New Findings from the PROVISION Study Highlight Clinical Similarity of FFRangio and Traditional FFR

The PROVISION Study: A Leap Forward in Coronary Intervention

The annual EuroPCR conference in Paris recently witnessed a significant presentation from Dr. Toru Tanigaki from Gifu Heart Center, Japan. He unveiled the one-year results of the PROVISION study, a pioneering clinical trial comparing the effectiveness of FFRangio to traditional wire-based Fractional Flow Reserve (FFR) guidance. This research has the potential to reshape treatment paradigms for coronary artery disease.

Study Overview

The PROVISION study is notable as Japan’s first prospective randomized controlled trial examining angio-based and wire-based technologies. Involving 401 patients from 13 medical centers, it specifically evaluated individuals with intermediate coronary lesions ranging from 30% to 90% diameter stenosis.

Participants were divided into two arms: one group received treatment based on traditional wire-based FFR values while the other utilized the innovative FFRangio technology. Following detailed assessments, doctors determined whether patients required revascularization (Percutaneous Coronary Intervention - PCI) combined with optimal medical therapy, or if they could be managed solely with medication. All patients were monitored for at least a year post-treatment.

Key Findings

During a pivotal session at EuroPCR 2025, Dr. Tanigaki presented groundbreaking results concerning the rates of major adverse cardiac events (MACE) for participants guided by FFRangio compared to those directed by traditional FFR. MACE, defined as a combination of death from any cause, nonfatal myocardial infarction (MI), or unplanned revascularization, was documented at one year.

The statistics showed that the MACE rate in the FFRangio cohort was 9.9%, while it reached 12.6% in the traditional FFR group (Hazard Ratio [HR] 0.80, p = 0.489). Notably, when excluding peri-procedural MIs, the MACE rate was considerably lower at 3.5% for FFRangio versus 6.0% for FFR (HR 0.58, p = 0.167). Overall, occurrences of all-cause mortality, myocardial infarction, and target vessel revascularization were similar across both treatment groups, signaling comparable outcomes.

Clinical Implications

Dr. Ramin Mousavi, President and CEO of CathWorks, emphasized the significance of these results, asserting that the FFRangio system already demonstrates superior diagnostic accuracy against traditional wire-based methods. By overcoming many hurdles associated with invasive procedures, FFRangio not only streamlines the diagnosis but also enhances clinical decision-making efficiency.

The integration of this new evidence, indicating that the clinical outcomes for patients treated with FFRangio guidance closely mirror those treated with conventional methods, hints at a transformative phase in the understanding and management of coronary artery disease. Moreover, practitioners might face a shift in resource allocation and cost-effectiveness, with potential advantages highlighted for FFRangio.

As the healthcare sector continually pursues advancements that balance patient safety and treatment efficacy, the PROVISION study stands as a beacon for future practices in cardiology, heralding FFRangio not only as an alternative but possibly as a new standard in care.

About CathWorks

CathWorks is at the forefront of digital health innovations, aiming to enhance patient outcomes globally. The FFRangio system, which capitalizes on artificial intelligence and advanced computational techniques, transforms how cardiovascular disease is diagnosed. By deriving physiological insights from standard angiograms without invasive pressures, it allows for swift and accurate evaluations, marking a significant step forward in cardiac care.

For further details on CathWorks and their offerings, visit www.cath.works and follow them on LinkedIn at @CathWorks.