First patients enrolled in clinical trial aimed at limiting unnecessary ICAs
HeartFlow, a California-based health technology company focused on cardiac care, announced that physicians at Erasmus MC Hospital in the Netherlands have enrolled the first three patients for the FUSION randomized controlled trial.
The trial, funded by the National Health Care Institute of the Netherlands, is designed to assess whether the use of the HeartFlow FFRCT Analysis as part of a coronary diagnostic pathway is helpful in reducing unnecessary invasive coronary angiograms (ICAs). The trial is on track to enroll 528 patients from six Dutch hospitals.
Patients with a computed tomography angiogram (CTA) that indicates coronary artery disease (CAD) will be randomized between the HeartFlow FFRCT arm or the ICA arm. The trial's primary endpoint will be the rate of unnecessary ICAs. An ICA is seen as unnecessary if there is no obstructive coronary stenosis, defined as an anatomical narrowing >50% or invasive FFR ≤0.80.
According to HeartFlow, the degree to which a narrowing of an artery causes chest pain cannot always be determined by a CTA. As a result, many patients undergo an ICA who do not need one.
“By combining the functional information provided by HeartFlow FFRCT with the anatomical information from the coronary CTA, we will be better able to assess non-invasively which patients require further invasive investigation,” Ricardo Budde, MD, PhD, associate professor and principal investigator of cardiovascular Imaging at Erasmus MC Hospital, said in a press release. “With the FUSION trial, we anticipate a 33% reduction in unnecessary ICAs which we believe will lead to cost savings for the overall healthcare system.”
“Both in clinical trials and real-world clinical practice, we have seen that the use of the HeartFlow Analysis in a coronary diagnostic pathway delivers a significant reduction in invasive angiograms which are in retrospect unnecessary,” added Campbell Rogers, MD, chief medical officer for HeartFlow. “We anticipate the FUSION trial will deliver similar outcomes to our previous studies and look forward to working with the National Health Care Institute to make the HeartFlow Analysis available to patients in the Netherlands in the near future.”