Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms
试验设计:左室功能异常(NYHA心功能分级Ⅰ–Ⅱ级)且宽QRS的患者随机分为心脏再同步化治疗(CRT)组(n= 419)和最佳药物治疗组(n= 191)。
结果
● 病情恶化:CRT组16%,最佳药物治疗组21%(P=0.1)。
● 左室收缩末期容积指数:CRT组下降18.4 ml/m2,最佳药物治疗组下降1.3 ml/m2(P<0.0001)。
● CRT组心力衰竭住院风险降低(P=0.03)。
结论
● CRT不能延缓轻度心力衰竭患者病情进展。
● 与药物治疗相比,CRT改善左室收缩末期容积指数,降低再住院率。
原始摘要:
Objectives: We sought to determine the effects of cardiac resynchronization therapy (CRT) in New York Heart Association (NYHA) functional class II heart failure (HF) and NYHA functional class I (American College of Cardiology/American Heart Association stage C) patients with previous HF symptoms.
Background: Cardiac resynchronization therapy improves left ventricular (LV) structure and function and clinical outcomes in NYHA functional class III and IV HF with prolonged QRS.
Methods: Six hundred ten patients with NYHA functional class I or II heart failure with a QRS 120 ms and a LV ejection fraction 40% received a CRT device (±defibrillator) and were randomly assigned to active CRT (CRT-ON; n = 419) or control (CRT-OFF; n = 191) for 12 months. The primary end point was the HF clinical composite response, which scores patients as improved, unchanged, or worsened. The prospectively powered secondary end point was LV end-systolic volume index. Hospitalization for worsening HF was evaluated in a prospective secondary analysis of health care use.
Results: The HF clinical composite response end point, which compared only the percent worsened, indicated 16% worsened in CRT-ON compared with 21% in CRT-OFF (p = 0.10). Patients assigned to CRT-ON experienced a greater improvement in LV end-systolic volume index (–18.4 ± 29.5 ml/m2 vs. –1.3 ± 23.4 ml/m2, p < 0.0001) and other measures of LV remodeling. Time-to-first HF hospitalization was significantly delayed in CRT-ON (hazard ratio: 0.47, p = 0.03).
Conclusions: The REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) trial demonstrates that CRT, in combination with optimal medical therapy (±defibrillator), reduces the risk for heart failure hospitalization and improves ventricular structure and function in NYHA functional class II and NYHA functional class I (American College of Cardiology/American Heart Association stage C) patients with previous HF symptoms.