PLATFORM Results Support HeartFlow FFRCT Analysis for Assessing CAD
April 12, 2016—HeartFlow, Inc. recently announced the presentation of data demonstrating that the company’s technology significantly reduces the need for invasive procedures to diagnose patients suspected of having coronary artery disease (CAD). Additionally, it leads to a sustained reduction in the cost of care. The 1-year data of the HeartFlow Fractional Flow Reserve Computed Tomography (FFRCT) Analysis were presented at ACC.16, the American College of Cardiology’s 65th Annual Scientific Session held April 2–4 in Chicago, Illinois.
HeartFlow FFRCT Analysis is a noninvasive technology that provides physicians insight into both the extent of a patient’s arterial blockage and the functional impact the blockage has on blood flow.
According to the company, the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) trial compared standard diagnostic strategies to a HeartFlow-guided strategy.
PLATFORM is a multicenter, controlled, prospective, pragmatic, comparative effectiveness trial utilizing a consecutive cohort design. It included 584 patients with stable chest pain at 11 centers across Europe. The observational study evaluated the effectiveness of usual care testing, which was decided by the site, to testing utilizing coronary CT angiography (cCTA) and, when necessary, FFRCT. Patients were divided into 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 received the FFRCT-guided strategy. Enrollment was completed in November 2014.
In the study, the HeartFlow-guided strategy resulted in the cancellation of a planned invasive coronary angiogram (ICA) in 60% of patients. After 1 year, none of the 117 patients who had an ICA cancelled had experienced an adverse clinical event. Furthermore, the data showed that use of a HeartFlow-guided strategy resulted in savings to the health care system of 33% after 1 year, as compared to patients who received standard care.
The released 1-year results showed that in patients who were in the planned invasive test group the mean 1-year per-patient cost for FFRCT-guided strategy was $8,127 versus $12,145 for usual care strategy (P < .0001), not accounting for the cost of the FFRCT test.
The PLATFORM study’s lead investigator is Pamela Douglas, MD, the Ursula Geller Professor at the Duke Clinical Research Institute at the Duke University School of Medicine in Durham, North Carolina.
In the company’s press release, Dr. Douglas commented, “The 1-year data affirms use of the HeartFlow Analysis can in many patients safely eliminate the need for invasive catheterizations, and markedly reduce cost of care in patients with suspected coronary artery disease. This represents a significant advance in the diagnosis and treatment of patients with stable chest pain, who previously may have been sent for unnecessary invasive testing to determine appropriate treatment pathways.”
The company noted that studies have shown the need to improve the accuracy of noninvasive tests used to evaluate CAD. According to a recent study that included data from more than 1,100 hospitals in the United States, 55% of the more than 385,000 patients with suspected CAD who underwent an ICA had no obstructive coronary disease. In the PLATFORM trial, a HeartFlow-guided strategy reduced the rate of normal or near-normal ICA by more than 80%.
The HeartFlow FFRCT Analysis is a web-based platform that aids clinicians in diagnosing CAD, and provides personalized, actionable information to physicians to manage each patient. FFRCT technology solves millions of complex equations simulating blood flow in the coronary arteries to provide mathematically computed fractional flow reserve values from images derived from noninvasive cCTA. FFRCT values indicate blood pressure differences around a coronary narrowing to determine whether it is likely to reduce blood flow to the heart.
The HeartFlow FFRCT Analysis has been evaluated in four large, prospective clinical trials enrolling more than 1,100 patients at major medical centers worldwide. It received European CE Mark approval in 2011 and US Food and Drug Administration clearance in November 2014.