Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio, USA.
J Cardiovasc Electrophysiol. 2012 Dec;23(12):1317-25. doi: 10.1111/j.1540-8167.2012.02402.x. Epub 2012 Jul 25.
Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population. This trial was designed to evaluate the effect of atrial support pacing among heart failure patients receiving a CRT defibrillator.
PEGASUS CRT was a multicenter, 3-arm, randomized study. At 6 weeks, patients were randomized to DDD mode at a lower rate of 40 bpm (DDD-40; control arm), or one of the following 2 treatment arms: DDD-70, or DDDR-40. The primary endpoint was a clinical composite endpoint that included all-cause mortality, heart failure events, NYHA functional class, and patient global self-assessment. Subjects were classified as improved, unchanged, or worsened at 12 months. There were 1,433 patients randomized, of whom 66% were male, mean age was 67 ± 11 years, and mean left ventricular ejection fraction was 23 ± 7%. The average follow-up time was 10.5 ± 3.5 months and 1,309 patients contributed to the primary endpoint. No significant differences were observed in the composite endpoint between either of the 2 treatment arms compared to the control arm (P>0.05 for both comparisons). Additionally, there were no differences among the groups in mortality or heart failure events.
In advanced heart failure patients treated with CRT, atrial support pacing did not improve clinical outcomes compared to atrial tracking. However, atrial pacing did not adversely affect mortality or heart failure events.
迄今为止,心脏再同步治疗 (CRT) 疗效试验使用的是心房同步双心室起搏,其中没有或只有最小的心房起搏。然而,在这一患者群体中,心动过缓和变时功能不全很常见。本试验旨在评估心力衰竭患者接受 CRT 除颤器治疗时心房支持起搏的效果。
PEGASUS CRT 是一项多中心、三臂、随机研究。在 6 周时,患者随机分为 40 次/分的 DDD 模式(DDD-40;对照组),或以下 2 种治疗组之一:DDD-70 或 DDDR-40。主要终点是包括全因死亡率、心力衰竭事件、NYHA 功能分级和患者整体自我评估的临床综合终点。在 12 个月时,患者被分类为改善、不变或恶化。共有 1433 例患者随机分组,其中 66%为男性,平均年龄为 67±11 岁,平均左心室射血分数为 23±7%。平均随访时间为 10.5±3.5 个月,共有 1309 例患者纳入主要终点。与对照组相比,在这两种治疗组之间,复合终点均无显著差异(两种比较的 P>0.05)。此外,各组之间的死亡率或心力衰竭事件无差异。
在接受 CRT 治疗的晚期心力衰竭患者中,与心房跟踪相比,心房支持起搏并不能改善临床结局。然而,心房起搏并没有对死亡率或心力衰竭事件产生不利影响。