Late-Breaking Clinical Trial Presentation of the First-Ever US Cohort of Over 4,000 CathWorks FFRangio Patients Demonstrates Similar Clinical Outcomes to Invasive Pressure Wire-Guided PCI through 2 Years

WASHINGTON, March 7, 2026 /PRNewswire/ — Today at the Cardiovascular Research Technologies (CRT) annual conference taking place in Washington, DC, Dr. Christopher Chieh Yang Koo from National University Hospital Singapore, on behalf of investigators from Smith Center for Outcomes Research in Cardiology at Harvard Medical School, presented the first-ever US Medicare outcomes data for angiography-derived physiology (ADP) in a Late-Breaking Clinical Trial (LBCT) that was simultaneously published in Circulation: Cardiovascular Interventions. This study highlights the rapidly growing adoption of CathWorks FFRangio in the United States while demonstrating similar clinical outcomes as invasive pressure wire-guided PCI through 2 years.

The Medicare data from 2019 to 2024 were used to identify inpatient and outpatient physiological assessments performed with ADP or invasive pressure wire. ADP was propensity matched 1:3 to invasive pressure wire in patients who underwent PCI and separately in those who did not undergo PCI. The primary outcome was the cumulative incidence of major adverse cardiac events (MACE) through 2 years (death, myocardial infarction (MI) or repeat revascularization). Secondary outcomes included each component of MACE, 30-day acute kidney injury and major bleeding. Cost ratios for repeat revascularization and hospital readmissions through 1 year were calculated.

Among 466,535 invasive physiology assessments, ADP utilization grew nearly 8-fold between 2019 and 2024. In the PCI group, 1,591 ADP and 4,773 invasive pressure wire matched patients, the cumulative incidence of MACE was comparable through 2 years (24.8% vs. 23.5%; HR 1.01, 95% CI 0.85-1.20). In the non-PCI group, 2,532 ADP and 7,596 invasive pressure wire matched patients also had comparable MACE through 2 years (24.1% vs. 23.9%; HR 0.97, 95% CI 0.84-1.11).

“This first look at contemporary data of the growing adoption of ADP in the United States shows similar clinical outcomes including death, MI and revascularization through 2 years when compared with invasive pressure wires. When considering the promising secondary outcomes such as resource utilization advantages and the growing clinical body of evidence, specifically for CathWorks FFRangio, we expect the current trend of adoption for ADP to continue to grow at an even faster rate,” said Dr. Eric A. Secemsky, Director of Vascular Intervention at Beth Israel Deaconess Medical Center.

“This large US cohort adds to the strategically planned robust body of clinical evidence for CathWorks FFRangio. Considering these data were predominantly based on an earlier generation of CathWorks FFRangio and taking into account the commercial adoption over the last few years, we are very encouraged that the latest innovations within the CathWorks platform further streamline its integration within the clinical workflow while still providing similar outcomes. CathWorks FFRangio is well positioned to become the new standard of care for physiology, but all ADP technologies are not created equally and do not yield similar outcomes. Each technology should be evaluated based on its own peer-reviewed clinical evidence,” said Ramin Mousavi, CathWorks President & CEO.

Read the simultaneously published study: https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.016213

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

Source link