Plaque Imaging and the TRANSFORM Trial in Myocardial Infarction

Acute coronary syndrome (ACS), and more specifically myocardial infarction (MI), is among the most life-threatening diseases in the US, affecting roughly 1,045,000 patients annually. In addition to mortality, the condition contributes to a significant economic and health care burden.1

However, a significant proportion of patients with MI do not exhibit common identifiable risk factors, and many are not provided with the necessary therapies to forestall negative outcomes. Many patients are only treated after coming to the clinic with apparent symptoms, which naturally leaves many patients without treatment.2

At the American Society of Preventive Cardiology (ASPC) 2026 Virtual Imaging Symposium, Deepak Bhatt, MD, MPH, MBA, director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai, spoke on plaque progression and regression as an imaging endpoint for MI.2

“There’s been a tremendous amount of progress that’s been made in cardiology – we have terrific biological insight into what causes myocardial infarction, heart attacks,” Bhatt told HCPLive. “But about 1 in 5 patients don’t have any identified risk factors. Some of them maybe have risk factors, but they weren’t identified as such. About 1 in 5 didn’t have any prior physician visits, and a majority – about 2/3 – weren’t on any preventive therapies, though they should have been. That’s the state of primary prevention right now in the US – it’s not really effective.”

In his presentation, Bhatt addressed the limitations of current risk analysis for asymptomatic patients, highlighting a variety of potential methods of screening to catch ACS before it progresses. In addition to plaque analysis, Bhatt also highlights cholesterol, triglycerides, lipoprotein(a), and residual diabetes as red flags for ACS progression, proposing potential interventions for each.2

The leading pathological cause of ACS and, by extension, MI, is plaque rupture – several previous studies since 1980 have confirmed that plaque rupture is found in many of the most fatal MI cases. More recent decades have seen progress in utilizing imaging to identify precursor lesions that could progress to ACS, and investigators have hypothesized that local therapeutic interventions could prevent plaque rupture-induced thrombosis.1

Experts are currently investigating plaque screening methods in patients with MI through the TRANSFORM trial, which is a prospective, randomized, open-blinded endpoint (PROBE), event-driven, pragmatic trial in patients at increased risk of atherosclerotic cardiovascular disease without known symptomatic cardiovascular disease. The trial will implement the Cleerly Coronary Artery Disease (CAD) Staging System to identify asymptomatic patients and personalize treatment to avoid cardiovascular events.3

Bhatt expressed interest in the TRANSFORM trial, emphasizing the value of finding an effective method of screening for MI that will prevent the loss of traditionally asymptomatic patients. However, while Bhatt does support further screening tests in MI, he also addresses the inherent risks of implementing the technology early. Further testing is required to validate these devices and to determine their overall effectiveness.

“A lot of times, there can be a promising technology, and if you introduce it too soon, before there is the technical sophistication, the interpretive expertise, it doesn’t work,” Bhatt said. “The other risk is the Pandora’s box idea; that is, you don’t want to adapt a technology too soon, even though it’s intuitively appealing.”

Editors’ Note: Bhatt reports disclosures with GSK, Merck, Cereno Scientific, Angiowave, Boehringer Ingelheim, Novo Nordisk, and others.

References

1. Młynarska E, Czarnik W, Fularski P, Hajdys J, Majchrowicz G, Stabrawa M, Rysz J, Franczyk B. From Atherosclerotic Plaque to Myocardial Infarction-The Leading Cause of Coronary Artery Occlusion. Int J Mol Sci. 2024 Jul 2;25(13):7295. doi:10.3390/ijms25137295.

2. Bhatt D. Plaque Progression/Regression as a Treatment Target: Imaging Endpoints that Matter. Presented at the American Society of Preventive Cardiology 2026 Virtual Imaging Symposium, May 1, 2026. https://www.youtube.com/watch?v=t341F439OXI

3. Cleerly, Inc. A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events (TRANSFORM). ClinicalTrials.gov Identifier: NCT06112418. Updated May 20, 2026. Accessed May 20, 2026. https://clinicaltrials.gov/study/NCT06112418