US-based medical device company V-Wave released primary data from the RELIEVE-HF pivotal trial of its Ventura interatrial shunt.
The randomised RELIEVE-HF trial (NCT03499236) failed to meet its primary endpoint by showing neither shunt-related benefit nor harm. The study did meet the primary safety endpoint, with no major adverse cardiovascular or neurological events (MACNE) occurring during the first 30 days and no such events to 24 months.
The data was presented at the American College of Cardiology (ACC) Annual Scientific Session & Expo in Atlanta taking place from 6 to 8 April.
The RELIEVE-HF trial enrolled 508 patients with advanced heart failure (HF) and any left ventricular ejection fraction (LVEF) who were at high risk for cardiovascular morbidity and mortality events. The participants received either an interatrial shunt device or a control placebo procedure. The participants were also stratified into two groups - reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF), with each assigned equally to shunt or control treatment.
V-Wave was quick to add that the “directionally opposite effects in the HFrEF vs. HFpEF patients” were responsible for the study missing its primary endpoint.
The group analysis found that shunt implantation in HFrEF patients was associated with a 45% decrease in cardiovascular events. Furthermore, shunt implantation in HFpEF patients was associated with an increase in adverse cardiovascular events.
"The RELIEVE-HF data are groundbreaking for the field of heart failure. Although the primary endpoint was not met, the study showed impressive results with interatrial shunting in patients with HFrEF but also definitively showed that this is not the right treatment for those who had HFpEF in our study," said Dr Gregg W Stone, one of the principal trial investigators.
The Ventura interatrial shunt is a minimally invasive, catheter-implanted investigational device designed to relieve increased LAP, and in turn, decrease fluid build-up in the lungs. It comprises biocompatible expanded polytetrafluoroethylene (ePTFE) encapsulation, which is designed to limit tissue growth and allow the shunt to remain open and unobstructed.
The shunt was granted breakthrough device designation by the US Food and Drug Administration (FDA) and a CE mark in the EU.
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