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RELIEVE-HF trial showed an interatrial shunt device implant in patients with LVEF less than or equal to 40% led to a CV event rate of 49% per year compared with 88.6% in the placebo group.

In the overall cohort of patients in the RELIEVE-HF trial with heart failure (HF) irrespective of reduced or preserved ejection fraction (EF), the implant of an inter-atrial shunt device did not lead to symptom reduction or prognosis improvement. However, the stratified results revealed a benefit for patients with HF and reduced EF but harm in those with preserved EF.

The multicentre, double-blind, sham-controlled RELIEVE-HF trial (NCT03499236) explored inter-atrial shunt treatment for patients with HF and either reduced or preserved EF.¹ The randomized 508 participants to receive a V-Wave® Ventura® shunt or a placebo procedure. To enable differentiation of results according to EF, researchers stratified randomization according to reduced (≤40%) and preserved EF (>40%).

The effectiveness up to 2 years was assessed by a hierarchical composite of all-cause death, heart transplant or left ventricular assist device (LVAD), recurrent HF hospitalizations, out-patient worsening HF events, and change in Kansas City Cardiomyopathy Questionnaire overall summary scores (KCCQ-OSS). The results on each level were reported in wins and losses for the trial arms.

RELIEVE-HF did not meet this primary endpoint as no significant difference was found for the win ratio between groups (P=0.2). Similar results were found for the risk of all cardiovascular (CV) events and KCCQ-OSS. “Where the results became particularly informative is when we looked at the stratified randomizations according to EF,” Gregg Stone, MD, highlighted.

In patients with LVEF less than or equal to 40%, the shunt led to a CV event rate of 49% per year compared with 88.6% in the placebo group (relative rate ratio 0.55; 95%CI 0.42–0.73; P<0.001). “In patients with preserved EF the exact opposite pattern was seen,” revealed Dr. Stone. Their control-arm event rate was 35.9%, while 60.2% in the shunt group (relative rate ratio 1.68; 95% CI 1.29–2.19; P<0.001). The risk of all CV events painted a similar picture of benefit and harm at stratification. Of note, the change in QOL did not differ between the strata, pointing to a relevant placebo effect in KCCQ-OSS outcomes.

Medical writing support was provided by Karin Drooff, MPH.
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