Department of Medicine, Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Statistical Data Analysis Center, Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin, USA.
JACC Heart Fail. 2021 Jun;9(6):439-449. doi: 10.1016/j.jchf.2021.02.013. Epub 2021 May 12.
The aim of this study was to determine whether patients with heart failure with reduced ejection fraction (HFrEF) due to nonischemic etiology eligible for cardiac resynchronization therapy (CRT) benefit from an implantable cardioverter-defibrillator (ICD).
It is uncertain whether CRT with an ICD (CRT-D) compared to without an ICD (CRT-P) is associated with a survival benefit in patients with nonischemic etiologies of HFrEF.
Analyses of the COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure) trial were performed, using Cox proportional hazards modeling stratified by HFrEF etiology of nonischemic cardiomyopathy (NICM) or ischemic cardiomyopathy (ICM). The primary outcome was all-cause mortality (ACM), and secondary outcomes were the combination of cardiovascular mortality or heart failure hospitalization and sudden cardiac death.
Among patients randomized to CRT (n = 1,212), 236 (19.5%) died, 131 and 105 in the CRT-P and CRT-D arms, respectively. The unadjusted and adjusted hazard ratios (HRs) for CRT-D versus CRT-P were both 0.84 (95% confidence interval [CI]: 0.65 to 1.09) for ACM, with a significant device-etiology interaction (p = 0.015 adjusted; p = 0.040 unadjusted). In patients with NICM (n = 555), CRT-D versus CRT-P was associated with reduced ACM (adjusted HR: 0.54; 95% CI: 0.34 to 0.86), while patients with ICM (n = 657) did not exhibit a between-device reduction in ACM (adjusted HR: 1.05; 95% CI: 0.77 to 1.44). The effects of CRT-D versus CRT-P on sudden cardiac death (advantage CRT-D) and cardiovascular mortality or heart failure hospitalization (no difference between CRT-P and CRT-D) were similar between the 2 HFrEF etiologies.
COMPANION patients with NICM exhibited a decrease in ACM associated with CRT-D but not CRT-P treatment, whereas patients with ICM did not.
本研究旨在确定是否因非缺血性病因导致射血分数降低的心力衰竭（HFrEF）且符合心脏再同步治疗（CRT）适应证的患者能从植入式心脏复律除颤器（ICD）中获益。
对于非缺血性 HFrEF 患者，与 ICD 相比，CRT （CRT-D）是否与生存获益相关尚不确定。
对 COMPANION（心力衰竭的药物治疗、起搏和除颤比较）试验进行分析，采用 Cox 比例风险模型，按非缺血性心肌病（NICM）或缺血性心肌病（ICM）的 HFrEF 病因分层。主要结局为全因死亡率（ACM），次要结局为心血管死亡率或心力衰竭住院和心源性猝死的联合终点。
在随机接受 CRT 的患者中（n=1212），236 例（19.5%）死亡，CRT-P 组和 CRT-D 组分别为 131 例和 105 例。未调整和调整后的 CRT-D 与 CRT-P 的 HR 均为 0.84（95%置信区间[CI]：0.65 至 1.09），设备病因交互作用有统计学意义（p=0.015 调整后；p=0.040 未调整）。在 NICM 患者（n=555）中，与 CRT-P 相比，CRT-D 降低了 ACM（调整 HR：0.54；95%CI：0.34 至 0.86），而 ICM 患者（n=657）中，ACM 并未因器械治疗而降低（调整 HR：1.05；95%CI：0.77 至 1.44）。CRT-D 与 CRT-P 对心源性猝死（CRT-D 获益）和心血管死亡率或心力衰竭住院（CRT-P 和 CRT-D 之间无差异）的影响在两种 HFrEF 病因之间相似。
COMPANION 中，NICM 患者的 ACM 下降与 CRT-D 相关，但与 CRT-P 无关，而 ICM 患者则不然。
