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.

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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.

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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.

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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.

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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.

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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."

 

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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.

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References

• HeartFlow AI-Powered Coronary Plaque Analysis

• DECIDE Registry Overview

• TCTMD Conference Coverage

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.”

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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

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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.

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.

Challenging Aspirin’s Reign: P2Y12 Inhibitors Offer Safer Long-Term Option Post-PCI

 Introduction

For decades, aspirin monotherapy has been the go-to agent for long-term secondary prevention after percutaneous coronary intervention (PCI). But emerging evidence is turning this dogma on its head. A new meta-analysis involving over 16,000 patients suggests that P2Y12 inhibitors—such as clopidogrel and ticagrelor—may offer superior protection against major cardiovascular events with no added risk of major bleeding. These findings mark a potential paradigm shift in antiplatelet strategy and call into question aspirin’s primacy in the chronic management of post-PCI patients.

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The Study: A Meta-Analysis Across Five RCTs
Published in BMJ, the study pooled patient-level data from five randomized controlled trials—ASCET, CAPRIE, GLASSY, HOST-EXAM, and STOPDAPT-2—to compare the outcomes of P2Y12 inhibitor monotherapy vs aspirin monotherapy after patients had completed ~12 months of dual antiplatelet therapy (DAPT).

• Population: 16,117 patients (mean age 65; 23.8% women; 55.5% with ACS)

• Follow-up: Median 5.5 years (1,351 days)

• P2Y12 agents used: 58.7% clopidogrel, 41.3% ticagrelor

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Key Results

✅ Lower MACCE:

• P2Y12: 1.49 events/100 person-years

• Aspirin: 1.93 events/100 person-years

• Hazard Ratio (HR): 0.77 (95% CI: 0.67–0.89)

• Number Needed to Treat (NNT): 45.5

✅ No difference in major bleeding:

• Both groups had 0.70 events/100 person-years

✅ Reduced net adverse cardiovascular and cerebrovascular events with P2Y12 inhibitor monotherapy (HR: 0.86)

📉 Lower ischemic stroke rates and numerically lower stent thrombosis rates with P2Y12 inhibitors

⚠️ Bleeding:

• Slight increase in overall and GI bleeding with P2Y12 inhibitors, but major bleeding rates were identical

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Clinical Implications: A New Equal for Aspirin?

Experts argue that P2Y12 inhibitors, particularly clopidogrel, should be viewed as a viable, possibly preferable, long-term option post-PCI:

• Equivalent or superior efficacy

• Comparable safety in terms of major bleeding

• Particularly attractive for patients not undergoing planned surgery

“A preference towards aspirin monotherapy as the only option for a class I recommendation is probably now not entirely supported by the data.”
— Marco Valgimigli, MD, PhD

However, cost and clopidogrel resistance remain concerns. While clopidogrel is more expensive than aspirin, the long-term savings from reduced MIs and strokes may offset the upfront drug costs. Concerns about clopidogrel resistance may be less relevant in the chronic phase post-PCI, where bleeding risk becomes a more persistent issue than thrombotic risk.

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Limitations and Future Directions
Editorialists rightly caution that these are “medium-term” findings. Randomized trials with longer follow-up are needed, especially in elderly patients. The durability of ischemic protection and safety beyond five years remains uncertain.

Ongoing trials such as STOPDAPT-3 and SMART CHOICE-3 aim to clarify the role of clinical predictors in clopidogrel responsiveness and long-term safety.

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Key Takeaways for Clinicians

• P2Y12 inhibitor monotherapy is a safe and effective long-term alternative to aspirin following PCI.

• Offers a 33% relative reduction in MACCE without increasing major bleeding.

• Long-standing clinical inertia favoring aspirin should be reevaluated in light of this evidence.

• Decision-making should consider patient phenotype, surgical plans, and drug costs.

• Future studies must explore the lifetime impact of different monotherapy strategies and possibly aspirin-free secondary prevention.

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References

• BMJ Meta-analysis – Giacoppo et al., 2025

• CAPRIE Trial

• HOST-EXAM Trial

• SMART-CHOICE Trial

FDA Greenlights First Triple-Drug Polypill for Hypertension: A Simpler, Smarter Start to Blood Pressure Control

 Introduction:

In a landmark advancement for cardiovascular care, the US Food and Drug Administration (FDA) has approved Widaplik, the nation’s first triple-combination polypill for initial treatment of hypertension. This once-daily tablet unites three proven classes of blood pressure medications—telmisartan, amlodipine, and indapamide—into a fixed-dose therapy designed to simplify care, enhance adherence, and improve outcomes for the millions living with uncontrolled blood pressure.

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A New Era for Hypertension Management

Hypertension, affecting over 122 million US adults and 1.2 billion people globally, remains one of the most prevalent and undertreated risk factors for stroke, heart attack, heart failure, and kidney disease. Despite the availability of effective treatments, adherence to complex drug regimens has posed a significant barrier to long-term control.

Widaplik’s approval signals a paradigm shift toward simplified treatment pathways, particularly for patients likely to require multiple agents to reach blood pressure targets from the outset.

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What's Inside Widaplik?

The fixed-dose triple therapy polypill contains:

• Telmisartan (ARB): Blocks angiotensin II receptors, reducing vasoconstriction and aldosterone-mediated volume retention.

• Amlodipine (CCB): Inhibits calcium influx in vascular smooth muscle, promoting vasodilation.

• Indapamide (thiazide-like diuretic): Reduces blood volume and peripheral resistance via mild diuresis.

Available in standard and two lower dosages, Widaplik is engineered for flexibility while maximizing efficacy.

The FDA approved Widaplik in three fixed-dose strengths to accommodate different patient profiles:

1. Telmisartan 40 mg / Amlodipine 5 mg / Indapamide 1.25 mg

2. Telmisartan 20 mg / Amlodipine 2.5 mg / Indapamide 0.625 mg

3. Telmisartan 20 mg / Amlodipine 5 mg / Indapamide 1.25 mg

⚠️ Important: Telmisartan is contraindicated during pregnancy, as it can cause fetal toxicity. Widaplik should be discontinued immediately if pregnancy is detected.

 

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Evidence Behind the Approval

Widaplik’s approval is backed by two clinical trials:

1. Placebo-Controlled Study: Demonstrated significant reductions in blood pressure when used as an initial therapy in hypertensive patients.

2. Active Comparator Trial: Showed superior efficacy of the triple-drug polypill over dual-drug combinations of the same agents.

These findings align with a 2023 meta-analysis reporting that triple or quadruple low-dose polypills consistently outperform monotherapy or usual care in lowering blood pressure and improving adherence.

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Why This Matters: Clinical and Global Implications

• Improved adherence: Fewer pills mean better long-term compliance, especially in populations with limited access to healthcare.

• Guideline evolution: Though most current hypertension guidelines still favor starting with one or two agents, fixed-dose combination therapies like Widaplik offer streamlined initiation.

• Global priority: In support of WHO goals to reduce hypertension prevalence by 33% by 2030, fixed-dose polypills may become a cornerstone in low- and middle-income countries, where treatment gaps are largest.

Even though the WHO’s essential medicine list includes polypills combining antihypertensives with statins and aspirin, Widaplik’s approval may pave the way for broader use of hypertension-specific fixed-dose therapies in both primary and secondary prevention.

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What’s Next?

George Medicines, the manufacturer of Widaplik (previously known as GMRx2), plans a commercial launch later in 2025. With its cost-effective design and evidence-based structure, Widaplik is poised to become a first-line option for initiating therapy in patients who need fast, efficient, and durable blood pressure control.

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Key Takeaways for Clinicians:

• Widaplik is the first FDA-approved triple-drug polypill (telmisartan/amlodipine/indapamide) for initial treatment of hypertension.

• Shown to be more effective than dual combinations or placebo in clinical trials.

• Simplifies therapy and improves adherence, especially important in patients needing multiple drugs from the outset.

• Offers a practical tool to help meet global and national hypertension control targets.

• Must be avoided in pregnant patients due to teratogenic risks from ARB.

FDA Approves Tendyne TMVR System for High-Risk Patients with Complex Mitral Valve Disease

Introduction

In a major regulatory milestone, the US Food and Drug Administration (FDA) has approved Tendyne, a transcatheter mitral valve replacement (TMVR) system developed by Abbott, for use in a carefully selected subset of high-risk patients with mitral valve disease. This landmark approval addresses a longstanding therapeutic gap for patients who are unsuitable for surgery and have anatomies unfavorable for transcatheter edge-to-edge repair (TEER).

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Tendyne: A New Option for a Difficult Population

The Tendyne system is now FDA-approved for patients with:

• Moderate-to-severe mitral regurgitation (MR)

• Severe mitral stenosis

• Moderate MR with moderate-or-greater mitral stenosis due to mitral annular calcification (MAC)

Importantly, these patients must be ineligible for surgery and have anatomy not suitable for TEER—a profile that has previously left clinicians with limited options.

The approval is supported by data from the SUMMIT trial, which evaluated outcomes in patients either randomized to Tendyne or to MitraClip-based TEER. The trial cohort notably included patients with extensive MAC, a calcific burden that renders traditional surgical and transcatheter repair approaches highly risky or technically infeasible.

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Why This Matters: The Clinical Challenge of MAC

Mitral annular calcification (MAC) significantly compromises the flexibility and function of the mitral annulus, leading to a complex spectrum of MR, stenosis, or mixed pathology. Patients with MAC are frequently elderly with multiple comorbidities, making them poor surgical candidates. As Dr. Paul Sorajja noted in the Abbott press release, “Many are considered too high risk for open-heart surgery.”

Until now, these patients had limited access to definitive therapy. TEER, while beneficial in many cases, requires favorable anatomy—something MAC often precludes due to leaflet rigidity and calcific extension.

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Guidelines: Bridging the Gap Between Evidence and Practice

• European Guidelines (ESC/EACTS 2021):

  • Primary MR: Surgical repair is the gold standard unless risk is prohibitive (Class I, Level B).

  • TEER: Considered for inoperable patients with suitable anatomy (Class IIb, Level B).

  • TMVR: May be considered in exceptional cases when neither surgery nor TEER is possible (Class IIb, Level C).

• US Guidelines (ACC/AHA 2020):

  • TEER: Reasonable for high/prohibitive risk patients with primary MR (Class IIa, Level B).

  • For secondary MR, TEER also has a Class IIa, Level B recommendation in selected symptomatic patients.

  • TMVR: Until now, it lacked formal guidance due to the absence of FDA approval.

With this new approval, Tendyne may soon be incorporated into future updates of the US guidelines, offering a lifesaving pathway for patients once considered beyond the reach of effective therapy.

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Global Context: Europe Leading the Way

Europe approved Tendyne five years earlier, based on the Tendyne Global Feasibility Study, allowing for real-world experience to accumulate in complex patients. The US approval will now enable similar progress domestically, offering physicians an expanded interventional toolkit.

Obicetrapib: A Promising CETP Inhibitor for LDL and Lp(a) Reduction

Introduction

Obicetrapib, a cholesteryl ester transfer protein (CETP) inhibitor developed by NewAmsterdam Pharma, has emerged as a promising lipid-lowering therapy. Unlike previous CETP inhibitors like anacetrapib, evacetrapib, torcetrapib, and dalcetrapib, which failed due to safety concerns, obicetrapib has shown impressive results in the BROADWAY and TANDEM trials. These studies, presented at the 2025 European Atherosclerosis Society Congress and published in the New England Journal of Medicine and The Lancet, highlight the potential of obicetrapib as a novel oral agent for managing low-density lipoprotein (LDL) and lipoprotein(a) [Lp(a)] in high-risk patients.

Background on CETP Inhibitors
CETP inhibitors have long been explored as a therapeutic option for cardiovascular disease, initially aiming to raise high-density lipoprotein (HDL) levels. However, this approach fell out of favor as studies like the ILLUMINATE trial demonstrated increased cardiovascular events and mortality with torcetrapib. The failure of earlier CETP inhibitors shifted the focus toward LDL reduction, which has proven to be a more effective strategy for reducing major adverse cardiovascular events (MACE).

BROADWAY Trial Findings
The BROADWAY trial enrolled 2,530 patients with heterozygous familial hypercholesterolemia (FH) or atherosclerotic cardiovascular disease (ASCVD) who were already on maximally tolerated lipid-lowering therapy. Key results include:

• LDL Reduction: A 29.9% reduction in LDL at day 84 versus a 2.7% increase in the placebo group (P < 0.001). This effect was maintained through 1 year.

• Lp(a) Reduction: A 33.5% reduction in Lp(a) levels, highlighting its potential as a dual-action lipid-lowering therapy.

• Adverse Events: Comparable overall adverse event rates between obicetrapib (59.7%) and placebo (60.8%), with low rates of liver-enzyme (0.6%) and muscle enzyme (0.3%) abnormalities.

TANDEM Trial Findings
The TANDEM trial further tested obicetrapib in 407 patients with heterozygous FH or ASCVD, including those at high risk but not on statins. Key results include:

• Combination Therapy: Fixed-dose combination with ezetimibe achieved a 48.6% LDL reduction compared to placebo, a 27.9% reduction compared to ezetimibe monotherapy, and a 16.8% reduction compared to obicetrapib monotherapy.

• Adverse Events: Low rates of serious adverse events (3-7%) across all study arms, reinforcing the safety profile seen in BROADWAY.

Clinical Implications and Future Directions
The promising results from the BROADWAY and TANDEM trials position obicetrapib as a potentially important addition to the lipid-lowering toolkit. The PREVAIL study, expected to report outcomes in 2026, will be crucial for determining the long-term cardiovascular benefits of this agent. If successful, obicetrapib could fill a critical gap for patients with elevated LDL and Lp(a) levels who may not qualify for existing injectable therapies.

Key Takeaways

• Obicetrapib offers significant reductions in both LDL and Lp(a), addressing a critical need in lipid management.

• Safety profile appears favorable, with low rates of serious adverse events.

• The upcoming PREVAIL trial will provide crucial long-term efficacy data.

Conclusion
Obicetrapib represents a promising step forward in lipid management, potentially providing clinicians and patients with a novel oral option for comprehensive cholesterol control. With further validation, it could become a mainstay in the management of ASCVD and heterozygous FH.

Benefits of SGLT2 Inhibitors for Heart Failure: Real-World Evidence from a Large French Cohort Study

 Introduction

Heart failure (HF) remains a leading cause of morbidity and mortality worldwide, imposing a significant burden on healthcare systems and affecting millions of patients. In recent years, sodium-glucose cotransporter 2 (SGLT2) inhibitors have emerged as a cornerstone in the treatment of HF, offering benefits beyond their original use in type 2 diabetes management. A recent, large-scale, real-world study conducted in France provides robust evidence supporting the efficacy of SGLT2 inhibitors in improving outcomes for heart failure patients, reinforcing the urgency of early initiation in clinical practice.

Study Overview and Key Findings
The study, published in the May 2025 issue of JACC: Heart Failure, analyzed data from the French National Health Data System, which covers more than 99% of the population. The study included 191,357 adults with a recent HF hospitalization between 2021 and 2023, excluding those with prior exposure to SGLT2 inhibitors or early mortality/readmission within 30 days of discharge. Key findings include:

• Reduced All-Cause Mortality and HF Hospitalization: Patients who initiated SGLT2 inhibitors had a significantly lower risk of all-cause death or HF hospitalization (HR 0.71; 95% CI 0.67-0.75).

• Rapid and Sustained Benefits: Benefits were evident as early as 18 days after initiation, with continued advantage over a mean follow-up of 9 months.

• Consistent Efficacy Across Subgroups: The effects were consistent regardless of age, sex, diabetes status, LVEF, or type of SGLT2 inhibitor used.

• Increased Uptake Over Time: SGLT2 inhibitor use within 30 days of discharge increased from 5.1% in 2021 to 35.0% in 2023, highlighting growing clinical acceptance.

• Early Initiation is Critical: Patients initiating treatment had a lower median age (76 vs 84 years), were more likely to be male (61.5% vs 45.7%), and had more frequent comorbidities like diabetes and reduced LVEF.

Clinical Implications and Urgency
The findings underscore the critical need to initiate guideline-directed medical therapy (GDMT) early in the management of HF. Delays in SGLT2 inhibitor initiation expose patients to unnecessary clinical risks, as highlighted by Stephen Greene, MD (Duke Clinical Research Institute). The rapid benefits observed in this study further reinforce the need for aggressive, proactive HF management, comparable to the urgency seen in oncology care.

Key Takeaways for Clinicians

1. Early Initiation Saves Lives: SGLT2 inhibitors reduce all-cause mortality and HF hospitalization risk significantly.

2. Rapid Impact: Benefits can emerge within days, reinforcing the need for prompt therapy.

3. Broad Patient Benefit: Efficacy is consistent across diverse patient groups, including those with advanced age and multiple comorbidities.

4. Rising Uptake: Increased use reflects growing awareness, but gaps remain in real-world practice.

5. Urgency in HF Management: Treat HF with the same urgency as other life-threatening conditions.

Early Cardiogenic Shock: Underrecognized and Often Undertreated

 Introduction 

Early cardiogenic shock (CS) remains a significant clinical challenge, often leading to poor outcomes if not identified and managed promptly. Despite its severe implications, it is frequently underrecognized, with only one in four patients having any electronic medical record (EMR) documentation indicating their shock status. These findings were highlighted in a multicenter study presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2025 Scientific Sessions in Washington, DC. This article summarizes the critical insights from this study and their implications for clinical practice.

SCAI SHOCK Classification and Study Design The SCAI SHOCK classification system, widely adopted for staging cardiogenic shock, includes five stages:

• A (At Risk) – Patients with a potential risk of shock

• B (Beginning) – Patients with isolated hypotension or hypoperfusion

• C (Classic) – Patients with clear evidence of shock

• D (Deteriorating) – Patients with worsening shock

• E (Extremis) – Patients in severe, life-threatening shock

The study included 500 patients admitted to six hospitals within the Brown University Health System between 2017 and 2022. It specifically focused on patients in SCAI Stage B shock, characterized by isolated hypotension or hypoperfusion.

Key Findings: Poor Outcomes in Early Shock Patients in Stage B shock had concerning outcomes, with approximately 25% requiring transfer to a higher level of care, deteriorating to a more severe shock stage, or dying during hospitalization. The median time to this primary endpoint was 16 hours. Importantly, those with poorer outcomes had a median duration of 11 hours in SCAI B shock compared to 5 hours in those with favorable outcomes, defined as survival without shock stage escalation or transfer for higher care.

Predictors of Poor Outcome Several factors were identified as predictors of poor outcomes in SCAI B shock:

• Acute Kidney Injury (AKI) – Strongly correlated with poor outcomes, particularly when present in more advanced stages.

• Diuretic Resistance – Indicated a failing cardiorenal response.

• Oliguria – Decreased urine output in the prior 24 hours was a significant warning sign.

In-hospital mortality rates were notably higher among those with hypotension (15.4%) compared to those with hypoperfusion (9.5%). Deterioration to a higher shock class occurred in 36.3% of those with hypotension, versus 11.8% with hypoperfusion.

Importance of Early Detection and Response The study's lead author emphasized the need for enhanced education across disciplines, including emergency department staff and emergency medical services (EMS), to recognize early cardiogenic shock. Dr. Vallabhajosyula also suggested that smart EMR-based detection tools, similar to those used for sepsis, could significantly improve early recognition and intervention.

Future Directions Improving early detection and documentation of SCAI Stage B shock should be a research priority. Additionally, better understanding the cardiorenal implications of early cardiogenic shock could guide more effective management strategies.

Key Takeaways for Clinicians

• Early Identification is Critical: Recognizing Stage B shock early can significantly alter patient outcomes.

• Monitor for Key Predictors: Watch for AKI, diuretic resistance, and oliguria as critical early indicators of poor prognosis.

• Implement Detection Tools: Consider integrating EMR sniffers to improve early shock recognition.

• Cross-Disciplinary Training Needed: Educate ED and EMS personnel to enhance early shock detection.

Conclusion Early cardiogenic shock presents a high-risk scenario, even in patients with isolated hypotension or hypoperfusion. Proactive detection and timely intervention are essential to improve outcomes, highlighting the need for system-wide awareness and advanced predictive tools.

Pulsed-Field Ablation for Atrial Fibrillation: Promising, But Not Without Risk

 Introduction

Pulsed-field ablation (PFA) has rapidly emerged as a novel technique for the treatment of atrial fibrillation (AF), offering the potential for tissue-specific ablation with fewer catastrophic complications than traditional thermal methods. However, new data presented at Heart Rhythm 2025 raises concerns about subclinical injury, cerebral embolism, and coronary complications, challenging the narrative that PFA is the “perfect” solution. As the electrophysiology (EP) community embraces this innovation, a deeper understanding of its safety profile is critical.

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Safety Signals from the NEMESIS-PFA Registry

The NEMESIS-PFA registry (n=871) compared PFA to radiofrequency ablation (RFA) and identified significantly greater increases in biomarkers of myocardial injury, hemolysis, and renal stress in PFA-treated patients.

• Cardiac biomarkers like troponin rose substantially higher post-PFA (median: 13,551 vs 128 ng/dL).

• Indicators of hemolysis—including LDH, haptoglobin, and free hemoglobin—also rose, suggesting red blood cell destruction.

• Creatinine levels increased more in the PFA group, raising concerns about acute kidney injury.

• Left atrial ejection fraction (LAEF) dropped more sharply (20% vs 5%), indicating transient atrial dysfunction.

These findings suggest that although PFA avoids esophageal and phrenic nerve injury, it may induce other systemic effects with unclear long-term significance. The biophysical characteristics of PFA catheters—such as electrode geometry, pulse parameters, and electric field strength—likely influence these effects.

🔗 NEMESIS-PFA registry results in JACC: Clinical Electrophysiology

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Asymptomatic Cerebral Emboli (ACE): PEACE-AF Findings

In the PEACE-AF study, brain MRI within 72 hours post-PFA revealed asymptomatic cerebral emboli (ACE) in 34% of patients.

• Older age and persistent AF were associated with increased ACE risk.

• No clinical stroke or TIA occurred, but long-term neurological outcomes are pending.

While ACE is not unique to PFA, its incidence and potential cognitive implications merit further investigation and systematic surveillance in future trials.

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Coronary Complications: Mild but Present

A third study assessed PFA near coronary arteries during cavotricuspid isthmus (CTI) or mitral isthmus ablation. Despite using intracoronary nitroglycerin, 47% of patients developed severe coronary spasm (>70% narrowing).

• OCT at 3 months showed luminal narrowing and vascular wall thickening, indicating mild coronary stenosis.

• No patients developed angina or required revascularization, but the data signal a need for vigilance, especially in catheter-specific contexts.

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PFA: Still an Evolutionary Technology

Despite these findings, PFA maintains several clear advantages:

• It avoids atrioesophageal fistula, a rare but often fatal complication of thermal ablation.

• It is faster, reducing procedure and left atrial dwell time.

• Some data suggest superior efficacy for rhythm control in select populations.

Ongoing device innovations include dual-mode catheters (e.g., Medtronic’s Sphere-9, capable of both PFA and RFA), which may allow tailored energy delivery based on anatomy and risk.

🔗 Medtronic Sphere-9 and Affera system

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Expert Perspectives: Caution Over Hype

Experts agree that PFA is a step forward, but not the panacea it's sometimes marketed to be:

• “We’ve traded one set of major problems for another set of possibly less dire but still significant issues,” said electrophysiologist Dhanunjaya Lakkireddy.

• “All EPs should understand that PFA is not universally safe, and safety varies by system design,” said Wilber Su.

• A special issue of Pacing and Clinical Electrophysiology on PFA fundamentals is expected to help standardize operator understanding.

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Key Takeaways for Clinicians

• PFA reduces catastrophic risks like atrioesophageal fistula, but introduces concerns related to myocardial injury, hemolysis, renal dysfunction, and cerebral emboli.

• Biomarker elevations and drop in atrial function post-PFA highlight a need for longitudinal safety surveillance.

• ACE incidence post-PFA (34%) supports MRI-based follow-up and neurological assessments in trials.

• Coronary spasm and stenosis may occur with PFA applied near coronary vasculature, warranting caution in such regions.

• Future catheter designs should allow selective energy delivery to balance safety and efficacy in different anatomical zones.

EARLY TAVR Trial Confirms Benefit of Early Aortic Valve Intervention Across All Age Groups

Introduction

In a paradigm-shifting update for cardiologists managing severe aortic stenosis (AS), new data from the EARLY TAVR trial reveal that patients, regardless of age—derive significant benefit from early transcatheter aortic valve implantation (TAVI) even before symptoms emerge. These findings, presented at SCAI 2025, come on the heels of FDA approval for the Sapien 3 valve for asymptomatic severe AS, signaling a strong shift toward proactive intervention over watchful waiting.

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The Case for Early TAVI: A Progressive, Unpredictable Disease

Severe AS has long been recognized as a progressive and potentially deadly disease, even when asymptomatic. The EARLY TAVR trial confirms that early intervention with TAVI reduces the composite risk of death, stroke, or unplanned cardiovascular hospitalization, compared with clinical surveillance.

“You want to do the procedure electively when the patient is stable,” said investigators, emphasizing the importance of planning ahead and initiating shared decision-making.

Source: NEJM
 

Key Findings Across Age Groups

The trial stratified patients into four age groups: 65–69, 70–74, 75–79, and 80+. The primary outcome consistently favored TAVI across all age brackets:

• 65–69 years:
  Dramatic reduction in death, stroke, or HF hospitalization:
  TAVI 4.7% vs Surveillance 25.6% (P = 0.016)
  Stroke rates: 0% with TAVI vs 13% with surveillance

• 80+ years:
  Stroke: 4.2% with TAVI vs 16.5% with surveillance
  HF hospitalization: 8.7% vs 19.4% (P = 0.008)

• 70–74 years:
  HF hospitalization reduced: 0.8% with TAVI vs 9.2% (P = 0.005)

Despite differences in comorbidity burden across age groups, the benefit of early TAVI persisted. Conversion to AVR in the surveillance group occurred at similar rates regardless of age, and importantly, 25% of strokes occurred during the wait period before delayed AVR.

Practical Implications for Clinicians

• Get dental clearance early to avoid procedural delays.

• Start shared decision-making discussions during the asymptomatic stage.

• Recognize early symptoms may be underestimated, as up to 20% of “asymptomatic” patients had guideline-based indications for AVR after workup.

• Consider subclinical cardiac damage and valve calcification progression when delaying treatment.

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Edwards Lifesciences' FDA-approved Sapien 3 TAVI platform for asymptomatic severe AS
Image source

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Key Takeaways for Busy Clinicians

• Early TAVI outperforms surveillance in asymptomatic severe AS, regardless of age.

• Major endpoints—death, stroke, HF hospitalization—are reduced with TAVI.

• Benefits are particularly striking in younger (65–69) and older (80+) patients.

• Up to 25% of strokes occurred during the watchful waiting period.

• Clinicians should begin planning early with thorough workups and shared decision-making.

TAVI in Women: Patient-Prosthesis Mismatch Doesn’t Impact Long-Term Survival

Introduction
As transcatheter aortic valve implantation (TAVI) expands into younger and lower-risk populations, patient-prosthesis mismatch (PPM) remains a hot topic—particularly in women with smaller annuli. A new multicenter analysis presented at the SCAI 2025 Scientific Sessions offers a reassuring message: while women are more likely than men to develop PPM after TAVI, this does not translate into worse long-term survival.

This finding challenges traditional assumptions about PPM and underscores the need for nuanced, patient-centered valve selection—especially for female patients.

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Understanding PPM in the Context of TAVI
PPM occurs when the effective orifice area of the prosthetic valve is too small relative to the patient’s body size, potentially leading to higher gradients and adverse outcomes. While this is a known concern in surgical aortic valve replacement (SAVR), its implications in the TAVI era are more complex.

Key insights include:

• Women had higher rates of predicted and echocardiographically measured severe PPM than men:

  • Predicted severe PPM: 1.7% (women) vs. 0.1% (men)

  • Measured severe PPM: 7.3% (women) vs. 5.4% (men)

• Despite this, 5-year survival was unaffected by PPM severity in women.

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Study Details
A total of 3,016 TAVI patients (44% women, mean age 80) treated across six hospitals within the Baylor Scott & White Healthcare System (2012–2021) were retrospectively analyzed:

• Balloon-expandable valves (Edwards Sapien series) were used in 74% of patients.

• Women were more likely to experience moderate or severe PPM, especially with balloon-expandable devices.

Despite theoretical concerns, measured or predicted PPM had no significant impact on 5-year survival—even among women with higher mismatch rates.

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The Valve Type Question: Self-Expanding vs Balloon-Expandable
Interestingly, moderate PPM was more frequent with balloon-expandable valves:

• Predicted moderate PPM: 31.3% (balloon-expandable) vs. 8.2% (self-expanding)

• Measured moderate PPM: 22.9% vs. 11%, respectively

Yet, a slight survival trend was noted:

• Women with self-expanding valves and moderate PPM showed a lower unadjusted 5-year survival vs. those without PPM (P = 0.0230)

• After risk adjustment, this trend disappeared—likely due to the small sample size (only 26% had self-expanding valves).

The SMART trial and other studies suggest self-expanding valves may offer better hemodynamics in small annuli, making them a valuable option for women.

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Sex-Based Differences: Real-World vs Clinical Trials
A notable finding: men with PPM fared worse than women at 5 years, contradicting older assumptions and highlighting the role of sex-specific physiology and valve-patient interactions.

This emphasizes the need for real-world data to complement clinical trials, especially when making lifetime management decisions in aortic stenosis.

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Clinical Implications & Future Research Directions
Although PPM remains undesirable, this study suggests it may be less clinically impactful after TAVI—especially for women—than previously thought.

Key considerations:

• Individualized valve selection remains crucial.

• PPM should still be avoided when possible, but its presence may not mandate aggressive interventions in women.

• Ongoing trials comparing SAVR with root enlargement vs TAVI in women may further clarify optimal strategies.

As more low-risk and younger patients undergo TAVI, the long-term impact of PPM—and valve choice—will become increasingly relevant.

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Key Takeaways for Clinicians

• Women undergoing TAVI have higher rates of PPM, especially with balloon-expandable valves.

• Despite this, 5-year survival is unaffected, suggesting PPM after TAVI may not carry the same mortality risk as with SAVR.

• Self-expanding valves may reduce PPM incidence in women with small annuli but didn’t confer a clear long-term survival benefit in this study.

• Men may be more adversely affected by PPM than women, highlighting sex-based differences in outcomes.

• Real-world evidence continues to refine valve selection and lifetime planning in aortic stenosis.

Unequal Access to GLP-1 Medications: The Stark Reality for Obesity Care in the U.S.

Introduction:

Despite their game-changing role in obesity and cardiometabolic disease management, GLP-1 receptor agonists remain out of reach for the vast majority of eligible Americans. A recent study analyzing data from over 277 million electronic health records reveals that fewer than 3% of qualifying patients with obesity received these therapies. Even more concerning are the stark disparities based on sex, race, socioeconomic status, and geography. The problem, however, appears rooted not in clinical inertia but in systemic access barriers.

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The Study: A National Lens on Prescribing Trends

Published in JAMA in May 2025, the research by Chungsoo Kim, PharmD, PhD, and colleagues at Yale School of Medicine, analyzed over 39 million U.S. adults with obesity but no type 2 diabetes using the Epic Cosmos Dataset, one of the largest collections of EHR data in the nation.

• Eligibility Criteria: Adults with BMI ≥30 kg/m² or BMI ≥27 kg/m² with one obesity-related comorbidity.

• Study Window: July 2020 to October 2024.

• GLP-1 Agents Tracked: Semaglutide (Wegovy) and Tirzepatide (Zepbound).

Key Findings:

• Only 2.3% (887,110) of eligible patients received a GLP-1 prescription.

• Those prescribed were generally younger (mean 47.3 years) and had a higher BMI (mean 39.0 kg/m²) than those not treated.

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Disparities in Access: Who Is Being Left Behind?

The study uncovered consistent and troubling disparities in prescribing patterns:

1. Gender Disparities

• Women were 2.5 times more likely to be prescribed a GLP-1 agonist than men (3.0% vs 1.2%).

2. Racial and Ethnic Inequities

• Non-Hispanic White: 2.4%

• Non-Hispanic Black: 2.3%

• Hispanic: 1.8%

• Non-Hispanic Asian: 1.7%
  The lower rates among racial and ethnic minorities suggest systemic barriers beyond provider bias, including insurance coverage, affordability, and awareness.

3. Socioeconomic and Geographic Gaps

• Patients in rural regions: 1.5%

• Patients in urban regions: 2.4%

• Those in highly vulnerable socioeconomic areas: 1.9%

• Those in less vulnerable areas: 2.6%

The growth in prescription rates over time was concentrated in metropolitan, affluent areas, with minimal gains in rural or socially disadvantaged communities.

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Not a Physician Problem—It’s a System Problem

Interestingly, clinician access was not the limiting factor. Patients who eventually received a GLP-1 prescription had, on average, five clinical encounters in the preceding year, suggesting that provider interaction alone does not account for the underutilization.

Instead, cost and insurance coverage emerged as key drivers of disparity. The high out-of-pocket price of GLP-1 drugs—often exceeding $1,000 per month—and inconsistent insurance approvals create formidable barriers, especially for marginalized groups.

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Beyond Obesity: Expanding Clinical Promise of GLP-1s

GLP-1 receptor agonists have demonstrated benefit not only in weight loss and glycemic control but also in cardiovascular outcomes, heart failure, atrial fibrillation, and even obstructive sleep apnea. As evidence grows, equitable access becomes not just a health equity issue but a cardiovascular prevention imperative.

Learn more about GLP-1 clinical applications in obesity and cardiometabolic health from the American Diabetes Association and the American Heart Association.

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Conclusion: Call to Action

The glaring gap in GLP-1 utilization reflects deep-rooted systemic inequities, not clinical oversight. As policy evolves and new data emerge, stakeholders—health systems, payers, policymakers, and pharma—must prioritize strategies to expand affordability, coverage, and geographic reach.

Ensuring fair access to life-changing therapies like GLP-1s is not just a matter of good medicine—it’s a matter of health justice.

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Key Takeaways for Clinicians

• Fewer than 3% of eligible U.S. patients with obesity received GLP-1 drugs from 2020 to 2024.

• Significant disparities were seen by sex, race/ethnicity, and geography, independent of provider access.

• Men, minority groups, rural dwellers, and socioeconomically vulnerable populations had markedly lower access.

• Cost and insurance coverage, not physician bias, are the primary barriers.

• As GLP-1 agents show benefit across multiple cardiometabolic diseases, ensuring equitable access is vital to maximizing their public health impact.