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Obicetrapib Cuts LDL-C | First Total Artificial Heart
August 1, 2024
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Together with
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“It was amazing when it was first discovered over 100 years ago, and now we’re unlocking it with AI.”
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AccurKardia’s Moin Hussaini on how AI is expanding ECG far beyond arrhythmia detection.
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Are we just scratching the surface of what ECG can do, especially with the emergence of AI? Check out this Cardiac Wire Show interview with AccurKardia’s Moin Hussaini where we discuss how AI can expand ECG-based detection to brand new clinical areas, while streamlining today’s ECG-based arrhythmia workflows.
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Topline results are in from NewAmsterdam Pharma’s BROOKLYN study, showing that obicetrapib safely and effectively reduces LDL cholesterol in patients with heterozygous familial hypercholesterolemia (HeFH) who can’t be effectively treated by current cholesterol drugs.
- Obicetrapib is an once-daily oral medication that inhibits the CETP protein to reduce LDL-C levels and potentially decrease cardiovascular risks.
- The drug achieved solid LDL-C reductions in previous studies, and is now the focus of four pivotal trials, starting with the BROOKLYN study.
The Phase 3 BROOKLYN trial evaluated 10 mg obicetrapib in 354 randomized HeFH patients whose LDL-C wasn’t adequately controlled despite taking maximally tolerated lipid-lowering therapy.
The results appeared quite positive for obicetrapib, which…
- Achieved a 36.3% LDL-C reduction after 84 days (the primary endpoint), and maintained a 41.5% reduction through one year.
- Reduced 51% of patients’ LDL-C levels below 70 mg/dl.
- Drove significant reductions in HDL-C, non-HDL-C, Lp(a), and Apo(B).
- Was well-tolerated, with safety results comparable to placebo, no increases in blood pressure, and lower treatment discontinuation rates (7.6% vs. 14.4%).
Despite these improvements, obicetrapib’s LDL-C reductions in the BROOKLYN study fell short of its previous Phase 2 trial that achieved a 51% average reduction when taken alone, driving NewAmsterdam’s stock price down 28%.
- However, the BROOKLYN patients were already on maximum lipid lowering meds (14% on PCSK9I, 54% on Ezetimibe + HI statin), potentially skewing the trial’s LDL-C reductions.
Either way, these results make obicetrapib’s three other pivotal Phase 3 studies even more high stakes. The BROADWAY, TANDEM, and PREVAIL trials will use obicetrapib alone or with other lipid-lowering drugs across a range of patients, while evaluating cholesterol reduction or cardiovascular outcomes.
The Takeaway
NewAmsterdam still has a long way to go to prove obicetrapib’s value in the crowded lipid-lowering arena, but the BROOKLYN trial is a solid step towards that goal.
It might not have met Wall Street’s LDL-C expectations, but these results seem like good news for the estimated 1.33 million Americans with HeFH, and NewAmsterdam’s wave of forthcoming studies should paint a much clearer picture of how obicetrapib can help an even wider range of patients.
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Streamlining Cath Lab Hemodynamic Workflows
Is your hemodynamic solution keeping your cath lab efficient? Merge Hemo is a cath lab hemodynamic monitoring solution, providing a Best in KLAS user experience, while enhancing clinical workflows, automating data collection, and streamlining inventory management.
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Catch up on 2024’s Cardiology Coffee Breaks
Join GE HealthCare on a journey to bridge the gaps to connected cardiovascular care with this season’s Cardiology Coffee Breaks. In the time it takes you to finish your coffee, these Coffee Breaks demonstrate how GE’s integrated solutions empower healthcare organizations to provide precision care, achieve operational efficiency, and enhance patient satisfaction.
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Forging the Future of Cardiovascular Care
Cardiology is changing, and for the better. Get a view into Lee Health Heart Institute’s medical director Richard Chazal, MD’s vision for a new era in cardiology, driven by imaging, AI and personalized medicine.
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- First Total Artificial Heart: The BiVACOR Total Artificial Heart was successfully implanted in a human for the first time, representing a key step towards the valveless artificial heart becoming an option for patients awaiting heart transplant. The Texas Heart Institute implanted the BiVACOR TAH in a patient with end-stage heart failure as part of an early feasibility study that will eventually include four other patients. The BiVACOR TAH is a novel titanium biventricular rotary blood pump that replaces both ventricles of a failing heart.
- MGB Equal Pay Lawsuit: A Mass General Brigham cardiologist filed an Equal Pay Act lawsuit against her longtime employer, noting that a male MGB cardiologist (who she helped train) earns nearly $100k more than her annually. Marie Denise Gerhard-Herman, MD earns $255k annually, well below her male colleague’s $350k reported salary. When Dr. Gerhard-Herman inquired about this pay discrepancy, hospital leadership explained that it was due to the male colleague’s added leadership responsibilities, although she contends that their leadership duties are similar.
- Afib Ablation’s Big Benefits: A systematic review of 22 randomized controlled trials added more evidence showing that Afib catheter ablation significantly reduced hospitalizations (-43%), Afib relapse (-52%), and all-cause mortality (-31%). Ablation also improved a range of secondary endpoints, including cardiovascular mortality, cardiovascular hospitalizations, heart failure hospitalizations, LVEF, and quality of life.
- Us2.ai Expands to Japan: Echo AI leader Us2.ai is expanding to Japan through a partnership with local healthcare AI platform company M3 AI and Juntendo University, including optimizing the solution for use by Japanese clinicians. Japan will be Us2.ai’s 26th country, and it has the potential to be one of its biggest markets, noting its aging population, sonographer shortages, and huge echo volumes (9.47M /yr; 1.3x the U.S.’s volume).
- How Dapagliflozin Helps HFpEF: A secondary analysis of the CAMEO-DAPA study (n=37) took a deeper dive into effects of the SGLT2i dapagliflozin (AstraZeneca’s Farxiga) on HFpEF patients during exercise. Compared to placebo, dapagliflozin improved pulmonary artery compliance (+0.57/mL/mm), decreased PA stiffness (-0.17 mm Hg/mL), and improved RV function by increasing the PA pulsatility index (+0.33). The changes are related to dapagliflozin’s pulmonary capillary wedge pressure reduction that was shown in the initial CAMEO-DAPA analysis.
- TRiCares’ TTVR Funding: TTVR startup TRiCares raised a $50M Series D round from an unnamed strategic investor to support the development of its Topaz transfemoral tricuspid heart valve replacement system. The Topaz TTVR has plenty of R&D ahead of it, including completing its U.S. early feasibility study, initiating its European and U.S. pivotal trials, and developing additional valve sizes and a next-generation delivery system.
- Echo AI Outcomes: There’s plenty of studies highlighting echo AI’s accuracy and efficiency, but a JASE study tied echo AI’s findings to patient outcomes for the first time. Mayo Clinic researchers applied Ultromics’ EchoGo solution to 1,284 patients with and without HFpEF and followed them for a median of 3.4 years. The AI achieved 89.8% sensitivity and 86.3% specificity, outperforming clinical scores, while patients who were flagged by AI had far higher risks of HF hospitalization (HR: 3.76) and cardiac mortality (HR: 5.55).
- Story Health x Zing Health: Story Health and Zing Health announced a partnership that will make Story’s cardiovascular virtual care platform and health coaches available to Zing’s historically-underserved Medicare Advantage members. Zing will identify eligible members with the greatest heart failure risks and connect them with Story’s cardiovascular care program, including coaches focused on “addressing social barriers to care.” This is the latest in a growing list of Story Health VBC partnerships, including Saint Luke’s, WVU, Intermountain, and ChristianaCare.
- New-gen Ballooning Matches Stenting for ISR: A comparison of the new generation sirolimus-coated balloons (SCB) versus thin-strut drug-eluting stents (DES) for treatment of patients with in-stent restenosis found no significant differences in revascularization (11.6% for DES vs. 11.8% for SCB) or MACE at 2 years (21.5% for DES vs. 17.6% for SCB). The treatments had similar efficacy and safety profiles, though SCB did show trends toward fewer myocardial infarctions (7.4% for DES vs. 5.0% for SCB).
- Apple’s ECG Access: The Apple Watch’s ECG feature gets plenty of attention for its Afib monitoring capabilities, but it could eventually be used for very non-cardiovascular use cases. Apple filed a patent that would leverage the ECG app to identify users’ unique heart rhythms and then allow access to a range of Apple devices, much like passwords or fingerprint scans are used today. The patent also covers using ECG for “mood” monitoring, potentially to customize music during a workout.
- New Intermediate CV Risk Score: A new AI-based lipidomics risk score (LRS) improved cardiovascular predictions among patients with intermediate CV risks, which could be notable given the Framingham Risk Score’s challenges with intermediate risk patients. The blood-based algorithm increased CV event prediction AUCs by 0.114 and 0.33 in patients from the AusDiab study and Busselton Health Study, with 0.36 and 0.33 net reclassification improvements. It also improved CAC score prediction AUCs by 0.02 in patients from the BioHEART study.
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Nothing Is More Expensive Than a Missed Opportunity
The emergence of AI CAC detection and new CVD treatments could transform preventative CVD care. Check out this Johns Hopkins editorial in JACC detailing how solutions like Bunkerhill Health’s Incidental CAC algorithm can create opportunities for more effective preventative CVD care, but only if providers seize that opportunity.
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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.
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- ECG Data You Can Trust: Noise and artifacts can make automated ECG analysis less reliable than what’s required for the exacting standards of cardiac safety trials. Monebo’s Kinetic Intervals ECG Algorithm provides precise interval measurements between any two points on the ECG waveform, allowing clinicians to utilize data they can trust.
- Us2.ai’s Contrast Echo Correlations: Check out what might be the first study evaluating the performance of AI-automated contrast echocardiography exams, which found that Us2.ai’s echo AI solution produced LV measurements with “good to excellent agreement” with human experts.
- The Post-Acute Stroke Game Changer: See how Viz Connect solution can optimize your post-acute stroke pathway. The Viz.ai solution allows the cardiology team to promptly receive Neurology referrals to evaluate patients with suspected Afib for cardiac monitoring and reduce their risk of secondary stroke.
- 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!
- Structured Reporting Cuts Late Charges: Structured reporting is often associated with efficiency improvements, but its ability to reduce errors and improve billing accuracy can deliver benefits across a cardiovascular service line. See how Baystate Medical Center’s transition to structured cardiology reporting with Optum helped them reduce unsigned charges by 79%.
- HeartFlow FFRCT Avoids Invasive Cath: Despite being conscious about his heart health, 60-year old Mike Gartman suddenly experienced classic symptoms of CAD. See how Mike’s HeartFlow FFRCT Analysis results allowed him to avoid the invasive procedure altogether and gain peace of mind about his disease.
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