Sanofi US Inc. Sanofi US Inc was the sponsor of this study and was responsible for generating the data for this analysis. Publisher Copyright: {\textcopyright} 2020 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals, Inc.",

year = "2020",

month = may,

doi = "10.1111/jce.14405",

language = "English",

volume = "31",

pages = "1022--1030",

journal = "Journal of Cardiovascular Electrophysiology",

issn = "1045-3873",

publisher = "Wiley",

number = "5",

}

Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter: A post hoc analysis of the EURIDIS and ADONIS trials. / Thind, Munveer; Crijns, Harry J.; Naccarelli, Gerald V. et al.
In: Journal of Cardiovascular Electrophysiology, Vol. 31, No. 5, 05.2020, p. 1022-1030.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter

T2 - A post hoc analysis of the EURIDIS and ADONIS trials

AU - Thind, Munveer

AU - Crijns, Harry J.

AU - Naccarelli, Gerald V.

AU - Reiffel, James A.

AU - Corp Dit Genti, Valerie

AU - Wieloch, Mattias

AU - Koren, Andrew

AU - Kowey, Peter R.

N1 - Funding Information: The authors thank all of the patients, their caregivers, and the investigators who took part in the EURIDIS and ADONIS studies. Sanofi US Inc was the sponsor of this study and was responsible for generating the data for this analysis. All authors contributed to the study concept and design, interpretation of the data, drafting/reviewing this paper, and confirming the accuracy, and approved the final manuscript for submission. Under the direction of the authors and in accordance with GPP3 guidelines, medical writing, and editorial support was provided by Meenakshi Subramanian, PhD, CMPP, Evidence Medical Affairs (Philadelphia, PA), and was funded by Sanofi US Inc. Sanofi US Inc was the sponsor of this study and was responsible for generating the data for this analysis. Funding Information: The authors thank all of the patients, their caregivers, and the investigators who took part in the EURIDIS and ADONIS studies. Sanofi US Inc was the sponsor of this study and was responsible for generating the data for this analysis. All authors contributed to the study concept and design, interpretation of the data, drafting/reviewing this paper, and confirming the accuracy, and approved the final manuscript for submission. Under the direction of the authors and in accordance with GPP3 guidelines, medical writing, and editorial support was provided by Meenakshi Subramanian, PhD, CMPP, Evidence Medical Affairs (Philadelphia, PA), and was funded by Sanofi US Inc. Sanofi US Inc was the sponsor of this study and was responsible for generating the data for this analysis. Publisher Copyright: © 2020 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals, Inc.

PY - 2020/5

Y1 - 2020/5

N2 - Introduction The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF. Here we assessed whether patient characteristics and/or treatment outcomes in these studies differed based on the need for cardioversion before randomization.Methods Time to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status.Results Of 1237 patients randomized (2:1 dronedarone:placebo), 364 required baseline cardioversion (dronedarone 243, placebo 121). Patients requiring cardioversion had a greater prevalence of cardiovascular comorbidities and shorter times to first AF/AFL recurrence compared with those not requiring cardioversion. Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.59-0.97; P = .02; non-cardioversion: 150 vs 77 days, HR 0.76; 95% CI, 0.64-0.90; P <.01). Dronedarone was similarly associated with prolonged median time to symptomatic recurrence vs placebo in the cardioversion (347 vs 87 days, HR 0.65; 95% CI, 0.49-0.87) and non-cardioversion (288 vs 120 days, HR 0.74; 95% CI, 0.62-0.90) populations. Risk of cardiovascular hospitalization/death and first AF hospitalization was lower with dronedarone vs placebo regardless of cardioversion status, but differences were not statistically significant. The safety of dronedarone was similar in both groups.Conclusion Patients requiring baseline cardioversion represent a distinct population, having more underlying cardiovascular disease and experiencing a shorter time to AF/AFL recurrences. Dronedarone was associated with improved efficacy vs placebo regardless of cardioversion status.

AB - Introduction The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF. Here we assessed whether patient characteristics and/or treatment outcomes in these studies differed based on the need for cardioversion before randomization.Methods Time to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status.Results Of 1237 patients randomized (2:1 dronedarone:placebo), 364 required baseline cardioversion (dronedarone 243, placebo 121). Patients requiring cardioversion had a greater prevalence of cardiovascular comorbidities and shorter times to first AF/AFL recurrence compared with those not requiring cardioversion. Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.59-0.97; P = .02; non-cardioversion: 150 vs 77 days, HR 0.76; 95% CI, 0.64-0.90; P <.01). Dronedarone was similarly associated with prolonged median time to symptomatic recurrence vs placebo in the cardioversion (347 vs 87 days, HR 0.65; 95% CI, 0.49-0.87) and non-cardioversion (288 vs 120 days, HR 0.74; 95% CI, 0.62-0.90) populations. Risk of cardiovascular hospitalization/death and first AF hospitalization was lower with dronedarone vs placebo regardless of cardioversion status, but differences were not statistically significant. The safety of dronedarone was similar in both groups.Conclusion Patients requiring baseline cardioversion represent a distinct population, having more underlying cardiovascular disease and experiencing a shorter time to AF/AFL recurrences. Dronedarone was associated with improved efficacy vs placebo regardless of cardioversion status.

KW - ACC/AHA/ESC 2006 GUIDELINES

KW - AMERICAN-COLLEGE

KW - ASSOCIATION TASK-FORCE

KW - DOFETILIDE

KW - EFFICACY

KW - EURO HEART SURVEY

KW - MAINTENANCE

KW - MANAGEMENT

KW - RISK-FACTORS

KW - SINUS RHYTHM

KW - antiarrhythmic drug

KW - atrial fibrillation

KW - atrial flutter

KW - cardioversion

KW - dronedarone

KW - AMIODARONE

KW - CARDIOLOGY

U2 - 10.1111/jce.14405

DO - 10.1111/jce.14405

M3 - Article

C2 - 32083368

SN - 1045-3873

VL - 31

SP - 1022

EP - 1030

JO - Journal of Cardiovascular Electrophysiology

JF - Journal of Cardiovascular Electrophysiology

IS - 5

ER -