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.).
N Engl J Med. 2016 Jul 14;375(2):111-21. doi: 10.1056/NEJMoa1513614. Epub 2016 May 5.
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.
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.
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.
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.).
尽管采用了抗心律失常药物治疗,植入式心脏复律除颤器(ICD)的心肌梗死后幸存者仍经常出现复发性室性心动过速。管理这一问题的最有效方法尚不确定。
我们进行了一项多中心、随机、对照试验,纳入了患有缺血性心肌病和 ICD 的患者,这些患者尽管使用了抗心律失常药物仍患有室性心动过速。患者被随机分配接受导管消融(消融组)或抗心律失常药物升级治疗(升级治疗组)。在升级治疗组中,如果之前使用了其他药物,则开始使用胺碘酮。如果每日剂量小于 300mg,则增加胺碘酮的剂量;如果每日剂量已经至少 300mg,则加用美西律。主要终点是死亡、24 小时内 3 次或更多次记录的室性心动过速(室速风暴)或合适的 ICD 电击的复合终点。
在纳入的 259 例患者中,132 例被分配至消融组,127 例被分配至升级治疗组。在平均(±SD)27.9±17.1 个月的随访期间,消融组中 59.1%的患者和升级治疗组中 68.5%的患者发生了主要终点事件(消融组的风险比为 0.72;95%置信区间为 0.53 至 0.98;P=0.04)。两组之间的死亡率无显著差异。消融组有 2 例心脏穿孔和 3 例大出血,升级治疗组有 2 例死于肺毒性和 1 例死于肝功能障碍。
在抗心律失常药物治疗后仍有室性心动过速的缺血性心肌病和 ICD 患者中,与接受抗心律失常药物升级治疗的患者相比,导管消融患者的死亡、室速风暴或合适的 ICD 电击的复合主要终点事件发生率显著降低。(由加拿大卫生研究院和其他机构资助;VANISH 临床试验.gov 编号,NCT00905853。)