February 1, 2016
View Full PaperRelation of QRS Duration to Clinical Benefit of Cardiac Resynchronization Therapy in Mild Heart Failure Patients Without Left Bundle Branch Block
Key Result
In patients with mild heart failure without left bundle branch block, CRT-D did not significantly reduce the risk of HF hospitalization or death compared to ICD alone at 7 years (56% vs 45%, P=0.209).
Study Design
Type
RCT (n=537)
Randomization
randomized
Multicenter
Yes
Structured PICO
Does CRT-D reduce heart failure hospitalization or death in patients with mild heart failure without left bundle branch block compared to ICD only?
P
Population
537 non-left bundle branch block patients with mild heart failure followed for 7 years.
I
Intervention
Cardiac resynchronization therapy with defibrillator (CRT-D)
C
Comparator
Implantable cardioverter-defibrillator (ICD) only therapy
O
Outcome
Composite of heart failure hospitalization or death at 7 years of follow-upcomposite
CRT-D does not provide long-term clinical benefit in mild heart failure patients without LBBB, and may increase the risk of adverse outcomes in those with a relatively shorter QRS duration (≤ 134 ms).
Main Result
Absolute Event Rate: 56% vs 45%
p-value: p=0.209
Abstract
BACKGROUND: There are conflicting data regarding the efficacy of cardiac resynchronization therapy (CRT) in patients with heart failure (HF) and without left bundle branch block. METHODS AND RESULTS: We evaluated the long-term clinical outcomes of 537 non-left bundle branch block patients with mild HF enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study by QRS duration or morphology further stratified by PR interval. At 7 years of follow-up, the cumulative probability of HF hospitalization or death was 45% versus 56% among patients randomized to implantable cardioverter-defibrillator and CRT with defibrillator (CRT-D), respectively (P=0.209). Multivariable-adjusted subgroup analysis by QRS duration showed that patients from the lower quartile QRS duration group (≤ 134 ms) experienced 2.4-fold (P=0.015) increased risk for HF hospitalization or death with CRT-D versus implantable cardioverter-defibrillator only therapy, whereas the effect of CRT-D in patients from the upper quartiles group (QRS>134 ms) was neutral (hazard ratio HR =0.97, P=0.86; P value for interaction =0.024). In a second analysis incorporating PR interval, patients with prolonged QRS (>134 ms) and prolonged PR (>230 ms) were protected with CRT-D (HR=0.31, P=0.003), whereas the association was neutral with prolonged QRS (>134 ms) and shorter PR (≤ 230 ms;, HR=1.19, P=0.386; P value for interaction =0.002). The effect was neutral, regardless of morphology, right bundle branch block (HR=1.01, P=0.975), and intraventricular conduction delay (HR=1.31, P=0.172). CONCLUSIONS: Overall, patients with mild HF but without left bundle branch block morphology did not derive clinical benefit with CRT-D during long-term follow-up. Relatively shorter QRS was associated with a significantly increased risk with CRT-D relative to implantable cardioverter-defibrillator -only. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00180271, NCT01294449, and NCT02060110.