The results of the ALL-RISE Trial were presented at the American College of Cardiology’s Annual Scientific Session (ACC.26) in New Orleans on March 29, showing that CathWorks FFRangio, an angiography-derived physiology system, demonstrated similar clinical outcomes to traditional invasive wire-based assessments for coronary artery disease. The findings were also published in the New England Journal of Medicine.
This study is significant as it represents the first randomized controlled trial in the United States to compare an FDA-approved angiography-derived physiology solution with both fractional flow reserve and non-hyperemic pressure ratio tools for physiologic lesion assessment. The trial enrolled 1,930 patients across 59 sites worldwide, randomizing them to either CathWorks FFRangio or a pressure wire-based approach.
At one year, rates of major adverse cardiac events—including death, myocardial infarction, or unplanned revascularization—were nearly identical between groups: 6.9% for those assessed with FFRangio and 7.1% for those using pressure wires. Both groups had similar safety profiles regarding bleeding and acute kidney injury. The FFRangio group benefited from improved resource use in catheterization labs through reduced radiation exposure and less contrast medium usage, along with shorter procedure times.
In a joint statement by Drs. Martin B. Leon, Ajay J. Kirtane, William Fearon, and Allen Jeremias it was said: “Progress in cardiovascular disease is driven by strong partnership, relentless discovery and clinical rigor that challenges existing practices. The ALL-RISE Trial is a landmark, randomized controlled trial assessing how artificial intelligence and advanced computational science can obtain physiologic information once only obtained by an invasive procedure… With significant workflow advantages and a suite of intraprocedural tools that help optimize clinical decision making, CathWorks FFRangio can help advance cardiovascular care for clinicians and patients.” Ramin Mousavi of CathWorks said: “We are grateful to the investigators… whose commitment to advancing science made the ALL-RISE Trial possible… The positive results from this landmark study add to an already robust body of clinical evidence generated from thousands of patients treated globally according to FFRangio guidance… paving the way for CathWorks FFRangio to become the new standard of care for improving patient outcomes.” Jason Weidman from Medtronic said: “Through our strategic partnership with CathWorks… we have seen excitement and global adoption… We are excited for the future with CathWorks and believe FFRangio is poised to become a new standard worldwide.”
CathWorks’ technology uses artificial intelligence combined with computational science on routine angiograms without needing drug stimulation or invasive wires; it provides full coronary tree assessments including virtual pullback curves validated against ultrasound measurements.
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The ALL-RISE results may influence broader adoption of non-invasive technologies like CathWorks’ system within cardiology practice worldwide.
