FFRCT Analysis technology, from HeartFlow, could lower the cost of evaluating patients with suspected coronary artery disease by as much as 32%, when compared to invasive coronary angiography. New data reveals the potential to use the technology to improve patient quality of life. These data were presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) meeting, and published in the Journal of the American College of Cardiology.
The findings were part of the multicentre, controlled, prospective PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) trial, which included more than 580 patients. The study compared the FFRCT Analysis to standard diagnostic strategies. The HeartFlow Analysis is the only non-invasive technology which can offer physicians insight into both the extent of a patient’s arterial blockage and its impact on blood flow.
Previous studies have shown the need to improve the accuracy of non-invasive tests used to evaluate coronary artery disease. A recent study, which included data from more than 1,100 U.S. hospitals, found that 55% of the more than 385,000 patients with stable chest pain who underwent an invasive coronary angiogram had no obstructive coronary disease.
“Non-invasive coronary angiography with cardiac CT is very sensitive in detecting anatomic abnormalities, but does not evaluate whether the lesion seen by CT is actually impeding coronary blood flow,” says lead investigator Mark A. Hlatky, Stanford University School of Medicine. “Our study suggests that the information about the effects of lesions on blood flow that is provided by FFRCT could reduce the use of invasive coronary angiography, and thereby reduce costs, in patients who otherwise would have been scheduled for invasive procedures.”
In the PLATFORM trial, patients were divided into one of two groups – those with a planned invasive test and those with a planned non-invasive 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. Cumulative medical costs for all patients were measured over 90 days using the 2015 Medicare reimbursement rates and online pharmacy costs as the standard in order to provide an accurate cost comparison.
In patients with a planned invasive test, the 90-day, per-patient cost of medical care was 32% lower in the FFRCT-guided strategy than in the usual care strategy (US$7,343 vs. US$10,734, p<0.0001). The savings did not account for the cost of FFRCT because Medicare has not set a reimbursement rate for the technology. However, the authors concluded that use of FFRCT guided evaluation could be cost saving compared with invasive testing under most likely levels of reimbursement for FFRCT. For example, they calculated that if reimbursement for the HeartFlow Analysis were US$2,100, use of the test would still save the healthcare system 20% over an invasive usual care strategy.
In addition to the cost savings, FFRCT showed greater improvement in quality of life at 90-day follow-up, as compared to baseline, than evaluation with usual non-invasive testing.
“We developed FFRCT with the goal of not only improving clinical care and patient outcomes, but also driving down costs by helping to ensure that invasive procedures were reserved only for the patients who needed them,” said John H. Stevens, chairman and CEO of HeartFlow.
The health economics and quality of life data follow initial PLATFORM study results were presented at the European Society of Cardiology in September and simultaneously published in the European Heart Journal. The first set of data focused on the clinical impact of FFRCT.
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. It received CE mark in 2011 and FDA clearance in November 2014.