PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR

PROVISION Study, Prospective Randomized Trial Evaluating Clinical Outcomes of FFRangio Versus FFR Guidance, Demonstrates Similar MACE Rates at One Year

PARIS, May 22, 2025 /PRNewswire/ — Today at the annual EuroPCR conference taking place in Paris, France, Dr. Toru Tanigaki of Gifu Heart Center in Gifu, Japan presented the one-year results of the physician-initiated PROVISION¹ Study. At TCT 2024, investigators shared that the PROVISION Study met its non-inferiority primary endpoint and revealed economic and resource utilization advantages for the FFRangio technology over traditional invasive FFR.

The PROVISION Study is the first Japanese prospective randomized controlled trial (RCT) comparing the outcomes of an angio-based technology compared to invasive wire-based physiology and enrolled 401 patients across 13 centers in Japan. Patients with intermediate coronary lesions (30-90% diameter stenosis) were randomized 1:1 to either the wire-based FFR arm, in which the treatment decision was determined based on FFR values obtained using an invasive pressure wire, or the FFRangio arm, in which the treatment decision was based on FFRangio values. Based on the functional evaluations, either revascularization (PCI) and optimal medical management (OMT) or OMT alone were selected, and patients were followed clinically for at least one year.

During a Hotline / Late-Breaking Trials session at EuroPCR 2025, Dr. Tanigaki presented the rates of major adverse cardiac events (MACE) at one year for patients treated according to FFRangio guidance versus FFR guidance. MACE was defined as a composite of death from any cause, nonfatal myocardial infarction (MI) or unplanned revascularization. MACE at one year was 9.9% for the FFRangio arm versus 12.6% for the FFR arm [HR 0.80 (0.42 to 1.51), p = 0.489]. MACE excluding periprocedural MI was 3.5% for the FFRangio arm versus 6.0% for the FFR arm [HR 0.58 (0.13 to 1.42), p = 0.167]. The rates of all-cause death, myocardial infarction and target vessel revascularization at one year were all similar in the FFRangio arm and FFR arm.

 “The CathWorks FFRangio^® System has already demonstrated the highest diagnostic accuracy compared to wire-based FFR among non-hyperemic indices and angio-based technologies. The FFRangio System not only eliminates the drawbacks of invasive wire-based technologies that have limited the overall adoption of physiology but also provides tools that optimize clinical decision making. With the addition of this new body of clinical evidence demonstrating patients treated according to FFRangio guidance have similar outcomes to those treated based on invasive FFR guidance while potentially reducing procedural resources and costs, we are truly embarking on a new era in physiology, transforming FFRangio into the new standard of care,” said Ramin Mousavi, CathWorks President & CEO.

ABOUT CATHWORKS

CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio^® System combines artificial intelligence and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit www.cath.works and follow @CathWorks on LinkedIn. 

Investors:
Mike Feher
[email protected]

Media:
Sarita Monico
[email protected]

SOURCE CathWorks