Key result
Cardiac-resynchronization therapy did not reduce death or heart failure hospitalization compared to control (28.7% vs 25.2%; HR 1.20; 95% CI 0.92-1.57; P=0.15) and may increase mortality.
Why the study?
Does cardiac-resynchronization therapy reduce death or heart failure hospitalization in patients with systolic heart failure, a narrow QRS complex (<130 msec), and echocardiographic evidence of left ventricular dyssynchrony?
RCT (n=809)
randomly assigned
Yes
Does cardiac-resynchronization therapy reduce death or heart failure hospitalization in patients with systolic heart failure, a narrow QRS complex (<130 msec), and echocardiographic evidence of left ventricular dyssynchrony?
Hazard Ratio: 1.2 (95% CI 0.92–1.57)
Absolute Event Rate: 28.7% vs 25.2%
p-value: p=0.15
In patients with systolic heart failure and a narrow QRS complex (<130 msec), CRT does not improve clinical outcomes and may increase mortality, demonstrating futility and potential harm in this population.
CRT should be avoided in narrow-QRS systolic HF due to futility and possible harm; challenges extension of CRT beyond wide QRS.
Background Cardiac-resynchronization therapy (CRT) reduces morbidity and mortality in chronic systolic heart failure with a wide QRS complex. Mechanical dyssynchrony also occurs in patients with a narrow QRS complex, which suggests the potential usefulness of CRT in such patients. Methods We conducted a randomized trial involving 115 centers to evaluate the effect of CRT in patients with New York Heart Association class III or IV heart failure, a left ventricular ejection fraction of 35% or less, a QRS duration of less than 130 msec, and echocardiographic evidence of left ventricular dyssynchrony. All patients underwent device implantation and were randomly assigned to have CRT capability turned on or off. The primary efficacy outcome was the composite of death from any cause or first hospitalization for worsening heart failure. Results On March 13, 2013, the study was stopped for futility on the recommendation of the data and safety monitoring board. At study closure, the 809 patients who had undergone randomization had been followed for a mean of 19.4 months. The primary outcome occurred in 116 of 404 patients in the CRT group, as compared with 102 of 405 in the control group (28.7% vs. 25.2%; hazard ratio, 1.20; 95% confidence interval [CI], 0.92 to 1.57; P=0.15). There were 45 deaths in the CRT group and 26 in the control group (11.1% vs. 6.4%; hazard ratio, 1.81; 95% CI, 1.11 to 2.93; P=0.02). Conclusions In patients with systolic heart failure and a QRS duration of less than 130 msec, CRT does not reduce the rate of death or hospitalization for heart failure and may increase mortality. (Funded by Biotronik and GE Healthcare; EchoCRT ClinicalTrials.gov number, NCT00683696 .).
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A 2014 study conducted an RCT in systolic heart failure with a narrow QRS complex (n=809). Cardiac-resynchronization therapy (CRT) vs. CRT capability turned off was evaluated on composite of death from any cause or first hospitalization for worsening heart failure (HR 1.20, 95% CI 0.92 to 1.57, p=0.15). Cardiac-resynchronization therapy did not reduce death or heart failure hospitalization compared to control (28.7% vs 25.2%; HR 1.20; 95% CI 0.92-1.57; P=0.15) and may increase mortality.
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