Fractional flow reserve or 3D-quantitative-coronary-angiography based vessel-FFR guided revascularization. Rationale and study design of the prospective randomized fast III trial - 03/05/23

Doi : 10.1016/j.ahj.2023.02.003

Alessandra Scoccia, MD, ¹, Robert A. Byrne, MB, BCh, PhD, FESC, ^2,³, Adrian P. Banning, MD, ⁴, Ulf Landmesser, MD, ⁵, Eric Van Belle, MD, PhD, ^6,⁷, Ignacio J. Amat-Santos, MD, ⁸, Manel Sabaté, MD, ⁹, Jan G.P. Tijssen, PhD, ¹⁰, Ernest Spitzer, MD, ^1,¹¹, Joost Daemen, MD, PhD, FESC ^1,^⁎
¹ Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands
² Dept. of Cardiology and Cardiovascular Research Institute (CVRI) Dublin, Mater Private Network, Dublin, Ireland
³ School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland
⁴ Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom
⁵ Department of Cardiology, Charite Universitätsmedizin Berlin, German Center of Cardiovascular Research (DZHK) – Partner Site Berlin; Germany
⁶ Department of Cardiology, Institut Cœur Poumon, CHU Lille, Lille, France
⁷ Department of Interventional Cardiology for Coronary Valves and Structural Heart Diseases, Inserm, U1011, Institut Pasteur de Lille, EGID, Université de Lille, Lille, France
⁸ Cardiology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
⁹ Cardiology Department, Cardiovascular Institute (ICCV), Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain
¹⁰ Cardialysis BV, Rotterdam, The Netherlands
¹¹ European Cardiovascular Research Institute, Rotterdam, The Netherlands

^⁎Reprint requests: J. Daemen, MD, PhD, FESC, Department of Cardiology, room Rg-628, Erasmus University Medical Center, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands. Tel.: +31 10 703 52 60; Fax: +31 10 703 52 54.Department of Cardiology, room Rg-628P.O. Box 2040RotterdamCA3000the Netherlands

Riassunto

Background

Physiological assessment of intermediate coronary lesions to guide coronary revascularization is currently recommended by international guidelines. Vessel fractional flow reserve (vFFR) has emerged as a new approach to derive fractional flow reserve (FFR) from 3D-quantitative coronary angiography (3D-QCA) without the need for hyperemic agents or pressure wires.

Study design and objectives

The FAST III is an investigator-initiated, open label, multicenter randomized trial comparing vFFR guided versus FFR guided coronary revascularization in approximately 2228 patients with intermediate coronary lesions (defined as 30%-80% stenosis by visual assessment or QCA). Intermediate lesions are physiologically assessed using on-line vFFR or FFR and treated if vFFR or FFR ≤0.80. The primary end point is a composite of all-cause death, any myocardial infarction, or any revascularization at 1-year post-randomization. Secondary end points include the individual components of the primary end point and cost-effectiveness will be investigated.

Conclusions

FAST III is the first randomized trial to explore whether a vFFR guided revascularization strategy is non-inferior to an FFR guided strategy in terms of clinical outcomes at 1-year follow-up in patients with intermediate coronary artery lesions.

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Abbreviations : ACS, AUC, CEC, CI, DEFER, DOCE, DPR, DSMB, ECG, ESC, FAME, FAST, FFR, iFR, ITT, LAD, MI, mITT, NHPR, NSTE-ACS, OR, PCI, POCE, QCA, QoL, RFR, SAQ, SCAI, SOCE, STEMI, TIMI, vFFR

Mappa

Study design and objectives

Patient population

Screening, enrollment, and randomization

Invasive procedure

vFFR computation

FFR measurement

Post-procedural care and follow-up

Study end points

Statistical considerations

Study organization, timelines, and ethical concerns

Discussion

Current status

Conclusion

Clinical Trial Registration: ClinicalTrials.gov, Unique Identifier: NCT04931771.

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Vol 260

P. 1-8 - giugno 2023 Ritorno al numero

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Fractional flow reserve or 3D-quantitative-coronary-angiography based vessel-FFR guided revascularization. Rationale and study design of the prospective randomized fast III trial - 03/05/23

Riassunto

Background

Study design and objectives

Conclusions

Mappa

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