Island Medical Program, University of British Columbia, Vancouver, Canada.
N Engl J Med. 2010 Dec 16;363(25):2385-95. doi: 10.1056/NEJMoa1009540. Epub 2010 Nov 14.
Cardiac-resynchronization therapy (CRT) benefits patients with left ventricular systolic dysfunction and a wide QRS complex. Most of these patients are candidates for an implantable cardioverter-defibrillator (ICD). We evaluated whether adding CRT to an ICD and optimal medical therapy might reduce mortality and morbidity among such patients.
We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 msec or more or a paced QRS duration of 200 msec or more to receive either an ICD alone or an ICD plus CRT. The primary outcome was death from any cause or hospitalization for heart failure.
We followed 1798 patients for a mean of 40 months. The primary outcome occurred in 297 of 894 patients (33.2%) in the ICD-CRT group and 364 of 904 patients (40.3%) in the ICD group (hazard ratio in the ICD-CRT group, 0.75; 95% confidence interval [CI], 0.64 to 0.87; P<0.001). In the ICD-CRT group, 186 patients died, as compared with 236 in the ICD group (hazard ratio, 0.75; 95% CI, 0.62 to 0.91; P = 0.003), and 174 patients were hospitalized for heart failure, as compared with 236 in the ICD group (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). However, at 30 days after device implantation, adverse events had occurred in 124 patients in the ICD-CRT group, as compared with 58 in the ICD group (P<0.001).
Among patients with NYHA class II or III heart failure, a wide QRS complex, and left ventricular systolic dysfunction, the addition of CRT to an ICD reduced rates of death and hospitalization for heart failure. This improvement was accompanied by more adverse events. (Funded by the Canadian Institutes of Health Research and Medtronic of Canada; ClinicalTrials.gov number, NCT00251251.).
心脏再同步治疗（CRT）可使左心室收缩功能障碍和宽 QRS 复合物的患者受益。这些患者大多数是植入式心脏复律除颤器（ICD）的候选者。我们评估了在 ICD 和最佳药物治疗的基础上增加 CRT 是否可以降低此类患者的死亡率和发病率。
我们随机分配纽约心脏协会（NYHA）心功能 II 或 III 级、左心室射血分数 30%或更低、固有 QRS 持续时间 120 毫秒或更长或起搏 QRS 持续时间 200 毫秒或更长的患者接受 ICD 单独治疗或 ICD 加 CRT。主要结局是任何原因导致的死亡或心力衰竭住院。
我们对 1798 名患者进行了平均 40 个月的随访。在 ICD-CRT 组的 894 名患者中，有 297 名（33.2%）发生主要结局，在 ICD 组的 904 名患者中，有 364 名（40.3%）发生主要结局（ICD-CRT 组的危险比为 0.75；95%置信区间[CI]为 0.64 至 0.87；P<0.001）。在 ICD-CRT 组中，有 186 名患者死亡，而 ICD 组有 236 名患者死亡（危险比，0.75；95%CI，0.62 至 0.91；P=0.003），174 名患者因心力衰竭住院，而 ICD 组有 236 名患者住院（危险比，0.68；95%CI，0.56 至 0.83；P<0.001）。然而，在 ICD-CRT 组中，有 124 名患者在装置植入后 30 天发生不良事件，而 ICD 组中有 58 名患者发生不良事件（P<0.001）。
在 NYHA 心功能 II 或 III 级、宽 QRS 复合物和左心室收缩功能障碍的患者中，在 ICD 上增加 CRT 可降低死亡率和心力衰竭住院率。这种改善伴随着更多的不良事件。（由加拿大卫生研究院和加拿大美敦力公司资助；ClinicalTrials.gov 编号，NCT00251251）。
