Cost and Quality of Life Outcomes from the PLATFORM Trial Reported at TCT 2015 and Published in JACC

SAN FRANCISCO – October 13, 2015 – New results from a multicenter, prospective study show that assessing fractional flow reserve estimated with computed tomography (FFRCT) may reduce costs in selected symptomatic patients with suspected coronary artery disease (CAD).

Cost and quality of life outcomes from the PLATFORM trial were reported today at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The study was also published in the Journal of the American College of Cardiology.

Fractional flow reserve (FFR) measures blood pressure and flow through a specific part of the coronary artery. It has typically been assessed using invasive catheter-based tests but can now be measured non-invasively using computed tomography data (FFRCT). The clinical effectiveness of using FFRCT to guide management, compared with conventional testing, was recently demonstrated in the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcomes and Resource Impacts) study. FFRCT was also recently approved for clinical use by the U.S. Food and Drug Administration and received a CE mark in Europe.

The purpose of this study was to assess the economic and quality of life outcomes of evaluation strategies that use FFRCT, based on data collected prospectively from the non-randomized PLATFORM study. 584 symptomatic patients with suspected CAD were enrolled at 11 European centers (204 in the planned non-invasive testing stratum and 380 in the planned invasive testing stratum). Within the planned non-invasive testing stratum, 100 patients were evaluated with the usual care strategy, and 104 patients were evaluated with the FFRCT strategy. In the planned invasive testing stratum, 187 patients were evaluated with the usual care strategy, and 193 patients were evaluated with the FFRCT strategy.

The number of diagnostic tests, invasive procedures, hospitalizations, and medications after 90 days were multiplied by U.S. cost weights and summed to derive total medical costs. Changes in quality of life (QOL) from baseline to 90 days were assessed using the Seattle Angina Questionnaire (SAQ), the EuroQOL (EQ-5D), and a visual analog scale (VAS).

In the 584 patients, 74% had atypical angina, and the pre-test probability of coronary disease was 49%. In the planned invasive stratum, mean costs were 32% lower among the FFRCT patients than among the usual care patients who typically underwent invasive coronary angiography ($7,343 vs. $10,734, p<0.0001). In the non-invasive stratum, mean costs were not significantly different between the FFRCT patients and the usual care patients who underwent traditional non-invasive risk stratification ($2,679 vs. $2,137, p=0.26).

In a sensitivity analysis, when the cost weight of FFRCT was set to seven times that of CTA, the FFRCT group still had lower costs than in the usual care group in the invasive testing stratum ($8,619 vs. $10,734, p < 0.0001) while in the noninvasive testing stratum, when the cost weight of FFRCT was set to half that of CTA, the FFRCT group had higher costs than the usual care group ($2,766 vs. $2,137, p=0.02).

Each quality of life (QOL) score improved in the overall study population (p<0.0001). In the noninvasive stratum, QOL scores improved more in FFRCT patients than in usual care patients: SAQ 19.5 vs. 11.4, p=0.003; EQ-5D 0.08 vs. 0.03, p=0.002; and VAS 4.1 vs 2.3, p=0.82. In the invasive cohort, the improvements in QOL were similar in the FFRCT and usual care patients.

“These results suggest that use of FFRCT might reduce overall costs and improve patient quality of life,” said lead researcher Mark Andrew Hlatky, MD. Dr. Hlatky is Professor of Health Research and Policy and of Medicine at the Stanford University School of Medicine in California.

“Larger, randomized studies are warranted to compare the clinical effectiveness of management strategies based on use of FFRCT with management strategies based on using other methods of anatomic or functional evaluation.”

The study was funded by HeartFlow, Inc. Dr. Hlatky reported research grants from HeartFlow, Inc.

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