Early or delayed cardioversion in recent-onset atrial fibrillation

N.A.H.A. Pluymaekers; E.A.M.P. Dudink; J.G.L.M. Luermans; J.G. Meeder; T. Lenderink; J. Widdershoven; J.J.J. Bucx; M. Rienstra; J.M. Van Opstal; M. Alings; A. Oomen; C.J. Kirchhof; Vincent F. van Dijk; H. Ramanna; A. Liem; L.R. Dekker; B.A.B. Essers; J.G.P. Tijssen; I.C. Van Gelder; H.J.G.M. Crijns

doi:10.1056/NEJMoa1900353

Early or delayed cardioversion in recent-onset atrial fibrillation

N.A.H.A. Pluymaekers, E.A.M.P. Dudink, J.G.L.M. Luermans, J.G. Meeder, T. Lenderink, J. Widdershoven, J.J.J. Bucx, M. Rienstra, J.M. Van Opstal, M. Alings, A. Oomen, C.J. Kirchhof, Vincent F. van Dijk, H. Ramanna, A. Liem, L.R. Dekker, B.A.B. Essers, J.G.P. Tijssen, I.C. Van Gelder, H.J.G.M. Crijns (Corresponding author)

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Abstract

BACKGROUND Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the earlycardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the earlycardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks.

Original language	English
Pages (from-to)	1499-1508
Number of pages	10
Journal	The New England Journal of Medicine
Volume	380
Issue number	16
DOIs	https://doi.org/10.1056/NEJMoa1900353
Publication status	Published - 18 Apr 2019

Funding

Staff members of the independent Clinical Trial Center Maastricht performed the trial monitoring and data management. The trial was supported by the Netherlands Organization for Health Research and Development–Health Care Efficiency Research Program and Maastricht University Medical Center. Boehringer Ingelheim provided some devices for remote monitoring of patients by electrocardiography (ECG) but had no role in the design or execution of the trial; company representatives did not review the protocol or the manuscript. Investigators from the Department of Cardiology affiliated with the Heart and Vascular Center at the Maastricht University Medical Center designed the trial, collected and managed the data, and performed the statistical analyses. The writing committee wrote the manuscript, and all the steering committee members made the decision to submit it for publication. The authors had unrestricted access to the data and vouch for the accuracy and completeness of the data and analyses and for the fidelity of the trial to the protocol. Supported by a grant (837002524) from the Netherlands Organization for Health Research and Development–Health Care Efficiency Research Program and by the Maastricht University Medical Center. Boehringer Ingelheim provided some of the remote monitoring devices. Dr. Alings reports receiving advisory board fees from Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Boehringer Ingelheim, and Milestone Pharmaceuticals, lecture fees from Pfizer, and grant support from Sanofi. No other potential conflict of interest relevant to this article was reported.

Keywords

Adrenergic beta-Antagonists/therapeutic use
Aged
Anti-Arrhythmia Agents/adverse effects
Atrial Fibrillation/drug therapy
Calcium Channel Blockers/therapeutic use
Digoxin/therapeutic use
Electric Countershock/adverse effects
Emergency Service, Hospital
Female
Heart Rate
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Quality of Life
Recurrence
Time-to-Treatment
Treatment Outcome

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Pluymaekers, N. A. H. A., Dudink, E. A. M. P., Luermans, J. G. L. M., Meeder, J. G., Lenderink, T., Widdershoven, J., Bucx, J. J. J., Rienstra, M., Van Opstal, J. M., Alings, M., Oomen, A., Kirchhof, C. J., van Dijk, V. F., Ramanna, H., Liem, A., Dekker, L. R., Essers, B. A. B., Tijssen, J. G. P., Van Gelder, I. C., & Crijns, H. J. G. M. (2019). Early or delayed cardioversion in recent-onset atrial fibrillation. The New England Journal of Medicine, 380(16), 1499-1508. https://doi.org/10.1056/NEJMoa1900353

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abstract = "BACKGROUND Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the earlycardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the earlycardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks.",

keywords = "Adrenergic beta-Antagonists/therapeutic use, Aged, Anti-Arrhythmia Agents/adverse effects, Atrial Fibrillation/drug therapy, Calcium Channel Blockers/therapeutic use, Digoxin/therapeutic use, Electric Countershock/adverse effects, Emergency Service, Hospital, Female, Heart Rate, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Quality of Life, Recurrence, Time-to-Treatment, Treatment Outcome",

author = "N.A.H.A. Pluymaekers and E.A.M.P. Dudink and J.G.L.M. Luermans and J.G. Meeder and T. Lenderink and J. Widdershoven and J.J.J. Bucx and M. Rienstra and {Van Opstal}, J.M. and M. Alings and A. Oomen and C.J. Kirchhof and {van Dijk}, {Vincent F.} and H. Ramanna and A. Liem and L.R. Dekker and B.A.B. Essers and J.G.P. Tijssen and {Van Gelder}, I.C. and H.J.G.M. Crijns",

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day = "18",

doi = "10.1056/NEJMoa1900353",

language = "English",

volume = "380",

pages = "1499--1508",

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Pluymaekers, NAHA, Dudink, EAMP, Luermans, JGLM, Meeder, JG, Lenderink, T, Widdershoven, J, Bucx, JJJ, Rienstra, M, Van Opstal, JM, Alings, M, Oomen, A, Kirchhof, CJ, van Dijk, VF, Ramanna, H, Liem, A, Dekker, LR, Essers, BAB, Tijssen, JGP, Van Gelder, IC & Crijns, HJGM 2019, 'Early or delayed cardioversion in recent-onset atrial fibrillation', The New England Journal of Medicine, vol. 380, no. 16, pp. 1499-1508. https://doi.org/10.1056/NEJMoa1900353

TY - JOUR

T1 - Early or delayed cardioversion in recent-onset atrial fibrillation

AU - Pluymaekers, N.A.H.A.

AU - Dudink, E.A.M.P.

AU - Luermans, J.G.L.M.

AU - Meeder, J.G.

AU - Lenderink, T.

AU - Widdershoven, J.

AU - Bucx, J.J.J.

AU - Rienstra, M.

AU - Van Opstal, J.M.

AU - Alings, M.

AU - Oomen, A.

AU - Kirchhof, C.J.

AU - van Dijk, Vincent F.

AU - Ramanna, H.

AU - Liem, A.

AU - Dekker, L.R.

AU - Essers, B.A.B.

AU - Tijssen, J.G.P.

AU - Van Gelder, I.C.

AU - Crijns, H.J.G.M.

PY - 2019/4/18

Y1 - 2019/4/18

N2 - BACKGROUND Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the earlycardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the earlycardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks.

AB - BACKGROUND Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the earlycardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the earlycardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks.

KW - Adrenergic beta-Antagonists/therapeutic use

KW - Aged

KW - Anti-Arrhythmia Agents/adverse effects

KW - Atrial Fibrillation/drug therapy

KW - Calcium Channel Blockers/therapeutic use

KW - Digoxin/therapeutic use

KW - Electric Countershock/adverse effects

KW - Emergency Service, Hospital

KW - Female

KW - Heart Rate

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Quality of Life

KW - Recurrence

KW - Time-to-Treatment

KW - Treatment Outcome

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U2 - 10.1056/NEJMoa1900353

DO - 10.1056/NEJMoa1900353

M3 - Article

C2 - 30883054

AN - SCOPUS:85063791950

SN - 0028-4793

VL - 380

SP - 1499

EP - 1508

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

IS - 16

ER -

Early or delayed cardioversion in recent-onset atrial fibrillation

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