FAST III Trial Validates Non-Inferiority of CAAS vFFR Over Invasive FFR Methods

FAST III Trial Demonstrates Non-Inferiority of CAAS vFFR to Invasive FFR

The FAST III trial, which spanned over five years, aimed to explore whether vascular flow reserve (vFFR) based on angiographic analysis could effectively guide revascularization in patients while delivering therapeutic outcomes comparable to those achieved through the traditional invasive wire-based flow reserve (FFR). The positive results indicating non-inferiority validate the safety and efficacy of using CAAS vFFR, an option that could significantly transform the clinical approach for managing patients with intermediate coronary artery stenosis.

Presenting these findings during the Late-Breaking Clinical Trials session at the American College of Cardiology (ACC) 2026 Congress, Pie Medical Imaging announced the successful outcomes of FAST III, which has been published in the New England Journal of Medicine. The study highlights CAAS vFFR as a viable alternative for guiding revascularization, paving the way for the reimbursement of less invasive tests which could greatly benefit patients requiring assessments for intermediate coronary stenosis.

Study Overview

Involving a robust sample of 2,235 patients, the FAST III trial was a randomized, multicenter, open-label study, assessing the impact of vFFR against the standard pressure-wire guided FFR. The participants exhibited intermediate coronary lesions classified by visual assessment or quantitative coronary angiography (QCA), falling within the 30% to 80% stenosis range. The main evaluation criterion comprised a composite of all-cause mortality, any myocardial infarction, or any revascularization occurring within one year after randomization.

Thanks to the immense efforts and leadership of Dr. Joost Daemen, a cardiologist from the Thoraxcenter at the Erasmus Medical Center in Rotterdam, and collaborative engagements from 37 medical centers and ECRI as the trial sponsor, the study reached its primary objectives, showing equivalent major adverse cardiovascular events (MACE) for the vFFR and FFR-guided groups.

Clinical Implications

Dr. Daemen stated, “The results from the FAST III trial confirm the safety and feasibility of using vFFR as a minimally invasive and easy-to-implement tool to guide revascularization in patients with intermediate coronary lesions requiring physiological assessment.” The significance of this technology lies in its potential to enhance physiological evaluation, usually reliant on visual observations for decision-making on coronary revascularization.

Removing the need for guidewires, invasive coronary tools, and hyperemic agents reduces associated risks and patient discomfort. This shift may lead to more secure, faster, and less cumbersome coronary evaluations, with prospects of lower costs and broader access to essential physiological assessments for coronary lesions.

Bas Kuppens, CEO of Pie Medical Imaging, shared, “FAST III represents a milestone. It confirms that angiography-based physiology is not inferior to conventional pressure-guided physiology. Moreover, it demonstrated advantages including lower dosage requirements, reduced contrast usage, and less procedure preparation time.”

Doris Pommi, Cardiovascular Director at Siemens Healthineers, added that the results achieve a significant milestone for cardiovascular care in Europe, emphasizing the potential for faster and less painful evaluations, which ultimately enhances patient care.

Conclusion

Financing for the study was provided through research grants from both Pie Medical Imaging and Siemens Healthineers. Overall, this trial sets the groundwork for further advancements in cardiac imaging and therapeutic strategies, potentially influencing how coronary artery disease is managed globally and steering towards more innovative, less invasive practices in cardiology.

About Pie Medical Imaging

Headquartered in Maastricht, Netherlands, Pie Medical Imaging specializes in advanced cardiovascular imaging analysis, quantification, and visualization. With decades of innovation and adherence to international quality standards, the company is committed to supporting the medical community with tools that optimize diagnostic and procedural planning for better clinical outcomes. Discover more about Pie Medical Imaging at www.piemedicalimaging.com.