The recent presentation of the PROVISION1 Study at the TCT conference in Washington, D.C. showcased the groundbreaking results of the first randomized controlled trial comparing FFRangio outcomes to traditional wire-based FFR. The study, led by investigators from Gifu Heart Center and Fukuoka Sanno Hospital, demonstrated that the non-invasive FFRangio technology offers significant economic and resource utilization advantages over invasive wire-based approaches.
The study enrolled 400 patients across 13 centers in Japan, with the aim of confirming that the wire-free angiography-based FFRangio System yields comparable clinical treatment plans to invasive wire-based FFR, without any differences in clinical prognoses. The FFRangio System utilizes AI and advanced computational science to provide quick and reliable intraprocedural FFRangio values for the entire coronary tree, eliminating the need for pressure wires and drug stimulation.
Key findings from the study included the achievement of the primary endpoint, showcasing the non-inferiority of FFRangio in revascularization decisions, as well as significant economic advantages and resource utilization improvements. The study also highlighted the patient comfort and safety benefits of FFRangio as a non-invasive approach.
Professor Matsuo and Professor Yokoi, the principal investigators of the study, emphasized the potential of FFRangio as a game-changer in coronary artery disease diagnostics in Japan. They anticipate that the results of the study will provide valuable insight on optimal cut-off values for post-PCI FFR measurements, encouraging routine post-procedural physiology assessments.
Overall, the PROVISION1 Study demonstrated the clinical efficacy, economic benefits, and operational efficiencies of the FFRangio technology, positioning it as a promising alternative to invasive wire-based FFR for the diagnosis and treatment of coronary artery disease.
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