Amiodarone to Prevent Recurrence of Atrial Fibrillation
Denis Roy, M.D., Mario Talajic, M.D., Paul Dorian, M.D., Stuart Connolly, M.D., Mark J. Eisenberg, M.D., M.P.H., Martin Green, M.D., Teresa Kus, M.D., Jean Lambert, Ph.D., Marc Dubuc, M.D., Pierre Gagné, M.D., Stanley Nattel, M.D., Bernard Thibault, M.D., for The Canadian Trial of Atrial Fibrillation Investigators
Background The restoration and maintenance of sinus rhythm isa desirable goal in patients with atrial fibrillation, becausethe prevention of recurrences can improve cardiac function andrelieve symptoms. Uncontrolled studies have suggested that amiodaronein low doses may be more effective and safer than other agentsin preventing recurrence, but this agent has not been testedin a large, randomized trial.
Methods We undertook a prospective, multicenter trial to testthe hypothesis that low doses of amiodarone would be more efficaciousin preventing recurrent atrial fibrillation than therapy withsotalol or propafenone. We randomly assigned patients who hadhad at least one episode of atrial fibrillation within the previoussix months to amiodarone or to sotalol or propafenone, givenin an open-label fashion. The patients in the group assignedto sotalol or propafenone underwent a second randomization todetermine whether they would receive sotalol or propafenonefirst; if the first drug was unsuccessful the second agent wasprescribed. Loading doses of the drugs were administered andelectrical cardioversion was performed (if necessary) within21 days after randomization for all patients in both groups.The follow-up period began 21 days after randomization. Theprimary end point was the length of time to a first recurrenceof atrial fibrillation.
Results Of the 403 patients in the study, 201 were assignedto amiodarone and 202 to either sotalol (101 patients) or propafenone(101 patients). After a mean of 16 months of follow-up, 71 ofthe patients who were assigned to amiodarone (35 percent) and127 of those who were assigned to sotalol or propafenone (63percent) had a recurrence of atrial fibrillation (P<0.001).Adverse events requiring the discontinuation of drug therapyoccurred in 18 percent of the patients receiving amiodarone,as compared with 11 percent of those treated with sotalol orpropafenone (P=0.06).
Conclusions Amiodarone is more effective than sotalol or propafenonefor the prevention of recurrences of atrial fibrillation.
Source Information
From the Montreal Heart Institute, Montreal (D.R., M.T., M.J.E., J.L., M.D., P.G., S.N., B.T.); St. Michael's Hospital, Toronto (P.D.); Hamilton General Hospital and McMaster University, Hamilton, Ont. (S.C.); the University of Ottawa Heart Institute, Ottawa, Ont. (M.G.); and Hôpital du Sacré-Cur de Montréal, Montreal (T.K.) all in Canada.
Address reprint requests to Dr. Roy at the Montreal Heart Institute, 5000 Belanger St. E., Montreal, QC H1T 1C8, Canada, or at roy{at}icm.umontreal.ca.
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