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Early Or Delayed Cardioversion in Recent-Onset Atrial Fibrillation

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Early Or Delayed Cardioversion in Recent-Onset Atrial Fibrillation The new england journal of medicine Original Article 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, O. Kamp, J.M. Van Opstal, M. Alings, A. Oomen, C.J. Kirchhof, V.F. Van Dijk, H. Ramanna, A. Liem, L.R. Dekker, B.A.B. Essers, J.G.P. Tijssen, I.C. Van Gelder, and H.J.G.M. Crijns, for the RACE 7 ACWAS Investigators*​​ ABSTRACT BACKGROUND Patients with recent-onset atrial fibrillation commonly undergo immediate restora- The authors’ full names, academic degrees, tion of sinus rhythm by pharmacologic or electrical cardioversion. However, whether and affiliations are listed in the Appen- dix. Address reprint requests to Dr. Crijns immediate restoration of sinus rhythm is necessary is not known, since atrial fibril- at the Department of Cardiology, Maas- lation often terminates spontaneously. tricht University Medical Center, P. Debye- laan 25, 6229 HX Maastricht, the Nether- METHODS lands, or at hjgm . crijns@ mumc . nl. In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned *A complete list of investigators in the patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial RACE 7 ACWAS trial is provided in the fibrillation in the emergency department to be treated with a wait-and-see approach Supplementary Appendix, available at (delayed-cardioversion group) or early cardioversion. The wait-and-see approach in- NEJM.org. volved initial treatment with rate-control medication only and delayed cardioversion Drs. Pluymaekers and Dudink contributed if the atrial fibrillation did not resolve within 48 hours. The primary end point was equally to this article. the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower This article was published on March 18, limit of the 95% confidence interval for the between-group difference in the primary 2019, at NEJM.org. end point in percentage points was more than −10. DOI: 10.1056/NEJMoa1900353 Copyright © 2019 Massachusetts Medical Society. 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 early- cardioversion 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 pa- tients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early- cardioversion group. Within 4 weeks after randomization, cardiovascular compli- cations 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. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753.) n engl j med nejm.org 1 The New England Journal of Medicine Downloaded from nejm.org by JESUS DE JUAN MONTIEL on March 18, 2019. For personal use only. No other uses without permission. Copyright © 2019 Massachusetts Medical Society. All rights reserved. The new england journal of medicine atients with recent-onset, symptom- to submit it for publication. The authors had un- atic atrial fibrillation commonly undergo restricted access to the data and vouch for the Pimmediate restoration of sinus rhythm by accuracy and completeness of the data and analy- means of pharmacologic or electrical cardiover- ses and for the fidelity of the trial to the protocol. sion.1-3 However, it is questionable whether im- mediate restoration of sinus rhythm is necessary, Patients since atrial fibrillation often terminates sponta- From October 2014 through September 2018, we neously.4-9 Alternatively, a wait-and-see approach enrolled adults (≥18 years of age) who had pre- that includes the administration of rate-control sented to the emergency department with hemo- medication and delayed cardioversion only if nec- dynamically stable, symptomatic, recent-onset essary may avoid hospitalization and overtreat- (<36 hours), first-detected or recurrent atrial fi- ment. Therefore, we conducted a multicenter, brillation, without signs of myocardial ischemia randomized trial, RACE 7 ACWAS (Rate Control or a history of persistent atrial fibrillation (for the versus Electrical Cardioversion Trial 7–Acute Car- purpose of this trial defined as lasting for >48 dioversion versus Wait and See), to find out wheth- hours). All the patients qualified as being candi- er a wait-and-see approach would be noninferior dates for either a wait-and-see approach or early to early cardioversion for obtaining sinus rhythm. cardioversion. Previous cardioversion did not ex- clude a patient from the trial. Details regarding Methods the inclusion and exclusion criteria are provided in Table S1 in the Supplementary Appendix, avail- Trial Oversight able at NEJM.org. We conducted this noninferiority trial in the car- diology departments of 15 hospitals in the Neth- Randomization and Treatment erlands, including 3 academic hospitals, 8 non- Patients were randomly assigned in a 1:1 ratio to academic teaching hospitals, and 4 nonteaching the wait-and-see approach (delayed-cardioversion hospitals. The trial was initiated by the investiga- group) or to standard care of early cardioversion tors and coordinated by the Maastricht University (early-cardioversion group). Randomization was Medical Center. The trial was approved by the performed with the use of a centralized Web-based institutional review board at the medical center; system. Patients and attending physicians were the review board at each of the participating sites aware of the trial-group assignments. approved the protocol (available with the full text The wait-and-see approach consisted of the of this article at NEJM.org). A detailed overview administration of rate-control medication, in- of the trial design has been reported previously.10 cluding intravenous or oral β-adrenergic–recep- All the patients provided written informed consent. tor blocking agents, nondihydropyridine calcium- Staff members of the independent Clinical channel blockers, or digoxin. These medications Trial Center Maastricht performed the trial moni- were given in increasing doses to obtain relief of toring and data management. The trial was sup- symptoms and a heart rate of 110 beats per min- ported by the Netherlands Organization for Health ute or less.11 Patients were discharged when their Research and Development–Health Care Efficiency condition was determined to be clinically stable. Research Program and Maastricht University Med- An outpatient clinic visit was planned for the next ical Center. Boehringer Ingelheim provided some day, as close as possible to 48 hours after the devices for remote monitoring of patients by onset of symptoms. At this visit, the heart rhythm electrocardiography (ECG) but had no role in the was reassessed on a 12-lead ECG. If atrial fibril- design or execution of the trial; company represen- lation was still present, patients were referred to tatives did not review the protocol or the manu- the emergency department for delayed cardio- script. Investigators from the Department of Cardi- version. ology affiliated with the Heart and Vascular Center Early cardioversion consisted of pharmacolog- at the Maastricht University Medical Center de- ic cardioversion, preferably with flecainide. Elec- signed the trial, collected and managed the data, trical cardioversion was performed in patients with and performed the statistical analyses. The writ- contraindications to pharmacologic cardioversion ing committee wrote the manuscript, and all the and in patients with previous or current unsuc- steering committee members made the decision cessful pharmacologic cardioversion. Patients were 2 n engl j med nejm.org The New England Journal of Medicine Downloaded from nejm.org by JESUS DE JUAN MONTIEL on March 18, 2019. For personal use only. No other uses without permission. Copyright © 2019 Massachusetts Medical Society. All rights reserved. Early or Delayed Cardioversion in Atrial Fibrillation discharged when their condition was determined of atrial fibrillation. Cardiovascular complications to be clinically stable. were defined as events leading to an emergency In patients with a high risk of stroke who had department visit or hospital admission and in- not received previous anticoagulation, such treat- cluded heart failure, ischemic stroke, transient ment was initiated before or immediately after ischemic attack, unstable angina or acute coronary cardioversion.1,12 Transesophageal echocardiogra- syndrome, symptomatic bradycardia or tachycar- phy was not performed in any patient. Long-term dia, or hypotension. At the 4-week follow-up visit, oral anticoagulation was continued in accordance we assessed the patients’ quality of life using the with
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