PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR
PARIS, May 22, 2025 /PRNewswire/ -- Today at the annual EuroPCR conference taking place in Paris, France, Dr. Toru Tanigaki of Gifu Heart Center in Gifu, Japan presented the one-year results of the physician-initiated PROVISION1 Study. At TCT 2024, investigators shared that the PROVISION Study met its non-inferiority primary endpoint and revealed economic and resource utilization advantages for the FFRangio technology over traditional invasive FFR.
The PROVISION Study is the first Japanese prospective randomized controlled trial (RCT) comparing the outcomes of an angio-based technology compared to invasive wire-based physiology and enrolled 401 patients across 13 centers in Japan. Patients with intermediate coronary lesions (30-90% diameter stenosis) were randomized 1:1 to either the wire-based FFR arm, in which the treatment decision was determined based on FFR values obtained using an invasive pressure wire, or the FFRangio arm, in which the treatment decision was based on FFRangio values. Based on the functional evaluations, either revascularization (PCI) and optimal medical management (OMT) or OMT alone were selected, and patients were followed clinically for at least one year.
During a Hotline / Late-Breaking Trials session at EuroPCR 2025, Dr. Tanigaki presented the rates of major adverse cardiac events (MACE) at one year for patients treated according to FFRangio guidance versus FFR guidance. MACE was defined as a composite of death from any cause, nonfatal myocardial infarction (MI) or unplanned revascularization. MACE at one year was 9.9% for the FFRangio arm versus 12.6% for the FFR arm [HR 0.80 (0.42 to 1.51), p = 0.489]. MACE excluding periprocedural MI was 3.5% for the FFRangio arm versus 6.0% for the FFR arm [HR 0.58 (0.13 to 1.42), p = 0.167]. The rates of all-cause death, myocardial infarction and target vessel revascularization at one year were all similar in the FFRangio arm and FFR arm.
"The CathWorks FFRangio® System has already demonstrated the highest diagnostic accuracy compared to wire-based FFR among non-hyperemic indices and angio-based technologies. The FFRangio System not only eliminates the drawbacks of invasive wire-based technologies that have limited the overall adoption of physiology but also provides tools that optimize clinical decision making. With the addition of this new body of clinical evidence demonstrating patients treated according to FFRangio guidance have similar outcomes to those treated based on invasive FFR guidance while potentially reducing procedural resources and costs, we are truly embarking on a new era in physiology, transforming FFRangio into the new standard of care," said Ramin Mousavi, CathWorks President & CEO.
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.
1.
Prospective Randomized trial of clinical Outcomes of angiography-based fractional flow reserve guidance Versus wIre-baSed fractIOnal flow reserve guidance (PROVISION) study is an investigation of the Utility of Coronary Angiography (FFRangio) in Comparison to Coronary Fractional Flow Reserve (FFR) in the Determination of Treatment Planning and the Clinical Prognosis in Patients with Chronic Phase Coronary Artery Disease
Investors:Mike Fehermike.feher@cath.works
Media:Sarita Monicosarita.monico@cath.works
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Scientists have detected the largest black hole merger yet. What it is and why it matters
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"But this event in particular is very interesting because it's the most massive one." Gravitational waves are ripples in space-time that can only be detected by extremely sensitive instruments, like the ones from the collaboration, which are located across the United States, Japan and Italy. The first gravitational wave was detected in 2015 and announced by astronomers in 2016. The other interesting discovery of this detection — called GW231123 — is that the pair appear to have been spinning extremely quickly. "The black holes appear to be spinning very rapidly — near the limit allowed by [Albert] Einstein's theory of general relativity," Charlie Hoy at the University of Portsmouth said in a statement. "That makes the signal difficult to model and interpret. It's an excellent case study for pushing forward the development of our theoretical tools." Understanding black holes Not all black holes are created equal. There are supermassive black holes that can be tens of thousands to billions of times the sun's mass and lie at the centre of galaxies. The Milky Way, for example, has a black hole at its centre, called Sagittarius A* — or Sgr A* — that is roughly four million times the mass of the sun. Then there are stellar-mass black holes, which can be from a few times the mass of the sun to tens of times the mass. Or, some argue, a hundred of times its mass. These form when a massive star runs out of fuel and explodes in a spectacular fashion, an event called a supernova. But then there are those that lie somewhere in between the two, called intermediate black holes. Finding these in-betweens has proved difficult for astronomers. This new merger lies within what astronomers call the "mass gap" between stellar-mass and supermassive black holes. Gobbling up stars It's not quite clear why these two black holes were so much heavier than what astronomers have previously detected. One theory is that each of the pair itself was the result of two black holes merging. But that's not the only theory. Priya Natarajan, professor of physics and the chair of astronomy at Yale University, studies supermassive black holes. Though these two black holes are piddly compared to the ones she studies, she says she is excited about the recent detection. "I think this is super exciting for two reasons. First is the heaviness of the individual black holes before they actually merge," said Natarajan, who was not involved with the findings. "So the fact is that, you know, normal stellar processes that give you these stellar-mass remnant black holes, it's pretty hard to imagine, like, getting to 100 and 140 in one go." But she has another theory on how these two unusual black holes could have formed. In 2014, she co-authored a paper that suggested black holes could grow rapidly in the early universe by first going supernova and then by gobbling up stars in a nascent star cluster, à la Pac-Man. More gas means larger black holes. But she says in 2021, she realized this could happen later in the more recent universe, as well. "The only thing that is different is there's not as much gas," she said. "So I actually showed that if there's not that much gas, you could start with something that's one or ten times the mass of the sun. It could maybe reach 100.… If there's little more gas, it could be 1,000." So this new finding could open up a new avenue for cosmologists like herself to explore. The next thing she'd like to see is a better way to locate these mergers. For the recent detection, there is an estimate that it occurred anywhere from two to 13 billion light years away. Now, why are these findings important? It's about the human connection with the universe, Natarajan said. "I think from the moment that as Neanderthals we stood upright and we were able to look at the night sky, we were fascinated with the regularity of the night sky, as well as the sort of cosmic drama that's going on, right? You see stars exploding, you see eclipses, you see night and day, you see seasonal changes. And I think it speaks to a fundamental curiosity that we as humans have," she said. "I think that knowing our place in the universe is a question that's deeply fundamental to us. And it always has been."
