Speaker
Pamela S. Douglas, MD, MACC, FASE, FAHA
Ursula Geller Professor of Research in Cardiovascular Diseases
Duke Clinical Research Institute – Duke University
Past President, American College of Cardiology
Past President, American Society of Echocardiography
Keywords
Chest Pain, Cardiovascular Imaging, Coronary Artery Disease
Key Points
- Imaging has transformed cardiology and many other fields. In 2024, despite several large randomized controlled trials (RCTs) comparing different evaluation approaches there is no universal consensus on initial imaging strategies, who to test and how; there are ongoing concerns about over imaging lowest risk patients but there is no consensus on testing deferral pathways; and new imaging technologies may offer value but are untested.
- Similar to most types of trials, there are pros and cons to both pragmatic and explanatory designs in imaging trials. Feasibility and generalizability affect design choices including inclusion/exclusion criteria, flexibility of imaging intervention being tested, guidance/control of subsequent care after imaging, and endpoints and outcomes.
- People with angina-like symptoms are often not patients with a disease. Most do not have obstructive coronary artery disease (CAD), but a few are very high risk. There is a potential for over testing with significant false positive rate and potential for missed diagnosis with stress imaging.
- RCT design will vary depending on which CAD manifestation(s) are reflected in the information provided by the imaging test being studied, which affects the treatment target(s) being evaluated in a therapeutic trial.
- There are many imaging findings that are important for optimal care. There is no single CAD phenotype that can be targeted diagnostically or therapeutically. Imaging strategies must be multidimensional or account for this heterogeneity.
- There are considerations for the flexibility of the intervention. When we evaluate imaging strategies for chest pain, is “usual testing” the appropriate comparator? Coronary CT angiography (CTA) may be the preferred test. Researchers also need to ask what is the optimal CTA intervention and should downstream care be required?
- What are appropriate endpoints for imaging RCTs and what events are we trying to avoid? Angina may not effectively discriminate between strategies. Intermediate endpoints such as diagnostic and therapeutic thinking are useful with impact on treatment being a major determinant of long-term value. Process of care/efficiency measures are important. Costs are rarely a significant factor in comparing different testing approaches.
Discussion Themes
-Why aren’t payors more willing to fund these trials? I have not seen a payor fund a trial in this space. There has only been a hand full of trials. They are trying to follow the guidelines for symptoms and disease. The tests are so common in aggregate it is a big expense.
–What is the sensitivity of portable AI ECHO devices? They are pretty good. We think about it as a screening tool to see if a patient needs an intervention.
Tags
#pctGR, @Collaboratory1