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Lowering Elderly LDL-C | Merck Halts HYPERION
February 6, 2025
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Together with
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“The elderly had twice the absolute benefit from long-term PCSK9 inhibition compared with younger patients. Hopefully the guidelines will change to reflect this and recommend fully intensive lipid lowering in older patients with ASCVD.”
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Christopher Cannon, MD on evolocumab’s lipid lowering potential.
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The cardiac remote patient monitoring arena has undergone a massive evolution over the last 15 years, and the emergence of new technologies suggest that an even greater shift is coming up. Tune in to the latest Cardiac Wire Show with cardiac RPM leader Ken Nelson for a deep dive into the next frontier of cardiac digital health.
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Cardiology Pharmaceuticals
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Sooner certainly seems to be better than later when it comes to treating LDL-C levels with the PCSK9 inhibitor evolocumab (Amgen’s Repatha), and according to a recent JACC study, that’s especially true for older patients.
- People aged ≥75 years make up ~65% of all deaths linked to cardiovascular disease, with age being one of the primary risk factors for ASCVD.
- However, the potential for low effectiveness and unfavorable safety profiles has led to fewer guidelines for treating older patients using non-statin lipid lowering drugs.
Putting age before beauty, researchers conducted a prespecified analysis of the FOURIER-OLE study and found that among roughly 6.6k patients, evolocumab reduced the study’s composite primary endpoint of CV death and complications by twice as much in older patients (≥75) than in younger ones (<75) compared to placebo.
- Earlier evolocumab initiation reduced the rate of CV death, MI, stroke, hospitalization, or revascularization by 21% in older patients and 14% in younger patients.
- Evolocumab achieved over 2x greater risk reductions in older patients (5.4% vs. 2.3%), leading to a far lower number needed to treat to avoid one event (19 vs. 44).
- Incidence rates of safety events appeared similar across both age groups, suggesting that the PCSK9i is safe for older patients.
Despite evolocumab’s effectiveness, current AHA/ACC guidelines don’t list non-statin lipid lowering agents as a potential prevention for ASCVD, leading to less prescriptions and availability for these therapies.
- At least insurance isn’t an issue. With evolocumab now covered under Medicare, the drug’s once $600 list price isn’t what most patients are paying for it.
The Takeaway
When you consider that older patients see nearly twice the benefit with PCSK9 inhibitors, guidelines that shy away from non-statin LDL-C therapy might not make sense. After all, it’s not just about increasing patient lifespans when healthspan is on the table too.
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Cardiology AI: From Research to Clinical Practice
Explore how AI algorithms are reshaping cardiology with insights from Tempus’ recent webinar, featuring Dr. David Ouyang of UCLA and Cedars-Sinai, alongside Tempus’ Dr. John Pfeifer and Dr. Brandon Fornwalt. This expert panel dives into how AI can bridge diagnostic gaps, enhance patient outcomes, and streamline workflows for conditions like AFib and pulmonary hypertension. Read the full recap to glimpse the future of AI-driven cardiology.
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Plaque Analysis Now Covered by Medicare
HeartFlow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.
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Innovating AFib Care
The first manifestation of AFib is often stroke, but many hospitals aren’t set up to coordinate these patients’ post-stroke care. See how UCSD is leveraging Viz.ai’s Viz Connect solution to simplify neuro and EP collaboration in this HRX 2024 interview.
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- Merck Stops HYPERION: Merck stopped its Phase 3 HYPERION study for its WINREVAIR (sotatercept-csrk) PAH drug due to positive interim analysis of the ZENITH trial and overall data from the WINREVAIR program. The program’s steering committee unanimously decided that HYPERION was no longer needed for proving WINREVAIR’s efficacy and made the drug available to all participants. While WINREVAIR is already FDA approved for the sickest of PAH patients, the strong results could lead to FDA approval for all PAH patients, including those recently diagnosed.
- Boosting Lipid Screening: Bulk ordering prescriptions and text messaging could help boost the effectiveness of lipid screening outreach, which would be a big win for both providers and patients. A recent clinical trial found that among 1,000 randomized patients, those receiving bulk orders and outreach messages increased their screening appointments significantly (+9.8%) compared to usual care after three months. However, there was no difference after six months and more than 80% of patients did not follow through with lipid screening.
- Viz.ai Improves Post-Stroke Care: Viz.ai announced results from a clinical study highlighting the impact of its Viz Connect care pathway on post-stroke patient care. During the study, Viz Connect led to 8.4x more patients receiving guideline-driven cardiac monitoring and decreased the median time to device placement by 97% for Insertable Cardiac Monitors (from 32 days to 1 day) and 59% for External Event Monitors (from 22 days to 9 days).
- Philips + Myocardial Solutions: Philips partnered with Myocardial Solutions to integrate the two companies’ technologies for detecting early signs of cardiotoxicity in patients undergoing cancer treatments. The duo will combine Philips’ Fast-SENC rapid MRI acquisition sequence with Myocardial Solutions’ MyoStrain analysis tool to enable rapid heart strain and dysfunction reporting in just 10 minutes.
- Merge Cardiology is Best in KLAS: Merge Cardio and Merge Hemo continued their KLAS dominance, ranking Best in KLAS 2025 for Cardiology and Hemodynamics for the 10th and 13th time, respectively. Merge by Merative’s Merge Cardio platform further expanded its KLAS score lead this year, scoring 83.8 (up from 82.8 last year) thanks to software improvements and quality of life additions. Meanwhile, Merge Hemo leveled off a bit at 89.3 (down slightly from 91.5 in 2024).
- Contaminated BP Drugs: Provepharm issued a recall for one lot of its phenylephrine hydrochloride injections after “visible black particulate matter” was found in a customer’s sealed vial. The FDA warns that the injections could cause local swelling or irritation or even vascular complications, and advised customers to check their injection vials for lot number 24020027. Customers with these vials should return them to Sedgwick, which is helping Provepharm with the recall.
- BrightHeart’s Ultrasound AI: BrightHeart presented two studies at the SMFM 2025 Pregnancy Meeting highlighting its AI technology for improving fetal heart ultrasound. The first study showed how BrightHeart’s FDA-cleared AI software significantly improved congenital heart defect detection rates, with a 15.3% increase in sensitivity, while cutting reading time by 18%. The second study demonstrated that the AI provided accurate CHD conclusions for 98.8% of exams, with 98.7% sensitivity and 97.7% specificity.
- Return of the Ross: New data from STS 2025 suggests the Ross procedure could be making a comeback. Used for treating young people with severe aortic valve disease, the Ross procedure involves a complex technique of replacing a patient’s diseased aortic valve with their healthy pulmonary valve, and although it takes twice as long as mechanical AVR, survival rates range from 95.8% at five years to 90.3% at 20 years. Thanks to its strong survivability, the procedure saw a sevenfold increase in use from 2013 to 2023 (66 to 531).
- Sedentary Behavior Risks: Sitting around too much may directly increase your future CVD risk. Across UK Biobank analysis of nearly 90k individuals, those who were sedentary for more than 10.9 hours per day (top 25%) faced higher risks of HF (+45%), CV mortality (+62%), incident AF (+11%), and MI (+15%). These risks were present even in individuals who met guidelines for moderate to vigorous physical activity, suggesting that reducing sedentary time could be more effective than short intervals of intense exercise.
- A New DMD Heart Drug: Cumberland Pharmaceuticals announced positive top-line results from its Phase 2 FIGHT DMD trial evaluating its oral Duchenne muscular dystrophy therapy, ifetroban. Across 41 DMD patients who received either low-dose ifetroban (150 mg), high-dose ifetroban (300 mg), or placebo, the high dose treatment cohort achieved a 3.3% improvement in LVEF. These results could be a breakthrough for DMD patients, since there are currently no drugs from treating DMD-related heart disease.
- Biome’s HF Module: Adding another tool to its Foundations Reporting Platform, Biome Analytics launched the Heart Failure Performance Module for improving heart failure care, patient outcomes, and operational efficiency using advanced analytics and AI-driven insights. The new module uses AI to identify patients at risk of worsening heart failure and readmissions, while offering performance metrics compared to leading cardiovascular institutions.
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How to Overcome Cardiovascular Data Challenges
Managing cardiovascular data is a complex and confusing process. Head over to Optum’s article on best practices like aggregating multisource data to prevail over common issues related to cardiology data and analytics.
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Automating and Simplifying CMR Imaging
Watch Vista.ai’s demo on how their intelligent software automates and simplifies image acquisition so all technologists can perform a CMR scan with quality, consistency, and efficiency, increasing throughput and improving patient access.
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- Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow.
- Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)
- Your Cardiology Data is Valuable. Put it To Work. See how one major Midwest health system’s decision to implement Merge Cardio transformed physician and staff workflows, improved data entry speed and accuracy, and increased cost savings.
- The Efficiency of the Kinetic Rhythms ECG Algorithm: See how you can interpret up to twenty-nine distinct rhythms by embedding the Kinetic Rhythms ECG Algorithm on your device or software suite. Ensure precise ECG interpretations regardless of whether they’re taken at the bedside or in an ambulatory setting.
- AI-Echo for Cardiac Amyloidosis: Despite advancements in cardiac imaging, cardiac amyloidosis remains significantly underrecognized and underdiagnosed. Discover how Us2.ai’s deep learning diagnostic algorithm uses echocardiography and apical 4-chamber DICOM images to detect CA.
- Experience the future of learning: Medtronic Academy 2.0 is here! Unlock your ultimate destination for structural heart medical education with the newly redesigned Medtronic Academy 2.0. Gain access to expert-led courses, webinars, and a wealth of resources to stay ahead in cardiovascular care. Visit now!
- New Horizons in Structural Heart: TAVR and TMVR rates are rising rapidly, placing more pressure on interventional planning. Tune into this Circle CVI and Radcliffe Cardiology breakout detailing how to leverage modern CT workflows to produce efficient and accurate pre-procedural plans.
- PIA’s Post-Processing Solution: Advanced cardiac imaging often calls for a time-consuming post-processing step, requiring costly software, hardware, and training. See how PIA provides this post-processing at lower cost, improved consistency, and greater efficiency.
- Predicting Coronary Events With Plaque Analysis: How can measuring non-calcified plaque burden change how we detect heart disease? Tune-in to Cleerly’s on-demand webinar featuring Sarah Bär, MD, PhD to discover how Cleerly’s AI-powered coronary CTA plaque analysis is reshaping CAD risk prediction, beyond standard tests.
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