心力衰竭伴 QRS 波群<120 毫秒患者的心脏再同步治疗：心力衰竭再同步治疗评估（LESSER-EARTH）试验。
Cardiac resynchronization therapy in patients with heart failure and a QRS complex <120 milliseconds: the Evaluation of Resynchronization Therapy for Heart Failure (LESSER-EARTH) trial.
机构信息
Montreal Heart Institute, Université de Montréal, Montreal, QB, Canada.
出版信息
Circulation. 2013 Feb 26;127(8):873-81. doi: 10.1161/CIRCULATIONAHA.112.001239. Epub 2013 Feb 6.
BACKGROUND
Although the benefits of cardiac resynchronization therapy are well established in selected patients with heart failure and a prolonged QRS duration, salutary effects in patients with narrow QRS complexes remain to be demonstrated.
METHODS AND RESULTS
The Evaluation of Resynchronization Therapy for Heart Failure (LESSER-EARTH) trial is a randomized, double-blind, 12-center study that was designed to compare the effects of active and inactive cardiac resynchronization therapy in patients with severe left ventricular dysfunction and a QRS duration <120 milliseconds. The trial was interrupted prematurely by the Data Safety and Monitoring Board because of futility and safety concerns after 85 patients were randomized. Changes in exercise duration after 12 months were no different in patients with and without active cardiac resynchronization therapy (-0.7 minutes [95% confidence interval (CI), -2.9 to 1.5] versus 0.8 minutes [95% CI, -1.2 to 2.9]; P=0.31]. Similarly, no significant differences were observed in left ventricular end-systolic volumes (-6.4 mL [95% CI, -18.8 to 5.9] versus 3.1 mL [95% CI, -9.2 to 15.5]; P=0.28) and ejection fraction (3.3% [95% CI, 0.7-6.0] versus 2.1% [95% CI, -0.5 to 4.8]; P=0.52). Moreover, cardiac resynchronization therapy was associated with a significant reduction in the 6-minute walk distance (-11.3 m [95% CI, -31.7 to 9.7] versus 25.3 m [95% CI, 6.1-44.5]; P=0.01), an increase in QRS duration (40.2 milliseconds [95% CI, 34.2-46.2] versus 3.4 milliseconds [95% CI, 0.6-6.2]; P<0.0001), and a nonsignificant trend toward an increase in heart failure-related hospitalizations (15 hospitalizations in 5 patients versus 4 hospitalizations in 4 patients).
CONCLUSIONS
In patients with a left ventricular ejection fraction ≤35%, symptoms of heart failure, and a QRS duration <120 milliseconds, cardiac resynchronization therapy did not improve clinical outcomes or left ventricular remodeling and was associated with potential harm.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00900549.
背景
尽管心脏再同步治疗在伴有 QRS 时限延长的心力衰竭患者中已被证实具有良好的疗效，但在 QRS 时限较窄的患者中的有益作用仍有待证实。
方法和结果
心力衰竭心脏再同步治疗评估（LESSER-EARTH）试验是一项随机、双盲、12 中心研究，旨在比较活性和非活性心脏再同步治疗对严重左心室功能障碍和 QRS 时限<120 毫秒的患者的影响。由于无效性和安全性问题，该试验在 85 名患者随机分组后，被数据安全和监测委员会提前中断。在 12 个月时，接受和未接受活性心脏再同步治疗的患者的运动时间无明显差异（-0.7 分钟[95%置信区间（CI），-2.9 至 1.5]与 0.8 分钟[95% CI，-1.2 至 2.9]；P=0.31]）。同样，左心室收缩末期容积也无显著差异（-6.4 毫升[95% CI，-18.8 至 5.9]与 3.1 毫升[95% CI，-9.2 至 15.5]；P=0.28）和射血分数（3.3%[95% CI，0.7-6.0]与 2.1%[95% CI，-0.5 至 4.8]；P=0.52）。此外，心脏再同步治疗与 6 分钟步行距离显著减少（-11.3 米[95% CI，-31.7 至 9.7]与 25.3 米[95% CI，6.1-44.5]；P=0.01）、QRS 时限延长（40.2 毫秒[95% CI，34.2-46.2]与 3.4 毫秒[95% CI，0.6-6.2]；P<0.0001）和心力衰竭相关住院治疗呈增加趋势（5 例患者中有 15 例住院治疗，4 例患者中有 4 例住院治疗）。
结论
在左心室射血分数≤35%、心力衰竭症状和 QRS 时限<120 毫秒的患者中，心脏再同步治疗并未改善临床结局或左心室重构，且可能存在潜在危害。
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