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, 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. Guerlek, G. Pundziute, R. Vliegenthart, R. P. J. Budde*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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.

Original languageEnglish
Pages (from-to)52-60
Number of pages9
JournalNetherlands Heart Journal
Volume31
Issue number2
Early online date17 Aug 2022
DOIs
Publication statusPublished - Feb 2023

Bibliographical note

Funding Information:
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.

Funding Information:
This work was supported by the Dutch Ministry of Health and the Dutch National Health Care Institute (Zorginstituut Nederland) as part of the research programme ‘Potentially Promising Care’ (‘Veelbelovende Zorg’) and HeartFlow, Inc.

Funding Information:
This work was supported by the Dutch Ministry of Health and the Dutch National Health Care Institute (Zorginstituut Nederland) as part of the research programme ‘Potentially Promising Care’ (‘Veelbelovende Zorg’) and HeartFlow, Inc.

Publisher Copyright:
© 2022, The Author(s).

Publisher Copyright:
© 2022, The Author(s).

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