An FFRCT diagnostic strategy versus usual care in patients with suspected coronary artery disease planned for invasive coronary angiography at German sites: one-year results of a subgroup analysis of the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) study

Roisin Colleran; Pamela S Douglas; Martin Hadamitzky; Matthias Gutberlet; Lukas Lehmkuhl; Borek Foldyna; Michael Woinke; Ulrich Hink; Jonathan Nadjiri; Alan Wilk; Furong Wang; Gianluca Pontone; Mark A Hlatky; Campbell Rogers; Robert A Byrne

doi:10.1136/openhrt-2016-000526

An FFR_CT diagnostic strategy versus usual care in patients with suspected coronary artery disease planned for invasive coronary angiography at German sites: one-year results of a subgroup analysis of the PLATFORM (Prospective Longitudinal Trial of FFR_CT: Outcome and Resource Impacts) study

Open Heart. 2017 Mar 22;4(1):e000526. doi: 10.1136/openhrt-2016-000526. eCollection 2017.

Authors

Affiliations

¹ Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
² Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
³ Department of Diagnostic and Interventional Radiology, University of Leipzig Heart Centre, Leipzig, Germany.
⁴ Department of Cardiology, University of Leipzig Heart Centre, Leipzig, Germany.
⁵ Department of Cardiology, Johannes Gutenberg University Hospital, Mainz, Germany.
⁶ HeartFlow, Redwood City, California, USA.
⁷ Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
⁸ Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California, USA.

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 (FFR_CT) diagnostic strategy with usual care in patients with planned invasive coronary angiography (ICA) enrolled in the PLATFORM (Prospective Longitudinal Trial of FFR_CT: 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)/FFR_CT. 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/FFR_CT 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/FFR_CT. Clinical event rates were low overall. The mean radiation exposure was lower in the FFR_CT versus the usual care group (7.28 vs 9.80 mSv, p<0.001). Mean estimated medical costs were €4217 (CTA/FFR_CT) versus €6894 (usual care), p<0.001. Improvement in QOL (EQ-5D score) was greater in the FFR_CT (+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/FFR_CT 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.

Keywords: CT angiography; CT-derived fractional flow reserve (FFRCT); non-invasive chest pain evaluation; stable chest pain.

Publication types

Research Support, Non-U.S. Gov't