For patients with chest pain and no known coronary artery disease, an evaluation strategy based on fractional flow reserve estimated using CT (FFRCT) led to reduced costs within 90 days and less resource utilization compared with an invasive coronary angiography evaluation strategy.
The quality of life and economic outcomes were based on data collected from the PLATFORM study, which previously showed the clinical effectiveness of (FFRCT) compared with conventional testing.
Lead author Mark A. Hlatky, MD, professor of health research and policy and medicine at Stanford University, presented the findings on Oct. 13 in a first report investigations clinical trial session at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.
Results were simultaneously published online in The Journal of the American College of Cardiology. HeartFlow, Inc., which developed FFRCT, supported the study with a grant.
In November, the FDA granted FFRCT de novo clearance. FFRCT is a noninvasive imaging technology that obtains functional data about coronary lesions from the CT scan.
The researchers noted the study was too small to evaluate the effect of FFRCT on major cardiac events. They also said a limitation was that it had an observational instead of a randomized design.
“The effect here is so big that I don’t think this was by chance,” Hlatky said. “I fully believe that that this would be best tested by doing a real, true, randomized study. I think it’s going to show the same thing, but I do think that the findings are quite interesting and completely in line with the clinical result. We’ve reduced a lot of invasive testing from doing this. That’s why it costs less.”
In the PLATFORM study, researchers enrolled 584 symptomatic patients with suspected coronary artery disease between Sept. 10, 2013, and Nov. 26, 2014, at 11 centers in Europe. Local clinicians chose to refer patients for noninvasive or invasive testing before the trial began.
In the planned noninvasive testing analysis, 100 patients received usual care and 106 were evaluated with the FFRCT strategy. In the planned invasive testing analysis, 187 patients received usual care and 193 were evaluated with the FFRCT strategy.
Hlatky said the researchers counted how many resources the patients utilized and used U.S. Medicare cost weights to calculate the costs over 90 days.
In the invasive analysis, the mean costs were $7,343 for the FFRCT group and $10,734 for the usual care group. In the noninvasive analysis, the mean costs were not significantly different: $2,679 for the FFRCT group and $2,137 for the usual care group.
The researchers also performed a sensitivity analysis during which they set the Medicare cost weight of FFRCT at seven times more than coronary CT angiography in the invasive testing analysis. In that scenario, the mean costs were $8,619 for the FFRCT group and $10,734 for the usual care group. When the Medicare cost weight of FFRCT was set at half that of coronary CT angiography in the noninvasive testing analysis, the mean costs were $2,766 for the FFRCT group and $2,137 for the usual care group.
“I think this combination of combining anatomy and physiology in evaluating patients with chest pain will be now a one-stop shop,” said Giora Weisz, MD, an associate professor of medicine at Columbia University Medical Center. “Patients with chest pain will be sent for a CT scan that will give us both the anatomy and the significance of the findings. There will be no need for any other noninvasive testing like any kind of stress test that we are doing now. It also showed its benefit for healthcare. It’s a win, win, win situation.”