Why the study?
Non-ischemic HF patients have a more favorable response to de novo CRT, but the efficacy of CRT upgrade by HF etiology needed assessment.
Does CRT-D upgrade reduce the composite of HF hospitalization, mortality, or lack of reverse remodeling in HFrEF patients with prior PM/ICD and high RV pacing burden compared to ICD?
RCT (n=360)
Randomized
Does CRT-D upgrade reduce the composite of HF hospitalization, mortality, or lack of reverse remodeling in HFrEF patients with prior PM/ICD and high RV pacing burden compared to ICD?
Effect estimate: aOR 0.11 (ischemic), aOR 0.12 (non-ischemic) (95% CI 0.05-0.23 (ischemic), 0.05-0.28 (non-ischemic))
p-value: p=<0.001
CRT-D upgrade significantly reduces the composite of mortality, HF hospitalization, or lack of reverse remodeling in HFrEF patients with high RV pacing burden, regardless of whether the etiology is ischemic or non-ischemic.
Background Non-ischemic HF patients are known to have a more favorable response to de novo cardiac resynchronization therapy (CRT). Purpose We aimed to assess the efficacy of CRT upgrade in the BUDAPEST-CRT Upgrade trial population by heart failure (HF) etiology. Methods Heart Failure patients with reduced ejection fraction (HFrEF) and priorly implanted pacemaker (PM) or implantable cardioverter defibrillator (ICD) and 20% right ventricular (RV) pacing burden were randomized to CRT-D upgrade (n=215) or ICD (n=145). Primary- [HF hospitalization (HFH), all-cause mortality, or <15% reduction of left ventricular end-systolic volume] and secondary outcomes were investigated by ischemic etiology defined as prior infarction or coronary intervention. Results At enrolment 209 (58%) had ischemic etiology, of whose risk to the primary endpoint [adjusted odds ratio (aOR) 1.78; 95%CI 1.02-3.11; p=0.042], however they did not show a higher risk for all-cause mortality or HFH (aOR 0.84; 95%CI 0.47-1.48; p=0.54) during the mean follow-up time of 12.4 months. Having ischemic etiology decreased the odds of showing echocardiographic response (aOR 0.53; 95%CI 0.29-0.95; p=0.034). Despite these results, the effect of CRT-D upgrade on the primary endpoint was similar in patient with ischemic and non-ischemic etiology (ischemic aOR 0.11; 95%CI 0.05-0.23; p‹0.001; non-ischemic aOR 0.12; 95%CI 0.05-0.28; p‹0.001; interaction p=0.91). Also CRT-D upgrade improved the echocardiographic response with a heterogeneous treatment effect (ischemic adjusted left ventricular end-diastolic volume difference -25.24mL, 95%CI -40.32 to -10.17, p=0.001; non-ischemic -55.79ml, 95%CI -77.96 to -33.62, p‹0.001; interaction p=0.013). Conclusion In HFrEF patients and PM/ICD with high RV pacing burden, CRT-D upgrade decreased the risk of the primary endpoint regardless of the etiology. CRT-D upgrade showed a significant but less favorable echocardiographic response in ischemic HF patients.
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Kis et al. (2026) conducted an RCT in Heart Failure with reduced ejection fraction (HFrEF) (n=360). CRT-D upgrade vs. ICD was evaluated on HF hospitalization (HFH), all-cause mortality, or <15% reduction of left ventricular end-systolic volume (aOR 0.11 (ischemic), aOR 0.12 (non-ischemic), 95% CI 0.05-0.23 (ischemic), 0.05-0.28 (non-ischemic), p=<0.001).
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