Friday, July 25, 2025

AI-Powered Coronary Plaque Analysis Enhances CCTA, Changes Care, and Cuts Long-Term Costs: Insights from the DECIDE Registry

Introduction

As artificial intelligence (AI) continues to transform cardiovascular diagnostics, its integration into coronary CT angiography (CCTA) is showing compelling promise. The DECIDE registry, presented at the 2025 Society of Cardiovascular Computed Tomography (SCCT) meeting, demonstrates that AI-based coronary plaque analysis (AI-CPA) can lead to meaningful changes in clinical management for over half of symptomatic patients—while simultaneously reducing long-term costs. This marks a significant step forward in personalized cardiovascular prevention and risk stratification.


AI-Driven Insights Go Beyond Stenosis Severity

The DECIDE registry assessed the clinical utility of AI-enabled plaque quantification using a commercial platform (HeartFlow) in 972 symptomatic patients undergoing CCTA. The analysis remained blinded until 90 days post-index CCTA, at which point clinicians were provided AI-derived plaque burden and staging (mild, moderate, severe, or extensive).

  • Primary finding: In 51.3% of patients, AI-CPA led to a change in medical management.

  • Treatment escalations occurred in 36%, including increased statin dosing or new lipid-lowering therapy.

  • Management changes were more frequent in patients with higher plaque burden, diabetes, hypertension, hyperlipidemia, and CT-FFR < 0.80.

This demonstrates how quantitative plaque analysis, independent of luminal stenosis, can recalibrate treatment intensity more effectively than risk calculators alone.


Better LDL Targeting and Lipid Control

In patients whose management changed, 44.1% started a new lipid-lowering agent, while 23.5% had dosage intensifications. Among those with serial cholesterol testing, significant improvements in LDL and HDL were observed only in patients who had management changes (P ≤ 0.01), reinforcing the downstream effect of AI-informed care on biomarkers and adherence.


Visualizing Disease for Patients and Providers

Physicians noted that AI-generated arterial images helped bridge the gap between diagnosis and behavior change, facilitating shared decision-making. Presenting visual evidence of coronary plaque, LDL targets, and personalized risk empowered patients to better understand their disease and adhere to medication.

“It simplifies the discussion into one or two sentences. Showing patients their actual arteries and plaque burden improves compliance,” one investigator noted.


Real-World Economic Value: $719 Saved Per Patient Over 10 Years

Using Medicare fee-for-service data from the FISH&CHIPS study, a cost-effectiveness model projected:

  • All-cause mortality reductions of 0.3% to 1.1% over 3.5 to 10 years.

  • Cost savings per patient of:

    • $263 at 3.5 years

    • $373 at 5 years

    • $719 at 10 years

These projections assume a one-time AI-CPA cost of $950 and account for downstream healthcare expenditures including PCI, ambulance transport, and inpatient care. Despite increased use of statins or PCSK9 inhibitors, the model suggests that upfront investments in AI-CPA are justified by lower event rates and hospitalizations.


Implications for Clinical Practice and Future Research

The DECIDE registry supports the growing sentiment that AI-augmented CCTA may soon redefine preventive cardiology. While long-term outcome trials are underway, the current findings suggest that quantifying coronary plaque offers actionable intelligence beyond traditional metrics.

"This isn’t just about plaque detection; it’s about precision therapy and early intervention," experts said. "We're witnessing the convergence of imaging and lipidology."


 


Key Takeaways for Busy Clinicians

  • AI-based coronary plaque analysis (AI-CPA) changed management in over 50% of symptomatic patients post-CCTA in the DECIDE registry.

  • Changes included new or intensified lipid-lowering therapies, which translated to better cholesterol control.

  • AI-CPA improved patient engagement and provided a visual tool to guide shared decisions.

  • Cost-modeling studies suggest $719 per patient savings over 10 years, despite the initial cost of AI analysis.

  • These findings support broader adoption of AI-enhanced plaque staging to guide personalized secondary prevention.


References

AI-Driven Coronary CT May Help Close Gaps in ASCVD Prevention, Especially for Women

 Introduction:

Despite decades of progress in the prevention of atherosclerotic cardiovascular disease (ASCVD), disparities persist—particularly in women. A promising innovation, AI-based quantitative computed tomography (AI-QCT), may offer a new solution. Recent results from the CERTAIN study, presented at the 2025 Society of Cardiovascular Computed Tomography (SCCT) meeting, suggest that AI-QCT may not only improve cardiovascular risk stratification but also influence therapeutic decision-making. However, a disconnect remains between AI-based recommendations and actual implementation in clinical practice.



How AI-QCT Is Reshaping Preventive Cardiology

AI-QCT, exemplified by platforms such as Cleerly, automates the quantification of coronary plaque burden from coronary CT angiography (CCTA). It stages plaque by total volume, helping identify high-risk patients earlier. In the CERTAIN study, 700 symptomatic patients from five US centers underwent AI-QCT, which generated personalized medication recommendations.

  • Plaque staging:

    • Stage 0: No plaque (1%)

    • Stage 1: 0–250 mm³ (61%)

    • Stage 2: 250–750 mm³ (28%)

    • Stage 3: >750 mm³ (10%)

Physicians were unblinded to AI findings, and 61.6% of patients received new preventive therapy recommendations, most often statins and aspirin.


Real-World Implementation Remains a Barrier

Despite clear AI-guided recommendations, only 29.7% of patients actually initiated new medications by 90 days. The gap was especially wide for:

  • Statins: Recommended for 30.1%, but only 7.7% filled prescriptions

  • Aspirin: Recommended for 35%, with just 4.7% filling them

Importantly, these gaps were consistent across all plaque stages, underlining a system-wide issue in translating risk stratification into treatment.


Persistent Gender Disparities

Although AI-QCT generated similar treatment recommendations for women and men (59.8% vs. 60.9%), women were less likely to receive prescriptions:

  • Prescription fill rate at 90 days:

    • Women: 25.8%

    • Men: 32.7% (P < 0.001)

  • Overall uptake of preventive therapies:

    • Women: 43.2%

    • Men: 53.8% (P = 0.031)

This suggests a persistent gender gap in cardiovascular care, possibly exacerbated by under-recognition of risk and suboptimal follow-through in clinical settings.


Future Directions and the Role of Patient Engagement

One major limitation of the CERTAIN study is that AI-QCT results were not shared with patients. The study investigators speculate that empowering patients with their own imaging data may enhance treatment adherence and shared decision-making.

Additionally, while AI-QCT shows great promise, standardization across vendors remains a challenge, as different software platforms may yield different plaque volumes. The TRANSFORM study, due to report in 2028, aims to validate how AI-driven tools translate into better clinical outcomes.



Key Takeaways for Clinicians:

  • AI-QCT shows promise in identifying patients at risk of ASCVD and guiding preventive therapy.

  • A significant gap remains between AI-guided recommendations and actual medication use, especially for statins and aspirin.

  • Women are less likely than men to receive prescribed preventive therapies, even when recommended by AI.

  • Patient engagement and standardization of plaque quantification across vendors are critical next steps.

  • Clinicians should consider using AI-QCT outputs in shared decision-making to enhance treatment adherence and outcomes.


Cardiac CT at 20 Years: From Doubt to Dominance, What’s Next?

 Introduction:

Two decades ago, cardiac computed tomography (CT) stood at the margins of cardiovascular imaging—dismissed by skeptics, mired in technical limitations, and often underestimated. Fast forward to 2025, and the field has not only matured but has transformed into a cornerstone of coronary artery disease assessment. At this year’s Society of Cardiovascular Computed Tomography (SCCT) meeting in Montreal, pioneers in the field gathered to commemorate this extraordinary journey—highlighting major achievements, ongoing challenges, and a future shaped by artificial intelligence, plaque characterization, and preventive cardiology.


A Diamond Formed Under Pressure

The early 2000s were marked by considerable skepticism toward cardiac CT. Doubts centered on radiation exposure, cost, accuracy, and the perceived lack of clinical impact. Yet as current SCCT leaders emphasized, the intense scrutiny only made the field stronger: “When you put enough pressure on carbon, it becomes a diamond.” That diamond began to shine with the release of landmark trials such as SCOT-HEART and PROMISE, which validated CT’s utility in diagnosing and managing coronary artery disease (CAD).

Cardiac CT's ability to noninvasively assess coronary anatomy, especially nonobstructive plaque, shifted paradigms in primary prevention and risk stratification, and opened the door to precision medicine in cardiovascular care.





From Niche to Norm: The SCCT’s Expanding Impact

Founded in 2005, the SCCT grew from a modest group of 200 to more than 6,000 members worldwide. This evolution was far from smooth. As past leaders recalled, the society faced “pushback from other imaging societies,” and technological barriers such as high radiation doses and limited spatial resolution. Radiologists and cardiologists were at odds, and false positives in early CT angiograms drew criticism from interventionalists and lipidologists alike.

Despite these hurdles, the field remained resilient, driven by a tight-knit community of innovators and early adopters. Founding members described their early involvement not as a calculated strategy, but as a pursuit of exciting scientific discovery. “We were challenged every step of the way—and I’m glad we were,” one said.


CT's Clinical Contributions and the AI Boom

In recent years, coronary CT angiography (CCTA) has evolved well beyond lumenography. Advanced tools now enable:

  • Plaque morphology and composition analysis

  • Quantitative plaque burden measurement

  • Functional assessments with CT-derived fractional flow reserve (FFR-CT)

  • Perivascular fat analysis and inflammation metrics

  • AI-enhanced image interpretation for improved workflow and diagnostic accuracy

These innovations have expanded the modality’s value from diagnosis to risk prediction, and now increasingly toward guiding therapy—particularly in patients with nonobstructive atherosclerosis, a group often missed by conventional stress testing.

Cardiac CT Image showing noncalcified plaque


Unanswered Questions and the Road Ahead

Despite the progress, several critical knowledge gaps persist. Experts noted that the prognostic value of CCTA remains under debate. While observational data suggest benefit, a randomized trial evaluating CT angiography in asymptomatic individuals—such as the ongoing SCOT-HEART 2 study—is needed to confirm whether early plaque detection improves outcomes.

Additional unanswered questions include:

  • Does plaque regression equate to event reduction?

  • Can AI models outperform traditional risk scores?

  • How should noncalcified plaque guide therapy in low-to-intermediate risk patients?

Current treatment trials such as EVAPORATE, HEARTS, and ARCHITECT aim to answer whether reducing plaque burden leads to fewer clinical events.


Charting a Transformative Future

The session’s panelists called for a rethinking of cardiovascular care. They emphasized that acute coronary syndromes should be viewed as preventable failures, not inevitable endpoints. Achieving this vision requires integrating early detection, aggressive risk modification, and personalized therapy—with cardiac CT playing a central role.

Speakers also highlighted the need to address sustainability, equitable access, and appropriate use criteria, along with the development of more effective AI-driven tools. These will define the next chapter in the evolution of cardiac CT.


Key Takeaways for Clinicians

  • Cardiac CT has evolved from a fringe tool to a mainstream modality backed by strong evidence from SCOT-HEART, PROMISE, and real-world practice.

  • The SCCT’s growth reflects the modality’s rising relevance in both diagnosis and prevention of CAD.

  • Ongoing challenges include the need for prospective outcome trials, better endpoint validation, and cost-effective implementation.

  • AI, plaque imaging, and functional CT tools are transforming CCTA into a prognostic and therapeutic guide.

  • Future directions emphasize prevention-first strategies, aiming to reduce events before they occur—with CCTA at the helm.


For further reading on the role of coronary CT in preventive cardiology and AI applications, visit the SCCT website and explore recent publications from JACC: Cardiovascular Imaging.

Even Clean Air Isn’t Risk-Free: Low-Level Air Pollution Tied to Coronary Atherosclerosis in Canada

Introduction
While smoggy skylines in industrial megacities dominate public discourse around air pollution, a new study from Canada suggests that even relatively low levels of particulate matter (PM2.5) are significantly associated with coronary artery calcium (CAC), plaque burden, and obstructive coronary artery disease (CAD). The findings, presented at the 2025 Society of Cardiovascular Computed Tomography (SCCT) meeting, challenge existing perceptions of what constitutes “safe” air quality and call for a re-evaluation of how we monitor and manage cardiovascular risk.





Pollution and Plaque: The Study at a Glance

Researchers from the University of Toronto conducted a retrospective analysis of 11,128 patients undergoing cardiac CT for suspected CAD across outpatient centers in Canada between 2014 and 2023. The median age was 59.1 years, with 51.7% of participants being men.

Participants were exposed to a median PM2.5 concentration of 7.5 µg/m³—below the World Health Organization (WHO) safety thresholds. Yet the results were revealing:

  • Every 1 µg/m³ increase in PM2.5 was associated with:

    • 10.7% higher CAC score

    • 12.5% greater odds of increased total coronary plaque

    • 22.6% higher odds of obstructive CAD (≥70% stenosis)


Source: American Heart Association

Sex-Specific Differences

The study found distinct gender-based effects:

  • In women, higher PM2.5 levels correlated with:

    • Elevated CAC scores

    • Increased risk of obstructive CAD

    • No significant change in total plaque burden

  • In men, higher PM2.5 levels were linked to:

    • Increased CAC scores

    • Elevated total plaque burden

    • No significant increase in obstructive CAD

These nuances highlight the importance of sex-stratified cardiovascular risk assessments in environmental health studies.


Why This Matters—Even in "Clean" Countries

Most study participants lived in areas with pollution levels considered "safe" by global standards. Still, they showed clear subclinical markers of atherosclerosis. This adds weight to recent calls by the World Health Organization to lower the annual safe limit of PM2.5 from 10 to 5 µg/m³.

Lead investigator Dr. Kate Hanneman emphasized the importance of this finding:

“We see the association at relatively low exposure levels. This is really important and distinct from areas like China where patients typically have much higher exposure levels.”


Implications for Clinical Practice

These findings suggest several key takeaways for clinicians:

  • Air pollution should be considered a modifiable cardiovascular risk factor, even at low ambient levels.

  • CAC scanning could be more widely utilized in individuals with occupational or residential exposure to pollution.

  • Sex-specific patterns of atherosclerosis progression warrant more individualized risk stratification.

Furthermore, these insights may catalyze public health action toward:

  • Improving air quality monitoring

  • Implementing urban planning to reduce exposure zones

  • Educating both patients and providers about environmental cardiovascular risk


Key Takeaways

  • Even low levels of air pollution (PM2.5 < 10 µg/m³) are associated with higher CAC, plaque burden, and obstructive CAD.

  • The association is sex-specific, affecting plaque burden in men and obstructive CAD in women.

  • These data challenge current “safe” pollution limits and suggest that environmental exposure should be integrated into cardiovascular risk assessments.

  • CAC scanning may be a useful tool for early detection in patients with chronic exposure to pollution.

Thursday, July 17, 2025

FDA Expands Finerenone Approval for Heart Failure Patients With Preserved Ejection Fraction

 In a significant development for heart failure (HF) treatment, the US Food and Drug Administration (FDA) has approved finerenone (Kerendia) for patients with mildly reduced or preserved left ventricular ejection fraction (LVEF ≥ 40%). This marks a major expansion of mineralocorticoid receptor antagonist (MRA)-based therapy beyond the traditional scope of patients with reduced ejection fraction.

Backed by FINEARTS-HF Trial Results

The FDA’s decision is grounded in the phase III FINEARTS-HF trial, which demonstrated that finerenone—a nonsteroidal MRA—significantly reduces the risk of cardiovascular death and worsening HF events compared to placebo. The trial focused on patients with LVEF ≥ 40%, a group historically underserved by MRA therapies.

Previous landmark studies such as RALES, EMPHASIS-HF, and TOPCAT had shown benefits for steroidal MRAs like spironolactone and eplerenone, but only in patients with LVEF < 40%. FINEARTS-HF now fills a critical gap by extending therapeutic options to a broader HF population.




Key Findings From the Trial

  • Primary Endpoint: Finerenone achieved a 16% relative risk reduction in cardiovascular death and total HF events.

  • Main Driver: The reduction was primarily due to fewer HF events.

  • Safety Profile:

    • Overall adverse event rates were similar between finerenone and placebo.

    • Higher incidence of hyperkalemia (9.7% vs 4.2%) and elevated creatinine (2.0% vs 1.2%) in the finerenone group.

  • No Interaction: The drug’s efficacy was consistent regardless of concurrent use of sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Impact on Patient Care

This approval is poised to benefit an estimated 3.7 million adults in the US living with HF and preserved or mildly reduced ejection fraction. With its proven efficacy and manageable safety profile, finerenone may become a cornerstone in the comprehensive management of HF in this population.

A Growing Role in Cardiovascular and Renal Health

Finerenone was previously approved in 2021 for patients with chronic kidney disease associated with type 2 diabetes, based on the FIGARO-DKD and FIDELIO-DKD trials. The latest FDA decision further solidifies its role in treating complex cardio-renal conditions.