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October 16, 2020

FORECAST Trial Investigates Cost and Clinical Advantage of FFR Derived From CT

October 16, 2020 –The use of fractional flow reserve management derived from computed tomography (FFRCT) did not significantly reduce costs but did reduce the use of invasive coronary angiography (ICA) in the FORECAST randomized clinical trial.

The primary endpoint of the FORECAST trial was resource utilization derived from noninvasive cardiac tests, invasive angiography, coronary revascularization, hospitalization for a cardiac event, and cardiac medications at 9 months. Prespecified secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE), revascularization, angina severity, and quality of life (QOL).

The findings were presented by Nick Curzen, BM (Hons), PhD, at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020. Dr. Curzen is Professor of Interventional Cardiology, University of Southampton, United Kingdom. The FORECAST trial was an investigator-initiated study with an unrestricted research grant from HeartFlow, Inc.

As noted in the TCT announcement, previous studies have indicated that FFRCT reduces the uptake of invasive angiography that shows no significant coronary artery disease, without compromising patient safety.

The clinical effectiveness and economic impact of using FFRCT instead of other tests in the evaluation of patients with stable chest pain has not yet been tested in a randomized trial, although based upon cost models on observational data, FFRCT is already recommended in routine clinical practice by National Institute for Health and Care Excellence (NICE) in the United Kingdom because it appeared cost dominant.

As summarized by TCT connect, the FORECAST trial was composed of 1,400 patients with stable chest pain at 11 centers in the United Kingdom. The patients were randomized to receive either coronary computed tomography angiography (CCTA) with FFRCT of lesions with stenosis severity of ≥ 40% (test arm, n = 699) or routine assessment as directed by the NICE Guideline for Chest Pain of Recent Onset (reference arm, n = 700).

The routine assessment arm included a mixture of noninvasive tests, including CCTA (without FFRCT) in 61.4% of subjects. The mean age of the overall population was 60 (25-89) years and 52% were male. Baseline demographics, angina status, and QOL/health status were similar between the groups.

The FORECAST investigators found that in patients presenting with new onset stable chest pain, a strategy of CTCA with FFRCT did not significantly reduce average total costs in the NHS system when compared with a strategy of routine care (£1,605.50 vs £1,491.46; P = .962).

At 9 months, the number of patients in the test arm who underwent the following noninvasive tests were: 674 for CTCA; 220 for FFRCT; 13 for stress echo; four for perfusion scan; 15 for stress MRI; and 27 for exercise ECG. The number of patients in the reference arm who underwent these tests were: 460 for CTCA; nine for FFRCT; 124 for stress echo; 34 for perfusion scan; 20 for stress MRI; and 99 for exercise ECG.

A total of 22% fewer patients in the test group had ICA compared to the reference group (136 vs 175; P = .01). There was no significant difference in the rates of MACCE or revascularization.

Dr. Curzen concluded in the TCT Connect press release, “Results from FORECAST indicate that CTCA and FFRCT as a frontline strategy may not be associated with the financial savings projected from observational data by NICE. However, the reduction in invasive coronary angiography is important and will be very attractive to patients. More data is needed to determine the optimal use for FFRCT in clinical practice.”

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