Long-term comparison of the implantable cardioverter defibrillator versus amiodarone - Eleven-year follow-up of a subset of patients in the Canadian Implantable Defibrillator Study (CIDS)
Long-term comparison of the implantable cardioverter defibrillator versus amiodarone - Eleven-year follow-up of a subset of patients in the Canadian Implantable Defibrillator Study (CIDS)
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DOI：
10.1161/01.cir.0000134957.51747.6e
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发表时间：
2004-07-13
期刊：
影响因子：
37.8
通讯作者：
Dorian, P
中科院分区：
文献类型：
--
作者：
Bokhari, F;Newman, D;Dorian, P
背景-植入型心律转复除颤器(ICD)在心脏性猝死的二级预防中优于胺碘酮。然而，这种益处在长期随访中的幅度尚不清楚。因此，我们的目标是评估胺碘酮和ICD作为一线单一治疗对既往有持续性室性心动过速/室颤或心脏骤停病史的患者的长期后果。方法和结果：共有120名患者在圣迈克尔医院加拿大植入式除颤器研究(CIDS)中登记，并被随机分配接受胺碘酮(n=60)或ICD(n=60)。治疗策略在CIDS结束后没有改变，除非最初分配的治疗无效或与严重副作用有关。平均随访5.6+/-2.6年，胺碘酮组死亡28例(47%)，ICD组死亡16例(27%)(P=0.0213)。胺碘酮组的总死亡率为每年5.5%，而ICD组为每年2.8%(胺碘酮的危险比：ICD，2.011；95%可信区间，1.087-3.721；P=0.0261)。在胺碘酮组中，49名患者(占所有患者的82%)出现了与胺碘酮相关的副作用，其中30名患者(占所有患者的50%)需要停药或减少剂量；19名患者因胺碘酮失效(n=7)或副作用(n=12)而改用ICD。结论：在CIDs的一个亚组中，ICD的益处随着时间的推移而增加；大多数接受胺碘酮治疗的患者最终会出现副作用、心律失常复发或死亡。
Background-The implantable cardioverter defibrillator (ICD) is superior to amiodarone for secondary prophylaxis of sudden cardiac death. However, the magnitude of this benefit over long-term follow-up is not known. Thus, our objective was to evaluate the long-term consequences of using amiodarone versus an ICD as first-line monotherapy in patients with a prior history of sustained ventricular tachycardia/ventricular fibrillation or cardiac arrest.Methods and Results-A total of 120 patients were enrolled at St Michael's Hospital in the Canadian Implantable Defibrillator Study (CIDS) and were randomly assigned to receive either amiodarone (n = 60) or an ICD (n = 60). The treatment strategy was not altered after the end of CIDS unless the initial assigned therapy was not effective or was associated with serious side effects. After a mean follow-up of 5.6 +/- 2.6 years, there were 28 deaths (47%) in the amiodarone group, compared with 16 deaths (27%) in the ICD group (P = 0.0213). Total mortality was 5.5% per year in the amiodarone group versus 2.8% per year in the ICD group ( hazard ratio of amiodarone: ICD, 2.011; 95% confidence interval, 1.087 to 3.721; P = 0.0261). In the amiodarone group, 49 patients (82% of all patients) had side effects related to amiodarone, of which 30 patients (50% of all patients) required discontinuation or dose reduction; 19 patients crossed over to ICD because of amiodarone failure (n = 7) or side effects (n = 12).Conclusions-In a subset of CIDS, the benefit of the ICD over amiodarone increases with time; most amiodarone-treated patients eventually develop side effects, have arrhythmia recurrences, or die.