Deepak Bhatt, MD, MPH, MBA

Plaque Imaging and the TRANSFORM Trial in Myocardial Infarction

Acute coronary syndrome (ACS), and more specifically 

, 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.

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.

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.

“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 

. “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.

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.

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 

 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.

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.

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. 

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

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

Videos

Deepak Bhatt, MD, MPH, MBA, discusses his recent presentation at the ASPC 2026 Virtual Imaging Symposium and how plaque imaging can change the MI landscape.

Dr. Deepak Bhatt highlights 4 trials to watch in the late-breaking sessions at ACC.26.

ACC.26 Late-Breakers to Watch, With Deepak Bhatt, MD, MPH, MBA

As the cardiovascular community prepares to convene in New Orleans for the 

American College of Cardiology’s Annual Scientific Session & Expo (ACC.26)

, attention is once again turning to the late-breaking clinical trials expected to define the meeting’s scientific and clinical impact.

Each year, these presentations serve as a bellwether for where cardiovascular care is headed, often introducing data directly informs guideline updates, reshapes treatment algorithms, and accelerates adoption of emerging therapies across practice settings.

The momentum heading into ACC.26 follows a high-impact showing at ACC.25, where more than 50 late-breaking trials highlighted rapid advances across cardiometabolic care, lipid management, and interventional cardiology.

Notable data included the REVERSE-IT trial demonstrating rapid reversal of ticagrelor’s antiplatelet effects, the ALPACA study showing profound and sustained reductions in lipoprotein(a), and the ADVANCE-HTN trial evaluating novel approaches for treatment-resistant hypertension. These findings underscored a broader shift toward precision therapeutics, long-acting agents, and targeted mechanisms addressing previously unmet clinical needs.

Against this backdrop of accelerating innovation, ACC.26 is expected to build on these themes, with new data poised to further refine risk stratification, expand minimally invasive treatment strategies, and uncover novel drivers of cardiovascular disease. Increasingly, the field is moving toward earlier intervention and more individualized care, supported by advances in both pharmacologic and device-based therapies.

Presentation Title: Prevalence of Endogenous Hypercortisolism in Resistant Hypertension: Results of the MOMENTUM Trial
Presenter: Deepak L. Bhatt, MD, MPH, MBA
NCT06829537

MOMENTUM (NCT06829537), a prospective, multicenter observational study enrolling 1000 patients across 45 US sites, examines whether endogenous hypercortisolism (Cushing's syndrome) underlies treatment resistance in this population. Patients screening positive by dexamethasone suppression test (DST ≥1.8 µg/dL) undergo additional workup and adrenal imaging.

The design mirrors the CATALYST study, which found hypercortisolism in approximately 1 in 4 patients with difficult-to-control type 2 diabetes. Bhatt, a lead investigator and steering committee member, anticipates results will open new therapeutic pathways, potentially including cortisol-modulating agents, for patients whose hypertension remains poorly controlled on standard care.

2. HI-PEITHO (Boston Scientific / PERT Consortium)

Presentation Title: Higher-Risk Pulmonary Embolism Thrombolysis (HI-PEITHO): Primary Results
Presenter: Stavros Konstantinidis, MD, PhD
NCT04790370

HI-PEITHO is the first large-scale randomized controlled trial powered to determine whether ultrasound-facilitated, catheter-directed thrombolysis (USCDT) via the EKOS™ endovascular system plus anticoagulation improves outcomes versus anticoagulation alone in acute intermediate-high-risk pulmonary embolism (PE).

The 7-day primary composite endpoint includes PE-related death, cardiorespiratory decompensation or collapse, and non-fatal symptomatic PE recurrence. Enrolling 544 patients across 72 US and European hospitals, the adaptive-design trial addresses the longstanding gap left by the original PEITHO study, which demonstrated hemodynamic benefit of systemic thrombolysis at the cost of unacceptable hemorrhagic stroke rates. HI-PEITHO employs the validated National Early Warning Score (NEWS ≥9) to standardize decompensation criteria.

3. SURVIV Trial (Instituto Dante Pazzanese de Cardiologia, São Paulo)

Transcatheter Valve-in-Valve Versus Redo-Surgical Valve Replacement for Mitral Bioprosthetic Valve Dysfunction: Primary Results of the SURVIV Randomised Trial
Presenter: Dimytri A. Siqueira, MD, PhD

Bioprosthetic mitral valves inevitably undergo structural deterioration, yet the optimal reintervention strategy, transcatheter mitral valve-in-valve (mViV) via transseptal, balloon-expandable approach versus redo surgical mitral valve replacement (rMVR), has never been tested in a randomized trial.

SURVIV is a prospective, multicenter, open-label RCT enrolling 150 patients with mitral bioprosthetic valve dysfunction across multiple Brazilian centers, randomized 1:1 to mViV or rMVR. Bhatt, a co-investigator, noted the study could shift decision-making away from high-risk redo surgery toward a less invasive standard of care for this growing patient population, particularly as the prevalence of failed bioprostheses rises with longer patient lifespans and expanding valve repair programs.

4. IVUS-CHIP Trial (ECRI / Boston Scientific)

Presentation Title: Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures: Primary Results of the IVUS-CHIP Trial
Presenter: Roberto Diletti, PhD
NCT04854070

Despite accumulating evidence favoring intravascular ultrasound (IVUS) guidance over angiography alone in PCI, rigorous randomized data in patients specifically defined as complex and high-risk, the CHIP population, have remained limited.

IVUS-CHIP is a randomized, controlled, multicenter, post-marketing study enrolling 2,020 patients with complex coronary lesions across approximately 40 hospitals in 7 European countries, randomized 1:1 to IVUS-guided versus angiography-guided PCI with a minimum 2-year follow-up. The primary endpoint is target-lesion failure, which is defined as a composite of cardiac death, target-vessel MI, and clinically indicated target-lesion revascularization.

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

Bhatt DL. Key clinical trial insights from ACC 2025, with Deepak Bhatt, MD, MPH, MBA. 

. Published April 9, 2025. Accessed March 20, 2026. 

https://www.hcplive.com/view/key-clinical-trial-insights-from-acc-2025-with-deepak-bhatt-md-mph-mba-

Corcept Therapeutics. Corcept Therapeutics initiates MOMENTUM trial to determine prevalence of hypercortisolism in patients with resistant hypertension. 

. Published March 10, 2025. Accessed March 19, 2026. 

https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-initiates-momentum-trial-determine/

Skhirtladze-Dworschak K, Konstantinidis SV, Rosenfeld K, et al. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: rationale and design of the HI-PEITHO study. 

. 2026;S0002870326000013. doi:10.1016/j.ahj.2026.01.001. Accessed March 19, 2026.

Boston Scientific Corporation. The HI-PEITHO study. Boston Scientific website. Accessed March 19, 2026. 

https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/venous-thromboembolism-portal/pulmonary-embolism/clinical-data/hi-peitho.html

Siqueira DA, Abizaid AAC, Ramos AA, et al. Transcatheter valve-in-valve versus redo-surgical valve replacement for mitral bioprosthetic valve dysfunction: rationale and design of the SURVIV randomized trial. 

. Published online 2026. doi:10.4244/EIJ-D-25-01090. Accessed March 19, 2026.

Deepak Bhatt, MD, MPH, MBA, discusses 4 trials to watch at the upcoming ACC.26.

Key Clinical Trial Insights from ACC 2025 with Deepak Bhatt, MD, MPH, MBA​

Thousands of cardiovascular professionals from around the world converged in Chicago for the 

American College of Cardiology’s 2025 Annual Scientific Session (ACC.25)

, where cutting-edge science and clinical breakthroughs took center stage. With more than 4,750 abstracts accepted, 1,300 expert faculty, and 53 late-breaking clinical trials, the meeting delivered a high-impact snapshot of where cardiology is headed.

As a follow-up to our ACC.25 preview, our editorial team caught up with Deepak Bhatt, MD, MPH, MBA, director of Mount Sinai Heart and the Dr. Valentin Foster Professor of Cardiovascular Medicine at the Icahn School of Medicine, for his take on the most important data to emerge from the meeting. In this video interview, Dr. Bhatt breaks down three headline-grabbing studies (REVERSE-IT, ALPACA, and ADVANCE-HTN) and revisits the trials he flagged as ones to watch ahead of the conference (STRIDE, SOUL, and DapaTAVI).

Bentracimab, an investigational reversal agent for ticagrelor, rapidly restored clotting function in patients facing urgent surgery or major bleeding in the REVERSE-IT trial. Currently under FDA review, bentracimab could address a major clinical gap, as no approved reversal agent exists for ticagrelor.

The study’s primary endpoint—percent inhibition of P2Y12 Reaction Units (PRU)—dropped significantly within hours post-dose (

 < .0001), confirming rapid reversal. Results were consistent across surgery and bleeding groups, and across subgroups by age and sex.

Lepodisiran, a long-acting siRNA therapy, led to profound and sustained reductions in lipoprotein(a) [Lp(a)] levels for up to 18 months in the ALPACA trial. In the placebo-controlled study of 320 patients, those receiving two 400 mg lepodisiran doses experienced a 94.8% reduction in Lp(a) at 180 days, with levels still 74.2% lower at 1.5 years.

With no approved treatments available for elevated Lp(a)—a major cardiovascular risk factor—lepodisiran could represent a significant advance if long-term efficacy and safety are confirmed. Eli Lilly has initiated a Phase 3 clinical development program, ACCLAIM-Lp(a).

Lorundrostat significantly lowered blood pressure in patients with uncontrolled hypertension in the ADVANCE-HTN trial. The randomized, placebo-controlled trial included 285 patients already on 2 to 5 antihypertensive medications who still experienced elevated blood pressure.

At 12 weeks, patients receiving lorundrostat experienced greater reductions in 24-hour average systolic blood pressure (SBP) compared to placebo, with placebo-adjusted drops of -7.9 mmHg and -6.5 mmHg in the 50 mg and 50–100 mg dose groups, respectively. At week 4, patients on lorundrostat were also three times more likely to reach a 24-hour average SBP below 125 mmHg.

Oral semaglutide reduced major adverse cardiovascular events (MACE) by 14% over 4 years in high-risk patients with T2D in the SOUL trial. Among 9650 patients with ASCVD, CKD, or both, oral semaglutide lowered the composite rate, primarily driven by a 26% reduction in non-fatal heart attacks.

As the first trial to confirm cardiovascular benefit with an oral GLP-1, SOUL could offer a meaningful alternative for patients unwilling or unable to use injections. While gastrointestinal side effects were more common with oral semaglutide, serious adverse events were slightly less frequent than with placebo.

Semaglutide 1.0 mg (Ozempic) significantly improved functional outcomes in patients with peripheral artery disease (PAD) and type 2 diabetes (T2D) in the STRIDE trial. Over 52 weeks, patients receiving semaglutide experienced a 13% improvement in walking distance versus placebo (P = .0004), with improvements in pain-free walking distance, ankle-brachial index, and quality-of-life gains versus placebo.

STRIDE marked the first trial of a GLP-1 receptor agonist in PAD and could position semaglutide as the first therapy in over 20 years to improve PAD function.

Daily dapagliflozin reduced the risk of death or worsening heart failure by 28% at one year in patients undergoing transcatheter aortic valve implantation (TAVI) in the DapaTAVI trial. The benefit was driven by a 37% reduction in worsening heart failure, while all-cause mortality was numerically lower but not statistically significant.

Conducted across 39 centers in Spain, the study included a mostly elderly population, often excluded from prior SGLT2 trials. Dapagliflozin showed a favorable safety profile overall, although it was linked to higher rates of genital infections and hypotension.

Relevant disclosures for Bhatt include Amarin, AstraZeneca, Sanofi, Pfizer, Roche, Amgen, and Eli Lilly and Company, among others.

Deepak Bhatt, MD, MPH, MBA, explores high-impact trials from ACC.25, including REVERSE-IT, Alpaca, ADVANCE-HTN, SOUL, STRIDE, and DapaTAVI.

Key Clinical Trial Insights from ACC 2025, with Deepak Bhatt, MD, MPH, MBA​

Bentracimab in Phase 3 REVERSE-IT Trial with Deepak L. Bhatt, MD, MPH, MBA

Bentracimab, a novel drug designed to reverse ticagrelor’s antiplatelet effects, demonstrated rapid and sustained efficacy in the REVERSE-IT trial, according to data presented at the 

American College of Cardiology (ACC) 2025 Annual Scientific Sessions

The trial showed use of bentracimab restored normal blood clotting within minutes, making it a potential breakthrough for patients on ticagrelor requiring urgent surgery or experiencing major bleeding, according to lead investigator Deepak L. 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.

Developed by SFJ Pharmaceuticals and set for US commercialization by SERB Pharmaceuticals, bentracimab is under review by the US Food and Drug Administration (FDA) following submission of a Biologics License Application in August 2024. At the time of filing to the FDA, no reversal agent exists for ticagrelor, making bentracimab a promising candidate to fill this gap.

A multicenter, open-label study, REVERSE-IT evaluated bentracimab’s ability to reverse ticagrelor’s effects among 226 patients who received ticagrelor within the previous 3 days and either needed surgery or another invasive procedure that could not be delayed or were experiencing major bleeding.

The trial’s primary endpoint was platelet inhibition reduction, which showed a statistically significant decrease within 4 hours of administration (P < .0001). Hemostasis rates were 94.3% overall, with 100% in surgical patients and 83.1% in those with major bleeding.

Further analysis indicated 18% of surgical patients and 12% of bleeding patients experienced serious treatment-related adverse events, but none withdrew from the study due to these effects. Importantly, no allergic reactions were reported.

For more on the study and how it could precipitate change in management of these patients, check out our interview with Bhatt.

DL Bhatt. Bentracimab for Ticagrelor Reversal in Patients Undergoing Urgent Surgery – The Main Results Of The Phase 3 Reverse-it Trial. Presented at: American College of Cardiology (ACC.25) Annual Scientific Session. March 29 – 31, 2025. Chicago, Il.

Campbell P. Reverse-it: Bentracimab effective in reversing ticagrelor antiplatelet effects. HCP Live. March 29, 2025. Accessed March 29, 2025. https://www.hcplive.com/view/reverse-it-bentracimab-effective-in-reversing-ticagrelor-antiplatelet-effects.

Bhatt examines the potential reversal of the antiplatelet effects of ticagrelor with bentracimab in the REVERSE-IT trial.

Deepak Bhatt, MD, MPH, MBA

Articles