HeartFlow’s FFRct Analysis Will Be Studied in FUSION Trial to Reduce Unnecessary ICA

September 2, 2021—HeartFlow, Inc. announced that physicians at Erasmus MC Hospital in Rotterdam, the Netherlands, have enrolled the first three patients in the FUSION randomized controlled trial.

FUSION is evaluating the addition of the HeartFlow fractional flow reserve CT (FFRct) in the diagnostic pathway of patients with stable chest pain to reduce unnecessary invasive coronary angiography (ICA). The trial is supported by the National Health Care Institute of the Netherlands.

The company noted that in the Netherlands 180,000 patients annually visit a cardiologist with complaints of chest pain. These patients typically receive a coronary CTA to determine if there is stenosis or narrowing in the coronary artery. Because the degree to which a narrowing is causing chest pain is not always clear from a coronary CTA alone, patients are often sent for an ICA. More than half of patients who undergo an ICA are found to have no coronary disease or only nonobstructive disease, making the ICA unnecessary in retrospect, noted the company.

According to the company, the FUSION trial is planned to enroll 528 patients from six Dutch hospitals. Patients whose CTA shows coronary artery disease will be randomized between the HeartFlow FFRct arm or the ICA arm.

The primary endpoint is the rate of unnecessary ICAs as reflected by ICAs without obstructive coronary stenosis defined as an anatomical narrowing > 50% or invasive FFR ≤ 0.80. Once the trial is complete, it is anticipated that the data will support insurance reimbursement in the Netherlands for the HeartFlow analysis.

“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,” commented Ricardo Budde, MD, in the company’s 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.” Dr. Budde is Associate Professor and Principal Investigator of Cardiovascular Imaging at Erasmus MC Hospital.

“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,” commented HeartFlow’s Chief Medical Officer, Campbell Rogers, MD, in the company’s press release. “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.”

The HeartFlow FFRct analysis is commercially available in the United States, United Kingdom, Canada, Europe, and Japan, advised the company.