Q&A with Dr. James Earls: New Clinical Research Shared at ACC.23/WCC

Cleerly attended the American College of Cardiology conference (ACC.23/WCC) to showcase our efforts in providing a safe and effective approach to understanding cardiovascular disease risk and guiding personalized treatment. Our team presented compelling clinical data in nine poster and oral abstract sessions that were well received by attendees, including study data about a proposed four-stage system for evaluating individual patient disease burden and our new AI-powered ischemia prediction algorithm for CCTA.

Why did Cleerly attend the American College of Cardiology conference (ACC.23/WCC)?

We were pleased to be part of this year’s conversation on the latest science and innovation as well as practice-changing updates advancing cardiovascular care. The prevalence of cardiovascular disease (CAD) is on the rise. Cleerly is a company focused on preventing heart attacks, so we see ACC as an opportunity to showcase our efforts underway to provide a safe, accurate, and effective approach to understanding disease risk and guiding personalized treatment.

What new clinical evidence did Cleerly share?

Our team presented compelling clinical data in nine poster and oral abstract sessions that were well received by attendees.

1. Plaque Staging System Predicts Long-Term (10-yr) MACE Events. One of our sessions focused on data from our ‘Quantitative Plaque Staging System Predicts Long-Term Cardiovascular Outcomes in Patients at Risk for Atherosclerotic Cardiovascular Disease’ study.¹ This is a timely study that follows the release of a paper in the Journal of Cardiovascular Computed Tomography about a proposed four-stage system for evaluating individual patient disease burden of atherosclerotic plaque by their plaque volume. Similar to staging systems used for oncology, this system offers defined stages as normal (no plaque), mild, moderate, and severe plaque. In this abstract, the 4 stages were shown to be prognostic over a 10-year follow-up period; the increasing stage demonstrated increased MACE events, and they were more prognostic than clinical risk scoring or calcium scoring-based systems.
2. New Investigational ISCHEMIA Algorithm Superior to SPECT for Predicting Invasive FFR. Another session provided early data from the ‘High Diagnostic Accuracy of AI-Ischemia in Comparison to PET, FFR-CT, SPECT, and Invasive FFR² study about our new atherosclerosis imaging-ischemia algorithm for CCTA, currently in development and not-FDA approved for clinical use. Based on the post-hoc analysis of the independent PACIFIC Study, we were able to show that when used in combination with quantitative plaque analysis, AI-Ischemia enables an accurate and comprehensive assessment of both atherosclerosis and ischemia by CCTA. The performance of the Ischemia prediction algorithm was superior to SPECT and statistically similar to both PET and FFR-CT for prediction of an invasive FFR.
3. Other studies looked at the comparison of plaque characteristics and distribution identified by CCTA across different populations,³ ethnicities,⁴ and conditions like diabetes,⁵ the prevalence and characteristics of plaque among firefighters,⁶ inflammatory markers associated with low-density plaque volume,⁷ as well as the accuracy of Cleerly’s approach to other methods for diagnosis of obstructive CAD.⁸

Your team also shared details on new treatment algorithms for atherosclerosis. Why are these significant?

Quantification of CAD burden and atherosclerotic plaque type is the strongest determinant of future risk of major adverse cardiac events. The new proposed treatment algorithms,⁹ outlined by the Innovations in Prevention Working Group of the American College of Cardiology, provide personalized recommendations for medical interventions based on the combination of CCTA quantification of atherosclerotic plaque burden and traditional cardiovascular risk factors from existing clinical guidelines.

What’s next for Cleerly?

It was helpful for us to engage and learn from industry-leading clinicians and researchers who are advancing cardiovascular care. Based on our interactions and insights gleaned from conversations at the conference, we believe it is imperative we continue our efforts to educate providers and individuals on the value of quantitative plaque analysis for understanding heart disease risk. A better understanding of this risk can enhance clinical decision-making, help providers avoid unnecessary and high-cost procedures, as well as improve the patient and provider experience.

We invite readers to connect with Cleerly to learn more about the science powering our approach to whole-heart evaluation.

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References

1. Quantitative Plaque Staging System Predicts Long-Term Cardiovascular Outcomes in Patients At Risk for Atherosclerotic Cardiovascular Disease. Journal of the American College of Cardiology. March 2023.
2. High Diagnostic Accuracy of AI-Ischemia in Comparison to PET, FFR-CT, SPECT, and Invasive FFR: A Pacific Sub Study. Journal of the American College of Cardiology. March 2023
3. Comparison of Coronary Plaque Characteristics in Younger South Asian and Non-Hispanic White Populations Utilizing CCTA: A Matched Cohort Study. Journal of the American College of Cardiology. March 2023.
4. Race/Ethnic Differences in Coronary Atherosclerotic Plaque Assessed on Cardiac Computed Tomography Angiography (CCTA) In an Asymptomatic United States Population: Results from the Miami Heart Study. Journal of the American College of Cardiology. March 2023.
5. Distribution of Coronary Atherosclerosis in Patients with Diabetes Mellitus, Using Quantitative CT Plaque Analysis: Results from the Miami Heart Study. Journal of the American College of Cardiology. March 2023.
6. Firefighters Coronary Plaque Prevalence and Characteristics in Comparison to Non-Firefighters. Journal of the American College of Cardiology. March 2023.
7. Elevated LP(a) and Inflammatory Markers Are Associated with Increased Low-Density Plaque Volume, Which May Explain Increased ASCVD Risk. Journal of the American College of Cardiology. March 2023.
8. AI-QCT Demonstrates Superior Accuracy for the Diagnosis of Obstructive CAD by QCA Standard Compared to Core Lab CCTA Interpretation. Journal of the American College of Cardiology. March 2023.
9. Integrating Coronary Atherosclerosis Burden and Progression with Coronary Artery Disease Risk Factors to Guide Therapeutic Decision Making. The American Journal of Medicine. March 2023.