John L Sapp1, George A Wells1, Ratika Parkash1, William G Stevenson1, Louis Blier1, Jean-Francois Sarrazin1, Bernard Thibault1, Lena Rivard1, Lorne Gula1, Peter Leong-Sit1, Vidal Essebag1, Pablo B Nery1, Stanley K Tung1, Jean-Marc Raymond1, Laurence D Sterns1, George D Veenhuyzen1, Jeff S Healey1, Damian Redfearn1, Jean-Francois Roux1, Anthony S L Tang1. 1. From the Department of Medicine, QEII Health Sciences Centre and Dalhousie University, Halifax, NS (J.L.S., R.P.), University of Ottawa Heart Institute, Ottawa (G.A.W., P.B.N.), Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (L.B., J.-F.S.), Institut de Cardiologie de Montréal (B.T., L.R.), McGill University Health Center and Hôpital Sacré-Coeur de Montréal (V.E.), and Centre Hospitalier de L'Universite de Montréal (J.-M.R.), Montreal, Western University, London, ON (L.G., P.L.-S., A.S.L.T.), the Division of Cardiology, Royal Columbian Hospital, New Westminster, BC (S.K.T.), Royal Jubilee Hospital, Victoria, BC (L.D.S.), Libin Cardiovascular Institute of Alberta, Calgary (G.D.V.), Population Health Research Institute, Hamilton, ON (J.S.H.), Kingston General Hospital, Kingston, ON (D.R.), and Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC (J.-F.R.) - all in Canada; and the Cardiovascular Division, Brigham and Women's Hospital, Boston (W.G.S.).
Abstract
BACKGROUND: Recurrent ventricular tachycardia among survivors of myocardial infarction with an implantable cardioverter-defibrillator (ICD) is frequent despite antiarrhythmic drug therapy. The most effective approach to management of this problem is uncertain. METHODS: We conducted a multicenter, randomized, controlled trial involving patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite the use of antiarrhythmic drugs. Patients were randomly assigned to receive either catheter ablation (ablation group) with continuation of baseline antiarrhythmic medications or escalated antiarrhythmic drug therapy (escalated-therapy group). In the escalated-therapy group, amiodarone was initiated if another agent had been used previously. The dose of amiodarone was increased if it had been less than 300 mg per day or mexiletine was added if the dose was already at least 300 mg per day. The primary outcome was a composite of death, three or more documented episodes of ventricular tachycardia within 24 hours (ventricular tachycardia storm), or appropriate ICD shock. RESULTS: Of the 259 patients who were enrolled, 132 were assigned to the ablation group and 127 to the escalated-therapy group. During a mean (±SD) of 27.9±17.1 months of follow-up, the primary outcome occurred in 59.1% of patients in the ablation group and 68.5% of those in the escalated-therapy group (hazard ratio in the ablation group, 0.72; 95% confidence interval, 0.53 to 0.98; P=0.04). There was no significant between-group difference in mortality. There were two cardiac perforations and three cases of major bleeding in the ablation group and two deaths from pulmonary toxic effects and one from hepatic dysfunction in the escalated-therapy group. CONCLUSIONS: In patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite antiarrhythmic drug therapy, there was a significantly lower rate of the composite primary outcome of death, ventricular tachycardia storm, or appropriate ICD shock among patients undergoing catheter ablation than among those receiving an escalation in antiarrhythmic drug therapy. (Funded by the Canadian Institutes of Health Research and others; VANISH ClinicalTrials.gov number, NCT00905853.).
RCT Entities:
BACKGROUND: Recurrent ventricular tachycardia among survivors of myocardial infarction with an implantable cardioverter-defibrillator (ICD) is frequent despite antiarrhythmic drug therapy. The most effective approach to management of this problem is uncertain. METHODS: We conducted a multicenter, randomized, controlled trial involving patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite the use of antiarrhythmic drugs. Patients were randomly assigned to receive either catheter ablation (ablation group) with continuation of baseline antiarrhythmic medications or escalated antiarrhythmic drug therapy (escalated-therapy group). In the escalated-therapy group, amiodarone was initiated if another agent had been used previously. The dose of amiodarone was increased if it had been less than 300 mg per day or mexiletine was added if the dose was already at least 300 mg per day. The primary outcome was a composite of death, three or more documented episodes of ventricular tachycardia within 24 hours (ventricular tachycardia storm), or appropriate ICD shock. RESULTS: Of the 259 patients who were enrolled, 132 were assigned to the ablation group and 127 to the escalated-therapy group. During a mean (±SD) of 27.9±17.1 months of follow-up, the primary outcome occurred in 59.1% of patients in the ablation group and 68.5% of those in the escalated-therapy group (hazard ratio in the ablation group, 0.72; 95% confidence interval, 0.53 to 0.98; P=0.04). There was no significant between-group difference in mortality. There were two cardiac perforations and three cases of major bleeding in the ablation group and two deaths from pulmonary toxic effects and one from hepatic dysfunction in the escalated-therapy group. CONCLUSIONS: In patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite antiarrhythmic drug therapy, there was a significantly lower rate of the composite primary outcome of death, ventricular tachycardia storm, or appropriate ICD shock among patients undergoing catheter ablation than among those receiving an escalation in antiarrhythmic drug therapy. (Funded by the Canadian Institutes of Health Research and others; VANISH ClinicalTrials.gov number, NCT00905853.).
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