Primary prevention of sudden cardiac death in idiopathic dilated cardiomyopathy -: The cardiomyopathy trial (CAT)
Primary prevention of sudden cardiac death in idiopathic dilated cardiomyopathy -: The cardiomyopathy trial (CAT)
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DOI：
10.1161/01.cir.0000012350.99718.ad
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发表时间：
2002-03-26
期刊：
影响因子：
37.8
通讯作者：
Kuck, KH
中科院分区：
文献类型：
--
作者：
Bänsch, D;Antz, M;Kuck, KH
背景-患有特发性扩张型心肌病（DCM）和左心室射血分数受损的患者突然死亡的风险增加。方法和结果-近期发病的DCM（小于或等于9个月）且射血分数小于或等于30%的患者被随机分配至植入式心脏复律除颤器（ICD）组或对照组。该试验的主要终点是随访一年时的全因死亡率。该试验在纳入 104 名患者后终止，因为对照组 1 年全因死亡率未达到预期的 30%。 2000年8月，通过联系患者、亲属或当地登记处更新了所有患者的生命状况。 104 名患者参加了该试验：50 名患者被分配至 ICD 治疗组，54 名患者被分配至对照组。根据研究人员的随访，平均随访时间为 22.8 +/- 4.3 个月。 1年后，6名患者死亡（ICD组4名，对照组2名）。随访第一年和第二年均未发生猝死。 2000 年 8 月，平均随访 5.5 +/- 2.2 年后，出现 30 例死亡（ICD 组 13 例，对照组 17 例）。两组之间的累积生存率没有显着差异（2 年后和 4 年后，对照组为 93% 和 80%，ICD 组分别为 92% 和 86%）。 结论——该试验没有提供支持对近期发病且左心室射血分数受损的 DCM 患者进行预防性 ICD 植入的证据。
Background-Patients with idiopathic dilated cardiomyopathy (DCM) and impaired left ventricular ejection fraction have an increased risk of dying suddenly.Methods and Results-Patients with recent onset of DCM (less than or equal to9 months) and an ejection fraction less than or equal to30% were randomly assigned to the implantation of an implantable cardioverter-defibrillator (ICD) or control. The primary end point of the trial was all-cause mortality at 1 year of follow-up. The trial was terminated after the inclusion of 104 patients because the all-cause mortality rate at 1 year did not reach the expected 30% in the control group. In August 2000, the vital status of all patients was updated by contacting patients, relatives, or local registration offices. One hundred four patients were enrolled in the trial: Fifty were assigned to ICD therapy and 54 to the control group. Mean follow-up was 22.8 +/- 4.3 months, on the basis of investigators' follow-up. After 1 year, 6 patients were dead (4 in the ICD group and 2 in the control group). No sudden death occurred during the first and second years of follow-up. In August 2000, after a mean follow-up of 5.5 +/- 2.2 years, 30 deaths had occurred (13 in the ICD group and 17 in the control group). Cumulative survival was not significantly different between the two groups (93% and 80% in the control group versus 92% and 86% in the ICD group after 2 and 4 years, respectively).Conclusions-This trial did not provide evidence in favor of prophylactic ICD implantation in patients with DCM of recent onset and impaired left ventricular ejection fraction.