Lindenfeld JoAnn, Feldman Arthur M, Saxon Leslie, Boehmer John, Carson Peter, Ghali Jalal K, Anand Inder, Singh Steve, Steinberg Jonathan S, Jaski Brian, DeMarco Teresa, Mann David, Yong Patrick, Galle Elizabeth, Ecklund Fred, Bristow Michael
Department of Medicine, University of Colorado Health Sciences Center, 4200 E. Ninth Ave, Denver, CO 80262, USA.
Circulation. 2007 Jan 16;115(2):204-12. doi: 10.1161/CIRCULATIONAHA.106.629261. Epub 2006 Dec 26.
Cardiac resynchronization therapy (CRT) alone or combined with an implantable defibrillator (CRT-D) has been shown to improve exercise capacity and quality of life and to reduce heart failure (HF) hospitalizations and mortality in patients with New York Heart Association (NYHA) class III and IV HF. There is concern that the device procedure may destabilize these very ill class IV patients. We sought to examine the outcomes of NYHA class IV patients enrolled in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial to assess the potential benefits of CRT and CRT-D.
The COMPANION trial randomized 1520 patients with NYHA class III and IV HF to optimal medical therapy, CRT, or CRT-D. In the class IV patients (n=217), the primary end point of time to death or hospitalization for any cause was significantly improved by both CRT (hazard ratio [HR], 0.64; 95% CI, 0.43 to 0.94; P=0.02) and CRT-D (HR, 0.62; 95% CI, 0.42 to 0.90; P=0.01). Time to all-cause death and HF hospitalization was also significantly improved in both CRT (HR, 0.57; 95% CI, 0.37 to 0.87; P=0.01) and CRT-D (HR, 0.49; 95% CI, 0.32 to 0.75; P=0.001) Time to all-cause death trended to an improvement in both CRT (HR, 0.67; 95% CI, 0.41 to 1.10; P=0.11) and CRT-D (HR, 0.63; 95% CI, 0.39 to 1.03; P=0.06). Time to sudden death appeared to be significantly reduced in the CRT-D group (HR, 0.27; 95% CI, 0.08 to 0.90; P=0.03). There was a nonsignificant reduction in time to HF deaths for both CRT (HR, 0.68; 95% CI, 0.34 to 1.37; P=0.28) and CRT-D (HR, 0.79; 95% CI, 0.41 to 1.52; P=0.48).
CRT and CRT-D significantly improve time to all-cause mortality and hospitalizations in NYHA class IV patients, with a trend for improved mortality. These devices should be considered in ambulatory NYHA class IV HF patients similar to those enrolled in COMPANION.
心脏再同步治疗（CRT）单独使用或与植入式心脏除颤器（CRT-D）联合使用，已被证明可改善纽约心脏协会（NYHA）III级和IV级心力衰竭（HF）患者的运动能力和生活质量，并减少HF住院率和死亡率。有人担心该设备操作可能会使这些病情非常严重的IV级患者病情不稳定。我们试图研究参与心力衰竭的药物治疗、起搏和除颤比较（COMPANION）试验的NYHA IV级患者的结局，以评估CRT和CRT-D的潜在益处。
COMPANION试验将1520例NYHA III级和IV级HF患者随机分为最佳药物治疗组、CRT组或CRT-D组。在IV级患者（n = 217）中，CRT（风险比[HR]，0.64；95%可信区间[CI]，0.43至0.94；P = 0.02）和CRT-D（HR，0.62；95% CI，0.42至0.90；P = 0.01）均显著改善了任何原因导致的死亡或住院时间这一主要终点。CRT组（HR，0.57；95% CI，0.37至0.87；P = 0.01）和CRT-D组（HR，0.49；95% CI，0.32至0.75；P = 0.001）的全因死亡和HF住院时间也显著改善。CRT组（HR，0.67；95% CI，0.41至1.10；P = 0.11）和CRT-D组（HR，0.63；95% CI，0.39至1.03；P = 0.06）的全因死亡时间均有改善趋势。CRT-D组的猝死时间似乎显著缩短（HR，0.27；95% CI，0.08至0.90；P = 0.03）。CRT组（HR，0.68；95% CI，0.34至1.37；P = 0.28）和CRT-D组（HR，0.79；95% CI，0.41至1.52；P = 0.48）的HF死亡时间均有非显著缩短。
CRT和CRT-D显著改善NYHA IV级患者的全因死亡率和住院时间，死亡率有改善趋势。对于与参与COMPANION试验的患者类似的非卧床NYHA IV级HF患者，应考虑使用这些设备。
