FAST III trial demonstrates non-inferiority of CAAS vFFR to invasive wire-based FFR

• PR Newswire

MAASTRICHT, Netherlands, March 29, 2026 /PRNewswire/ -- Pie Medical Imaging, a global leader in cardiac imaging analysis Solutions announces the result of the FAST III trial, presented during the Late-Breaking Clinical Trials session at the Congress of the American College of Cardiology (ACC) 2026 and published in the New England Journal of Medicine. The trial confirms non-inferiority of revascularization guided by CAAS vFFR to revascularization guided by pressure wire-based FFR.

FAST III was an investigator-initiated, open label, multicenter randomized trial comparing vFFR guided versus FFR guided coronary revascularization in 2235 patients with intermediate coronary lesions (defined as 30%-80% stenosis by visual assessment or QCA). Intermediate lesions were physiologically assessed using table side vFFR or FFR and treated if vFFR or FFR ≤0.80. The primary end point was a composite of all-cause death, any myocardial infarction, or any revascularization at 1-year post-randomization.

Following the tremendous efforts of the principal investigator, Dr. Joost Daemen, cardiologist in the Thoraxcenter at the Erasmus University Medical Center in Rotterdam, Netherlands. 37 participating centers and ECRI (sponsor of the trial), the trial has met its primary endpoint, showing identical MACE rates in the vFFR-guided group and the FFR-guided group.

," said Dr. Joost Daemen.

Bas Kuppens, CEO at Pie Medical Imaging adds:

Doris Pommi, head of Cardiovascular Care at Siemens Healthineers, added: ""

The trial is funded by research grants from Pie Medical Imaging (Maastricht, The Netherlands) and Siemens Healthineers AG (Forchheim, Germany). The study is sponsored by ECRI (European Cardiovascular Research Institute, Rotterdam-the Netherlands). Cardialysis (Rotterdam, The Netherlands) is responsible for trial services including trial management and Core Laboratory activities.

Pie Medical Imaging is a global leader in advanced cardiovascular image analysis, quantification and visualization. Based in Maastricht, The Netherlands, the company oversees worldwide innovation and commercialization of the CAAS and 3mensio product lines. With decades of expertise and deep commitment to innovation, Pie Medical Imaging delivers software solutions that empower clinicians, researchers, and industry partners to enhance diagnosis, procedure planning, and image-guided interventions.

The company complies with international quality and regulatory standards, ensuring high reliability and clinical confidence.

Pie Medical Imaging is part of the Esaote Group, a leader in the biomedical equipment sector.

More information about Pie Medical Imaging is available at .

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