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. 2023 Feb;31(2):52-60.
doi: 10.1007/s12471-022-01711-w. Epub 2022 Aug 17.

Addition of FFRct in the diagnostic pathway of patients with stable chest pain to reduce unnecessary invasive coronary angiography (FUSION) : Rationale and design for the multicentre, randomised, controlled FUSION trial

S P Sharma  1   2 , A Hirsch  1   2 , M G M Hunink  2   3   4 , M J M Cramer  5 , F A A Mohamed Hoesein  6 , C A Geluk  7 , G Kramer  8 , J W C Gratama  9 , R L Braam  10 , P M van der Zee  11 , W Yassi  11 , S L Wolters  12 , C Gürlek  13 , G Pundziute  14 , R Vliegenthart  15 , R P J Budde  16   17
Affiliations

Addition of FFRct in the diagnostic pathway of patients with stable chest pain to reduce unnecessary invasive coronary angiography (FUSION) : Rationale and design for the multicentre, randomised, controlled FUSION trial

S P Sharma et al. Neth Heart J. 2023 Feb.

Abstract

Background: Coronary computed tomography angiography (CCTA) is widely used in the diagnostic work-up of patients with stable chest pain. CCTA has an excellent negative predictive value, but a moderate positive predictive value for detecting coronary stenosis. Computed tomography-derived fractional flow reserve (FFRct) is a non-invasive, well-validated technique that provides functional assessment of coronary stenosis, improving the positive predictive value of CCTA. However, to determine the value of FFRct in routine clinical practice, a pragmatic randomised, controlled trial (RCT) is required. We will conduct an RCT to investigate the impact of adding FFRct analysis in the diagnostic pathway of patients with a coronary stenosis on CCTA on the rate of unnecessary invasive coronary angiography, cost-effectiveness, quality of life and clinical outcome.

Methods: The FUSION trial is a prospective, multicentre RCT that will randomise 528 patients with stable chest pain and anatomical stenosis of ≥ 50% but < 90% in at least one coronary artery of ≥ 2 mm on CCTA, to FFRct-guided care or usual care in a 1:1 ratio. Follow-up will be 1 year. The primary endpoint is the rate of unnecessary invasive coronary angiography within 90 days.

Conclusion: The FUSION trial will evaluate the use of FFRct in stable chest pain patients from the Dutch perspective. The trial is funded by the Dutch National Health Care Institute as part of the research programme 'Potentially Promising Care' and the results will be used to assess if FFRct reimbursement should be included in the standard health care package.

Keywords: Angina; Computed tomography angiography; Coronary angiography; Coronary artery disease; Fractional flow reserve; Myocardial; Stable.

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Conflict of interest statement

S.P. Sharma, A. Hirsch, M.G.M. Hunink, M.J.M. Cramer, F.A.A. Mohamed Hoesein, C.A. Geluk, G. Kramer, J.W.C. Gratama, R.L. Braam, P.M. van der Zee, W. Yassi, S.L. Wolters, C. Gürlek, G. Pundziute, R. Vliegenthart and R.P.J. Budde declare that they have no competing interests. This study is financially supported by HeartFlow, Inc. In addition, the Erasmus Medical Centre has received support from HeartFlow, Inc. and Siemens for other studies unrelated to the FUSION trial.

Figures

Fig. 1
Fig. 1
Flow chart of the study design. * Clinicians are strongly discouraged from referring these patients for ICA. ** Patients are expected to be treated medically, but there may be instances whereby the clinician overrules this decision. *** Clinicians are encouraged to schedule ICA if coronary revascularisation is considered advisable. **** Decision for ICA depends on symptomatology, stenosis and FFRct location, extent of CAD, number of coronary arteries involved, and comorbidities. In some cases, one may first treat the patient medically to see if the complaints of chest pain disappear. CAD coronary artery disease, CCTA coronary computed tomography angiography, FFRct computed tomography-derived fractional flow reserve, ICA invasive coronary angiography
See this image and copyright information in PMC

References

    1. Nederland Z. Verbetersignalement pijn op de borst (verdenking) stabiele angina pectoris. Zorginstituut Nederland; 2017.
    1. Knuuti J, Wijns W, Saraste A, et al. 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020;41:407–477. doi: 10.1093/eurheartj/ehz425. - DOI - PubMed
    1. NICE . Recent-onset chest pain of suspected cardiac origin: assessment and diagnosis (CG95) 2010. - PubMed
    1. Haase R, Schlattmann P, Gueret P, et al. Diagnosis of obstructive coronary artery disease using computed tomography angiography in patients with stable chest pain depending on clinical probability and in clinically important subgroups: meta-analysis of individual patient data. BMJ. 2019;365:l1945. doi: 10.1136/bmj.l1945. - DOI - PMC - PubMed
    1. Danad I, Szymonifka J, Twisk JWR, et al. Diagnostic performance of cardiac imaging methods to diagnose ischaemia-causing coronary artery disease when directly compared with fractional flow reserve as anbsp;reference standard: anbsp;meta-analysis. Eur Heart J. 2017;38:991–998. - PMC - PubMed

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