Article Text
Abstract
Aim Diagnostic evaluation practices for suspected coronary artery disease (CAD) may vary between countries. Our objective was to compare a CT-derived fractional flow reserve (FFRCT) diagnostic strategy with usual care in patients with planned invasive coronary angiography (ICA) enrolled in the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) study at German sites.
Methods Patients were divided into two consecutive observational cohorts, receiving either usual care or CT angiography (CTA)/FFRCT. The primary endpoint was the percentage of patients planned for ICA, with no obstructive CAD on ICA within 90 days. Secondary endpoints included death, myocardial infarction, unstable angina, hospitalisation leading to unplanned revascularisation, cumulative radiation exposure, estimated medical costs and quality of life (QOL) at 1 year.
Results 116 patients were included. The primary endpoint occurred in 4 of the 52 patients (7.7%) in the CTA/FFRCT group and in 55 of the 64 patients (85.9%) in the usual care group (risk difference 78.2%, 95% CI 67.1% to 89.4%, p<0.001). ICA was cancelled in 40 of the 52 patients (77%) who underwent CTA/FFRCT. Clinical event rates were low overall. The mean radiation exposure was lower in the FFRCT versus the usual care group (7.28 vs 9.80 mSv, p<0.001). Mean estimated medical costs were €4217 (CTA/FFRCT) versus €6894 (usual care), p<0.001. Improvement in QOL (EQ-5D score) was greater in the FFRCT (+0.09 units) versus the usual care cohort (+0.03 units), p=0.04.
Conclusions In patients with suspected CAD planned for ICA at German sites, initial CTA/FFRCT compared with usual care was associated with a markedly reduced rate of ICA showing no obstructive CAD, lower cumulative radiation exposure and estimated costs and greater improvement in QOL.
- CT angiography
- CT-derived fractional flow reserve (FFRCT)
- non-invasive chest pain evaluation
- stable chest pain
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Footnotes
Funding RC reports support from the Irish Board for Training in Cardiovascular Medicine sponsored by MSD; PSD has received research grants from HeartFlow during the conduct of the study and other support from GE Medical systems outside the submitted work; MG reports speaker fees of Siemens, Philips, Bayer and Bracco; ; AW is an employee of HeartFlow; GP reports speakers fees from GE Healtchare, Bracco and Medtronic; MAH consults for the Blue Cross Blue Shield Association and received a research grant from HeartFlow during the conduct of the study; FW served as a consultant for HeartFlow during the conduct of the study and received financial compensation for these services; CR is an employee of HeartFlow and reports a salary and equity from HeartFlow; RAB reports receiving institutional research grants from Boston Scientific and HeartFlow and lecture fees from B. Braun Melsungen AG, Biotronik and Boston Scientific.
Competing interests None declared
Provenance and peer review Not commissioned; externally peer reviewed
Data sharing statement No additional data are available