Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events.
Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events.
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DOI：
10.1056/nejmoa0906431
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发表时间：
2009-10-01
影响因子：
158.5
通讯作者：
Zareba, Wojciech
中科院分区：
文献类型：
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作者：
Moss, Arthur J.;Hall, W. Jackson;Zareba, Wojciech
背景：本试验旨在确定心脏再同步化治疗（CRT）与双心室起搏是否会降低轻度心脏症状、射血分数降低和宽QRS复合体患者的死亡或心力衰竭事件的风险。方法：在4.5年的时间里，我们招募并随访了1820例缺血性或非缺血性心肌病患者，这些患者的射血分数为30%或更低，QRS持续时间为130毫秒或更长，并且有纽约心脏协会I级或II级症状。患者按3:2的比例随机分配，接受CRT +植入式心律转复除颤器（ICD）（1089例）或单独使用ICD（731例）。主要终点是任何原因导致的死亡或非致命性心力衰竭事件（以先发生者为准）。心衰事件由知道治疗任务的医生诊断，但由不知道任务的委员会裁决。结果：在平均2.4年的随访期间，1089例CRT-ICD组患者中有187例（17.2%）出现主要终点，731例仅icd组患者中有185例（25.3%）出现主要终点（CRT-ICD组的风险比为0.66；95%可信区间[CI]， 0.52 ~ 0.84； P=0.001）。缺血性心肌病患者和非缺血性心肌病患者的获益无显著差异。CRT的优势在于心脏衰竭事件的风险降低了41%，这一发现主要在QRS持续时间为150毫秒或更长时间的预先指定的亚组患者中得到了证明。CRT与左心室容量的显著减少和射血分数的改善有关。两组之间的总体死亡风险没有显著差异，每个治疗组的年死亡率为3%。两组患者均未发生严重不良事件。结论：CRT联合ICD降低了相对无症状的低射血分数和宽QRS复合物患者心衰事件的风险。（ClinicalTrials.gov编号：NCT00180271）中华医学杂志，2009;31(1):329- 338。
Background: This trial was designed to determine whether cardiac-resynchronization therapy (CRT) with biventricular pacing would reduce the risk of death or heart-failure events in patients with mild cardiac symptoms, a reduced ejection fraction, and a wide QRS complex.Methods: During a 4.5-year period, we enrolled and followed 1820 patients with ischemic or nonischemic cardiomyopathy, an ejection fraction of 30% or less, a QRS duration of 130 msec or more, and New York Heart Association class I or II symptoms. Patients were randomly assigned in a 3:2 ratio to receive CRT plus an implantable cardioverter-defibrillator (ICD) (1089 patients) or an ICD alone (731 patients). The primary end point was death from any cause or a nonfatal heart-failure event (whichever came first). Heart-failure events were diagnosed by physicians who were aware of the treatment assignments, but they were adjudicated by a committee that was unaware of assignments.Results: During an average follow-up of 2.4 years, the primary end point occurred in 187 of 1089 patients in the CRT-ICD group (17.2%) and 185 of 731 patients in the ICD-only group (25.3%) (hazard ratio in the CRT-ICD group, 0.66; 95% confidence interval [CI], 0.52 to 0.84; P=0.001). The benefit did not differ significantly between patients with ischemic cardiomyopathy and those with nonischemic cardiomyopathy. The superiority of CRT was driven by a 41% reduction in the risk of heart-failure events, a finding that was evident primarily in a prespecified subgroup of patients with a QRS duration of 150 msec or more. CRT was associated with a significant reduction in left ventricular volumes and improvement in the ejection fraction. There was no significant difference between the two groups in the overall risk of death, with a 3% annual mortality rate in each treatment group. Serious adverse events were infrequent in the two groups.Conclusions: CRT combined with ICD decreased the risk of heart-failure events in relatively asymptomatic patients with a low ejection fraction and wide QRS complex. (ClinicalTrials.gov number, NCT00180271.)N Engl J Med 2009;361:1329-38.