A Marc Gillinov1, Emilia Bagiella1, Alan J Moskowitz1, Jesse M Raiten1, Mark A Groh1, Michael E Bowdish1, Gorav Ailawadi1, Katherine A Kirkwood1, Louis P Perrault1, Michael K Parides1, Robert L Smith1, John A Kern1, Gladys Dussault1, Amy E Hackmann1, Neal O Jeffries1, Marissa A Miller1, Wendy C Taddei-Peters1, Eric A Rose1, Richard D Weisel1, Deborah L Williams1, Ralph F Mangusan1, Michael Argenziano1, Ellen G Moquete1, Karen L O'Sullivan1, Michel Pellerin1, Kinjal J Shah1, James S Gammie1, Mary Lou Mayer1, Pierre Voisine1, Annetine C Gelijns1, Patrick T O'Gara1, Michael J Mack1. 1. From the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland (A.M.G.); the International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (E.B., A.J.M., K.A.K., M.K.P., D.L.W., E.G.M., K.L.O., K.J.S., A.C.G.), Department of Cardiac Surgery, Mount Sinai Health System (E.A.R.), and Division of Cardiothoracic Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University (M.A.) - all in New York; Department of Anesthesiology and Critical Care, University of Pennsylvania (J.M.R.), and Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine (M.L.M.) - both in Philadelphia; Cardiovascular and Thoracic Surgery, Mission Health and Hospitals, Asheville, NC (M.A.G., R.F.M.); Department of Surgery, Keck School of Medicine of USC, University of Southern California, Los Angeles (M.E.B., A.E.H.); Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville (G.A., J.A.K.); Montreal Heart Institute, Université de Montréal, Montreal (L.P.P., M.P.), Institut Universitaire de Cardiologie et de Pneumologie de Québec, Hôpital Laval, Quebec, QC (G.D., P.V.), and Peter Munk Cardiac Centre and Division of Cardiovascular Surgery, Toronto General Hospital, University Health Network and the Division of Cardiac Surgery, University of Toronto, Toronto (R.D.W.) - all in Canada; Department of Cardiovascular Surgery, Heart Hospital Baylor Plano, Baylor Health Care System, Plano, TX (R.L.S., M.J.M.); Office of Biostatistics Research (N.O.J.) and Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute, Bethesda, and Department of Surgery, University of Maryland Medical Center, Baltimore (J.S.G.) - both in Maryland; and the Cardiovascular Division, Brigham and Women's Hospital, Boston (P.T.O.).
Abstract
BACKGROUND: Atrial fibrillation after cardiac surgery is associated with increased rates of death, complications, and hospitalizations. In patients with postoperative atrial fibrillation who are in stable condition, the best initial treatment strategy--heart-rate control or rhythm control--remains controversial. METHODS:Patients with new-onset postoperative atrial fibrillation were randomly assigned to undergo either rate control or rhythm control. The primary end point was the total number of days of hospitalization within 60 days after randomization, as assessed by the Wilcoxon rank-sum test. RESULTS:Postoperative atrial fibrillation occurred in 695 of the 2109 patients (33.0%) who were enrolled preoperatively; of these patients, 523 underwent randomization. The total numbers of hospital days in the rate-control group and the rhythm-control group were similar (median, 5.1 days and 5.0 days, respectively; P=0.76). There were no significant between-group differences in the rates of death (P=0.64) or overall serious adverse events (24.8 per 100 patient-months in the rate-control group and 26.4 per 100 patient-months in the rhythm-control group, P=0.61), including thromboembolic and bleeding events. About 25% of the patients in each group deviated from the assigned therapy, mainly because of drug ineffectiveness (in the rate-control group) or amiodarone side effects or adverse drug reactions (in the rhythm-control group). At 60 days, 93.8% of the patients in the rate-control group and 97.9% of those in the rhythm-control group had had a stable heart rhythm without atrial fibrillation for the previous 30 days (P=0.02), and 84.2% and 86.9%, respectively, had been free from atrial fibrillation from discharge to 60 days (P=0.41). CONCLUSIONS: Strategies for rate control and rhythm control to treat postoperative atrial fibrillation were associated with equal numbers of days of hospitalization, similar complication rates, and similarly low rates of persistent atrial fibrillation 60 days after onset. Neither treatment strategy showed a net clinical advantage over the other. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT02132767.).
RCT Entities:
BACKGROUND:Atrial fibrillation after cardiac surgery is associated with increased rates of death, complications, and hospitalizations. In patients with postoperative atrial fibrillation who are in stable condition, the best initial treatment strategy--heart-rate control or rhythm control--remains controversial. METHODS:Patients with new-onset postoperative atrial fibrillation were randomly assigned to undergo either rate control or rhythm control. The primary end point was the total number of days of hospitalization within 60 days after randomization, as assessed by the Wilcoxon rank-sum test. RESULTS:Postoperative atrial fibrillation occurred in 695 of the 2109 patients (33.0%) who were enrolled preoperatively; of these patients, 523 underwent randomization. The total numbers of hospital days in the rate-control group and the rhythm-control group were similar (median, 5.1 days and 5.0 days, respectively; P=0.76). There were no significant between-group differences in the rates of death (P=0.64) or overall serious adverse events (24.8 per 100 patient-months in the rate-control group and 26.4 per 100 patient-months in the rhythm-control group, P=0.61), including thromboembolic and bleeding events. About 25% of the patients in each group deviated from the assigned therapy, mainly because of drug ineffectiveness (in the rate-control group) or amiodarone side effects or adverse drug reactions (in the rhythm-control group). At 60 days, 93.8% of the patients in the rate-control group and 97.9% of those in the rhythm-control group had had a stable heart rhythm without atrial fibrillation for the previous 30 days (P=0.02), and 84.2% and 86.9%, respectively, had been free from atrial fibrillation from discharge to 60 days (P=0.41). CONCLUSIONS: Strategies for rate control and rhythm control to treat postoperative atrial fibrillation were associated with equal numbers of days of hospitalization, similar complication rates, and similarly low rates of persistent atrial fibrillation 60 days after onset. Neither treatment strategy showed a net clinical advantage over the other. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT02132767.).
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