HeartFlow presented data from a clinical trial of its FFRct analysis that showed a significant reduction in unnecessary invasive coronary angiography after evaluation with the device. The data was presented at European Society of Cardiology’s annual meeting in London today.
HeartFlow’s FFRct platform is an imaging approach that helps physicians treat coronary artery disease by getting a detailed look at the extent of blockage and blood flow. The technology allows the company to approach a problem cardiologists have been struggling with for a long time, CEO John Stevens told MassDevice.com in an interview.
“This is what we’ve really focused on in the last 5 and a half years. The clinical question that cardiologists ask tens of millions of times every year around the world – ‘does my patient have coronary artery disease, yes or no, and if so, what do I do about it?’ And that is a remarkably hard question to answer,” Stevens said.
Data from the study of the company’s device showed that it is helping physicians get closer to answering that question.
The 580-patient multi-center prospective Platform trial reported that among patients who had a planned ICA, 73% showed no significant blockage or obstruction.
To compare, only 12% of patients who were evaluated with HeartWare’s FFRct platform who went on to have an ICA procedure found no blockage or obstruction. In 61% of patients, the FFRct test resulted in the cancellation of a planned invasive test, according to the study.
Despite that difference, both ICA only and FFRct evaluated patients had similar rates of revascularization at 31.6% and 28.5%, respectively.
But the reduction in unnecessary invasive procedures is important, Stevens said, as more procedures inherently raises the rate of adverse events and other related issues.
“In the current state of affairs, the way we are practicing in the U.S. today, the number of patients going to the cath lab that don’t have any obstructive disease is well over 50%,” Stevens said.
The technology, and its ability to help avoid unnecessary interventions, could be the 1st signs of a fundamental shift in how coronary artery diseases is managed, Stevens said.
“I think this was a real world demonstration of, I think, how practice might change in the coming years. So, you see the patient’s quality of life we want to see, the economic benefits we want to see, and finally there wasn’t a single adverse event,” Stevens said.
Stevens said the report wasn’t all the data, however, with economic and quality of life data to be presented at a late-breaking clinical trial at the Transcatheter Cardiovascular Therapeutics meeting in October.