In recent advancements in cardiology, a groundbreaking, minimally invasive method utilizing artificial intelligence has emerged to assess the impact of coronary artery plaques on blood flow. This innovative software, known as FFRangio, has shown similar effectiveness to the conventional, more invasive wire-based procedure, as revealed in a comprehensive international trial presented at the American College of Cardiology’s Annual Scientific Session (ACC.26).
Dr. Ajay J. Kirtane, a professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and the study’s senior author, stated, “Our research indicates that employing the FFRangio software tool in the cath lab yields comparable clinical outcomes at one year to those achieved through the current standard of invasive wire-based assessment. We hope that our findings will encourage broader adoption of coronary physiologic testing, as endorsed by existing guidelines.”
Coronary artery disease (CAD) arises when fatty plaques accumulate in the arterial walls that supply blood to the heart, leading to narrowing and potential blood flow restrictions. Typically, cardiologists utilize coronary angiography (a form of heart X-ray) to visually assess the severity of these blockages and determine the necessity for percutaneous coronary intervention (PCI) or angioplasty. PCI, also known as angioplasty, employs a small balloon and wire-mesh stent to open obstructed arteries. Past research has indicated that incorporating wire-based pressure measurements can more accurately evaluate reduced blood flow and the benefits of PCI for patients.
In wire-based assessments, physicians first insert a wire or catheter into the blocked artery, administering a medication to enhance blood flow to the heart. This approach enables precise calculations of blood flow beyond the obstruction. Despite evidence of improved patient outcomes and recommendations in treatment guidelines, the adoption of this technique has remained low, likely due to the additional steps and time required for wire placement and measurement.
Emerging minimally invasive methods to assess coronary pressures and flow are currently under investigation in clinical trials. These innovative techniques typically employ advanced computer modeling of images from coronary angiograms to determine if arterial blockages are hindering blood flow. By eliminating the need for medication and catheter insertion, these methods simplify the assessment process. However, a randomized trial on one such approach, known as quantitative flow ratio (QFR), published in 2024, was unable to demonstrate equivalence to wire-based testing.
FFRangio represents a novel technique that utilizes computer software and artificial intelligence to generate a three-dimensional model from coronary angiograms. It quantitatively assesses whether narrowed arteries are restricting blood flow to the heart. The ALL-RISE trial aimed to evaluate the effectiveness of FFRangio compared to traditional wire-based measurements in patients with CAD undergoing assessment for PCI.
The study involved 1,930 participants (average age 68, 75% male, 60% white) across the United States and four additional countries (Israel, Japan, Switzerland, and the U.K.). Patients were randomly assigned to receive either FFRangio analysis or conventional wire-based pressure evaluations to inform PCI decisions. Approximately 17% had a prior heart attack, 40% had undergone previous PCI, and around 80% presented with high blood pressure and cholesterol levels. About 40% of the patients had diabetes, with 12% requiring insulin treatment. The primary endpoint of the trial was a composite measure of all-cause mortality, heart attacks, or any unplanned interventions to restore heart blood flow within one year.
Results showed that both methods yielded comparable outcomes, with 6.9% of the FFRangio group experiencing a primary endpoint event, compared to 7.1% in the conventional wire-based group. Notably, the FFRangio technique proved faster to administer and required fewer procedural steps, avoiding the need for additional catheters and medications, as noted by Kirtane.
One limitation of the study is its non-blinded design, meaning that patients, clinicians, and independent evaluators were aware which method was used. Additionally, the study excluded patients with previous coronary artery bypass surgery or those who might require it, necessitating further investigation into the applicability of this approach for such patients.
Moving forward, Kirtane and his team plan to explore whether FFRangio can produce cost savings in comparison to traditional wire-based assessments, particularly in light of these trial findings.
The research received funding from CathWorks, Ltd., the developer of FFRangio. Dr. Kirtane disclosed institutional funding to Columbia University and Cardiovascular Research Foundation from CathWorks and Medtronic.
This study was simultaneously published online in the New England Journal of Medicine during the presentation.
Findings from another innovative method for estimating coronary pressure and flow, termed vesselFFR, will also be presented in the same session and press conference.
Kirtane is set to present the study titled “A Large-scale, Global Randomized Trial of Coronary Physiology Derived from Conventional Angiography Compared with an Invasive Pressure Wire-based Approach To Guide Percutaneous Coronary Intervention” on Sunday, March 29, at 8:30 a.m. CT / 13:30 UTC in the Main Tent, Great Hall.
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