PLATFORM Findings Presented for HeartFlow's FFRCT Analysis

September 1, 2015—HeartFlow, Inc. announced findings from the PLATFORM (Prospective Longitudinal Trial of Fractional Flow Reserve Computed Tomography [FFRCT]: Outcome and Resource Impacts) study showing that HeartFlow FFRCT analysis significantly reduced the use of invasive catheterization in patients with suspected coronary artery disease compared to the use of standard diagnostic strategies. The HeartFlow FFRCT analysis is designed to provide insight into both the extent of a patient’s arterial blockage and the impact the blockage has on blood flow.

The study was presented in a Hot Line session at the European Society of Cardiology’s ESC Congress 2015 held August 29 to September 2 in London, United Kingdom. The PLATFORM study was simultaneously published online ahead of print by Principal Investigator Pamela S. Douglas, MD, et al in the European Heart Journal. Dr. Douglas is the Ursula Geller Professor at the Duke Clinical Research Institute, Duke University School of Medicine in Durham, North Carolina.

PLATFORM is a multicenter, controlled, prospective, pragmatic, comparative effectiveness trial utilizing a consecutive cohort design. The trial is composed of 584 patients with stable chest pain enrolled at 11 centers across Europe. Enrollment was completed in November 2014.

The observational study evaluated the effectiveness of usual care testing, which was decided by the site, to testing the utilization of coronary CT angiography  and, when necessary, FFRCT. Patients were divided into one of two groups: those with a planned invasive test and those with a planned noninvasive test. Patients in each group were then enrolled into one of two sequential cohorts: those who followed the usual diagnostic path and those who underwent the FFRCT-guided strategy.

The current results reflect all patients being followed for a minimum of 90 days. Subsequent follow-up to 1 year is ongoing.

According to HeartFlow, the PLATFORM findings demonstrated that among patients with planned invasive coronary angiography (ICA), 73% had an ICA that showed no significant blockage or obstruction. By comparison, only 12% of patients evaluated using an FFRCT-guided strategy went on to have an ICA that showed no significant obstruction, a reduction of 83%. In 61% of patients, the use of an FFRCT-guided strategy resulted in the cancellation of a planned invasive test.

Despite the difference in the number of patients who required ICA, the rate of revascularization procedures (eg, coronary stenting or bypass surgery) were similar between patients assigned to standard testing strategies (31.6%) and those assigned to FFRCT-guided strategies (28.5%). No clinical adverse events were reported at the 90-day follow-up in patients whose physicians chose to cancel ICAs based on FFRCT-guided strategy, advised HeartFlow.

Dr. Douglas commented in the company’s press release, “The study demonstrated that by using FFRCT, physicians were able to efficiently triage patients to the most appropriate care and dramatically reduce the use of invasive testing, which comes with greater risk and higher costs. While FFRCT is a relatively new technology, this study shows that physicians and patients being evaluated for stable chest pain should consider including this new test in the course of standard diagnostics.”

The company noted that FFRCT technology solves millions of complex equations simulating blood flow in the coronary arteries to provide mathematically computed FFR values from images derived from noninvasive coronary CT angiography. The HeartFlow FFRCT analysis has been evaluated in four large, prospective clinical trials enrolling a total of more than 1,100 patients at major medical centers worldwide.

The HeartFlow FFRCT analysis received European CE Mark approval in 2011 and US Food and Drug Administration clearance in November 2014.