CathWorks FFRangio Demonstrates Non-Inferiority to Invasive Pressure Wire Assessment in Landmark ALL-RISE Trial
核心洞察
The ALL-RISE trial, involving 1,930 patients across 59 global sites, demonstrated that CathWorks FFRangio (搜索) met non-inferiority to invasive pressure wire guidance for major adverse cardiac events at one year.
FFRangio showed a primary endpoint event rate of 6.9% compared to 7.1% for the pressure wire group, with improved resource utilization including reduced radiation exposure and shorter procedure times.
A separate US Medicare study of over 4,000 patients showed comparable clinical outcomes through 2 years, with ADP utilization growing nearly 8-fold between 2019 and 2024.
The landmark ALL-RISE trial has demonstrated that CathWorks FFRangio (搜索), an angiography-derived physiology (ADP) technology, achieves non-inferiority to invasive pressure wire guidance for assessing coronary stenoses, marking a potential paradigm shift in cardiovascular interventional procedures. The results were presented at the American College of Cardiology's Annual Scientific Session (ACC.26) and simultaneously published in the New England Journal of Medicine.
ALL-RISE Trial Results Show Clinical Equivalence
The randomized controlled trial enrolled 1,930 patients across 59 global sites in North America, Asia, Europe, and the Middle East. Patients with coronary stenoses of intermediate significance were randomized to physiological assessment with CathWorks FFRangio (搜索) (965 patients) or invasive pressure wire-based approaches including fractional flow reserve (FFR) or non-hyperemic pressure ratio (NHPR) tools (965 patients).
At one year, the primary endpoint of death, myocardial infarction, or unplanned clinically indicated revascularization occurred in 6.9% of the FFRangio group compared to 7.1% of the pressure wire group (HR 0.98; 95% CI 0.70 to 1.39), meeting non-inferiority with a p-value of 0.0008. Both groups demonstrated similar safety profiles with no apparent differences in bleeding, acute kidney injury, or procedure-related adverse events.
Operational Advantages in Clinical Practice
Beyond clinical equivalence, the FFRangio group demonstrated significant operational benefits. The technology reduced radiation exposure and contrast medium usage compared to invasive pressure wire approaches. Despite a slightly higher rate of percutaneous coronary intervention, the FFRangio group showed shorter assessment times for physiology analysis and reduced overall procedure duration.
"The compelling results of the ALL-RISE Trial demonstrating CathWorks FFRangio (搜索) had similar clinical outcomes to the current reference standard should serve as the impetus to increase adoption of physiology worldwide," stated the trial's executive leadership team, including Dr. Martin B. Leon, Dr. Ajay J. Kirtane, Dr. William Fearon, and Dr. Allen Jeremias.
Real-World Evidence from US Medicare Data
Complementing the randomized trial data, a separate analysis of US Medicare outcomes from 2019 to 2024 examined over 466,535 invasive physiology assessments. The study showed ADP utilization grew nearly 8-fold during this period, with 1,591 ADP patients matched 1:3 with 4,773 invasive pressure wire patients in the PCI group.
The cumulative incidence of major adverse cardiac events through 2 years was comparable between groups: 24.8% for ADP versus 23.5% for invasive pressure wire (HR 1.01, 95% CI 0.85-1.20). In patients who did not undergo PCI, 2,532 ADP patients matched with 7,596 pressure wire patients showed similar MACE rates of 24.1% versus 23.9% (HR 0.97, 95% CI 0.84-1.11).
Technology Platform and Clinical Integration
The CathWorks FFRangio (搜索) System utilizes artificial intelligence and advanced computational science to derive physiologic information from routine angiograms through a resistance-based approach. The technology eliminates the need for drug stimulation and invasive pressure wires while providing physiology values across the entire coronary tree.
The platform includes additional tools such as virtual pullback curves, a Lesion Impact tool for assessing residual ischemia in tandem lesion cases, and an integrated sizing tool validated against intravascular ultrasound for PCI planning support.
Dr. Eric A. Secemsky, Director of Vascular Intervention at Beth Israel Deaconess Medical Center, noted, "When considering the promising secondary outcomes such as resource utilization advantages and the growing clinical body of evidence, specifically for CathWorks FFRangio (搜索), we expect the current trend of adoption for ADP to continue to grow at an even faster rate."
Strategic Partnership and Market Position
Medtronic's partnership with CathWorks (搜索) has facilitated global adoption of the FFRangio technology. Jason Weidman, Senior Vice President and President of Medtronic's Coronary & Renal Denervation business, stated, "The ALL-RISE data affirm our confidence in FFRangio's transformative impact on the diagnosis and treatment of coronary artery disease."
Ramin Mousavi, CathWorks (搜索) President & CEO, emphasized that "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."
The convergence of randomized trial data and real-world evidence positions CathWorks FFRangio (搜索) as a potential new standard of care for coronary physiology assessment, offering clinicians a non-invasive alternative that maintains clinical efficacy while improving procedural efficiency.