CathWorks FFRangio System Compared to Invasive Wire-Based FFR in PROVISION RCT

November 11, 2024—CathWorks recently announced results from the physician-initiated PROVISION randomized controlled trial (RCT) of the company’s noninvasive FFRangio system compared to invasive wire-based fractional flow reserve (FFR) in the determination of treatment planning and clinical prognosis in patients with chronic-phase coronary artery disease.

The company reported that PROVISION met its primary endpoint and revealed significant economic and resource utilization advantages for the FFRangio versus traditional wire-based FFR approaches.

CathWorks’ FFRangio system combines artificial intelligence and advanced computational science to obtain physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides quick and reliable intraprocedural FFRangio values for the entire coronary tree, stated the company.

Investigators from Gifu Heart Center in Gifu, Japan, and Fukuoka Sanno Hospital in Fukuoka City, Japan, presented the trial’s findings at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

According to CathWorks, the PROVISION study enrolled 400 patients at 13 centers in Japan and was led by Principal Investigators Professor Hitoshi Matsuo, MD, from Gifu Heart Center and Professor Hiroyoshi Yokoi, MD, from Fukuoka Sanno Hospital.

The company stated that PROVISION aimed to confirm that physiological assessment with the wire-free, angiography-based CathWorks FFRangio system yields the same clinical treatment plans as those based on evaluation performed with invasive wire-based FFR, with no difference in clinical prognoses, and that FFRangio offers economic advantages over wire-based FFR.

As summarized in the company’s press release, patients with intermediate coronary lesions (30%-90% diameter stenosis) were randomized 1:1 to either the wire-based FFR arm or the FFRangio arm. In the FFR arm, the treatment decision was determined based on FFR values obtained using an invasive pressure wire. In the FFRangio arm, the treatment decision was based on FFRangio values.

Based on the functional evaluations, either revascularization via percutaneous coronary intervention (PCI) and optimal medical management (OMT) or OMT alone were selected. For patients who underwent PCI, a post-PCI physiological assessment was performed using the respective technology. Patients will be followed clinically for at least 1 year.

In the press release, CathWorks outlined the key findings from PROVISION as follows:

• The primary endpoint was achieved, with FFRangio showing a similar revascularization rate by demonstrating noninferiority of proportion test using a binary variable, confirming its value as a noninvasive diagnostic tool.
• Economic advantages were demonstrated, with a significant reduction in overall costs of approximately $374 and $400 in the OMT and PCI cohorts, respectively, for FFRangio compared to invasive wire-based FFR.
• Resource use improvements were demonstrated, with FFRangio requiring fewer catheterization lab resources, including reduced radiation dose, which translated to increased efficiency compared to invasive wire-based FFR.
• Patient comfort and safety were demonstrated with FFRangio, reducing the need for pressure wires and hyperemic agents and thereby minimizing patient discomfort and potential complications.

“The results from the post-PCI assessments performed on patients who underwent PCI and OMT, planned to be analyzed and reported after the completion of 1-year follow-up, can provide the very much needed insight on optimal cut-off(s) for post-PCI FFR values, and provide the clinical evidence necessary to encourage routine post-PCI physiology assessment,” commented Prof. Yokoi in the CathWorks press release.

Prof. Matsuo added, “The results of this study are groundbreaking for coronary artery disease diagnostics in Japan. FFRangio offers a noninvasive alternative that not only matches the diagnostic accuracy of traditional wire-based FFR but also improves operational efficiencies and reduces costs for health care providers.”