TRANSFORM trial will harness AI to evaluate personalized heart disease care strategies
Click Here to Manage Email Alerts
Key takeaways:
- A randomized controlled trial will compare an AI-assisted strategy to stage coronary heart disease vs. usual care for preventing CV events.
- The trial will enroll adults at risk for but without a history of CVD.
PHILADELPHIA — A randomized controlled trial will assess whether pairing coronary CT angiography with an investigational AI algorithm to stage coronary plaque burden is superior to usual care for primary prevention of CV events.
For the TRANSFORM trial, researchers will compare whether adults at risk for but without a history of CVD are less likely to experience a CV event with a treatment strategy guided by coronary CT angiography paired with the plaque staging system (Cleerly Health) compared with coronary CT plus usual care, according to Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart, the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai and a member of the Healio | Cardiology Today Editorial Board.
Image: Adobe Stock
Bhatt announced details about the TRANSFORM trial during an innovation symposium at the American Heart Association Scientific Sessions.
“The idea is to assess whether staging coronary plaque actually improves outcomes,” Bhatt told Healio. “This trial will look at plaque progression and whether this algorithm is better than standard risk calculators. But the potentially practice-changing part of the trial is going to look at CV outcomes as well.”
Bhatt said the TRANSFORM trial will enroll approximately 7,500 patients across 100 to 200 sites in the U.S. with prediabetes, type 2 diabetes or metabolic syndrome but no symptoms or history of CVD. All participants will undergo coronary CT angiography; researchers will then assign participants to usual care — treatment based on ASCVD risk factors — or to treatment based on the plaque staging system using the Cleerly algorithm. Patients in the intervention arm will receive a CAD plaque stating report at baseline and at 24 months; results will also be provided to the central cardiologist-led team for discussion and care planning with the patient.
“The AI enabled algorithm incorporates data on plaque volume, burden and composition to calculate a patient’s risk, whether there is or isn’t ischemia, and essentially stage the plaque and calculate how high-risk the patient is,” Bhatt said during an interview. “Based on that stratification, clinicians will allocate patients to a strategy of medical therapy and then the patients undergo a repeat CT scan at 2 years looking for plaque progression. If it progresses, there will be further intensification of medical therapy. The control arm also gets a CT angiogram at baseline and 2 years but we will be blinded to that until the end of the trial.”
Cleerly is sponsoring the trial. Other industry sponsors will supply guideline-directed medical therapies for the study, including Agepha Pharma, which is providing colchicine 0.5 mg (Lodoco); Esperion Therapeutics, which is providing bempedoic acid and ezetimibe tablets (Nexlizet); Heartbeat Health, a virtual cardiology provider for the trial; and Lexicon Pharmaceuticals, which is providing sotagliflozin (Inpefa). The AHA will provide educational materials.
Bhatt is serving as the TRANSFORM study co-chair with David Maron, MD, clinical professor of medicine and director of preventive cardiology and of Stanford Prevention Research Center at Stanford University School of Medicine.
“This will be a multi-year trial, so it will be a while before we have the answer,” Bhatt told Healio. “However, it is exciting to finally test whether this type of imaging is in fact useful to guide therapy. This is what we need in the imaging and risk stratification world — evidence that these approaches make a difference in terms of patient outcomes.”
In a press release, Cleerly stated that trial recruitment is scheduled to close in late 2025 and results can be expected in late 2028.
“This will be exciting regardless of what the study shows,” Bhatt told Healio. “We were happy to launch it at the AHA.”
Collapse
Click Here to Manage Email Alerts