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PROVISION Study, Prospective Randomized Trial Evaluating Clinical Outcomes of FFRangio Versus FFR Guidance, Demonstrates Similar MACE Rates at One Year
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 Feher
mike.feher@cath.works
Media:
Sarita Monico
sarita.monico@cath.works
PROVISION Study, Prospective Randomized Trial Evaluating Clinical Outcomes of FFRangio Versus FFR Guidance, Demonstrates Similar MACE Rates at One Year
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 Feher
mike.feher@cath.works
Media:
Sarita Monico
sarita.monico@cath.works
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR
BEIJING, Dec. 31, 2025 /PRNewswire/ -- On December 29, China's Ministry of Natural Resources released a survey report on the coral reef ecosystem of Huangyan Dao. Based on this report, CMG Voice of the South China Sea released the ecological documentary An Unfading Commitment: Why Huangyan Dao Needs Protection.
This latest report, spanning four decades from 1985 to 2025, draws on data from over 60 research voyages, and integrates 16 years of satellite remote sensing data. It shows that the coral reef ecosystem of Huangyan Dao National Nature Reserve is generally in good condition.
The documentary An Unfading Commitment: Why Huangyan Dao Needs Protection presents audiences with the healthy and lush seagrass, as well as the rare and endangered wildlife freely inhabiting the Huangyan Dao National Nature Reserve, such as the Green Turtle, Hawksbill Turtle, and Spotted Eagle Ray. At the same time, the film conveys scientists' concerns: threats represented by the fourth global coral bleaching event are ever present. This survey also identified the presence of a small number of crown of thorns starfish in the waters around Huangyan Dao, and the risk of future outbreaks cannot be ruled out.
Today, more than 2,500 marine protected areas involving coral reefs have been established worldwide. The establishment of Huangyan Dao National Nature Reserve is undoubtedly a solemn commitment made by the Chinese people, in the hope that it will inspire more people to help maintain and enhance the diversity, stability, and sustainability of the coral reef ecosystem of Huangyan Dao.
https://vscs.cri.cn/20251229/d487c6b7-8724-4ad6-bf75-968c8dcac4cc.html
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Release of the Latest Ecological Documentary on Huangyan Dao: An Unfading Commitment: Why Huangyan Dao Needs Protection
