UK cardiologist and possible beetroot juice proponent, Andrew Sharp, MBChB MD FRCP.

Pharmaceuticals

Abelacimab Significantly Reduces Bleeding

Anthos Therapeutics celebrated its Phase II results showing that its novel Factor XI inhibitor abelacimab significantly reduced bleeding among AFib patients compared to the immensely popular blood thinner rivaroxaban (Xarelto).

• Abelacimab is an investigational monoclonal antibody that locks the Factor XI blood clotting protein in its inactive state, potentially allowing thrombosis treatment without affecting hemostasis.
• The drug was originally developed by Novartis, before being acquired by Blackstone Life Sciences (Anthos’ parent company) for $250M in 2019.
• We haven’t yet confirmed how abelacimab measures up to rivaroxaban for reducing stroke risks, but if it proves non-inferior for stroke prevention it could significantly expand anticoagulant treatment options for older and more frail patients.

The AZALEA-TIMI 71 trial included 1,287 global AFib patients with moderate-to-high stroke risks, following them for a median of 21 months before the trial was halted due to “an overwhelming reduction” in bleeding events.

• The study had abelacimab patients receive either 90 mg or 150 mg subcutaneously each month, or 20mg of rivaroxaban orally every day. 

Actual data on the abelacimab arm’s reduction in bleeding events won’t come out for several months. However, study authors give plenty of reasons to have high expectations, calling the reductions in major or clinically relevant bleeding events “overwhelming,” “unprecedented,” and “highly significant” versus standard-of-care treatment with rivaroxaban.  

• Anthos also initiated an extension study evaluating patients who were originally in the rivaroxaban arm and switched to abelacimab after the original trial was halted.

Although abelacimab’s immediate next steps are to release full AZALEA-TIMI 71 results and complete its extension study, most attention will be on an ongoing Phase III study confirming its effectiveness with stroke reduction.

The Takeaway

It’s been a while since we’ve seen the medical community get this excited about trial results that didn’t include actual data, highlighting how much clinical demand exists for anticoagulants that don’t pose significant bleeding risks. Abelacimab still has a lot to prove, but if it matches rivaroxaban on stroke prevention it could be well positioned to meet that demand.

Cardiovascular Structured Reporting Adoption Benefits

Check out this Change Healthcare report detailing the benefits of cardiovascular structured reporting, and how to drive structured reporting adoption in your own organization.

The First Step to Coronary Artery Disease Diagnosis

HeartFlow’s new RoadMap Analysis solution allows CT readers to accurately, efficiently, and consistently identify stenoses in the coronary arteries. See how RoadMap Analysis’ visual and quantitative insights into the narrowing of all major coronary arteries helps readers evaluate coronary CT angiograms before determining the need for an FFRCT.

The Wire

• WHO’s Silent Killer Report: The World Health Organization got the world talking about blood pressure this week, releasing a comprehensive new report detailing undetected hypertension’s massive clinical and economic impacts. Although this report has likely already reached most hypertension experts’ inboxes or social media feeds, high blood pressure’s impact across most CV conditions makes it a worthy read for anyone in cardiology.

• CardioOne’s Big Week: CardioOne made headlines with the announcement of $8M in funding, an expansion to three new practices (in NJ, PA, FL), and an alliance with MedAxiom. CardioOne exists to help cardiology practices thrive while staying independent, providing them a platform that combines technology, talent, and administrative support to reduce operational burdens and streamline their expansion into value-based care. The company got its start at Redesign Health last year, and already had practice partnerships in Texas and Maryland.

• Post-MI High-Risk Plaques: A JAMA study revealed that heart attack patients who have FFR-negative high-risk plaques (identified via OCT) have far greater future MACE risks. Among 420 MI patients, the 143 patients with high-risk plaques had a far higher MACE rate over two years (15% vs. 8%). Researchers said the results show that MI patients with high-risk plaques require treatment to prevent unplanned revascularizations, noting that nearly two thirds of their events were for revascularizations.

• SpectraWAVE Adds Saline Imaging and AI: SpectraWAVE expanded the capabilities of its HyperVue Intravascular Imaging System, following its FDA clearance for contrast-free saline imaging, hands-free angiographic co-registration, and new AI algorithms to identify calcium and external elastic lamina. The HyperVue system first landed its FDA clearance in March, and combines SpectraWAVE’s DeepOCT and NIRS spectroscopy technology within a no-flush catheter, supporting both image acquisition and AI-based image review to help physicians optimize coronary stent placement in the cath lab.

• Specialists Crowding Out PCPs: KFF put out a nice viewpoint on how US healthcare’s specialty-driven model has contributed to the disappearance of primary care physicians. In 1980, 62% of doctor’s visits for patients aged 65+ were for primary care (38% were for specialists), but that ratio had exactly flipped by 2013. Part of the blame – and probably part of the solution – lies in a reimbursement structure that incentivizes surgeries/procedures over diagnostics/preventative care.

• No Nearby Cardiologists: A research letter in Circulation revealed significant differences in how close Americans live to the US’ 47k estimated cardiologists. Overall, 85.2% of people live within 20 km of a cardiologist, but distances vary significantly between urban and rural areas (94.1% vs. 49.7%). Far fewer Americans live within 20 km of cardiology specialists (75.4% interventional, 65.9% electrophysiology, and 39.1% heart failure), and Americans with HF faces often have to travel over 100 km to see their specialist. 

• Wellysis ECG Patch Comes to the US: Samsung spinoff Wellysis announced the FDA clearance of its S-Patch Ex wearable device, expanding to its 15th country globally after gaining its CE Mark in 2021. Weighing-in at just 9 grams, the single-lead S-Patch Ex records patients’ ECG and heart rates in home and clinical settings for up to 72 hours. The patch syncs with a range of devices that patients use to input symptoms, then transfers the data to a portal used by monitoring clinicians.

• SmartCardia’s 7-Lead ECG Patch: Two days later SmartCardia announced the FDA clearance of its 7L ECG patch, which as its name suggests features 7 leads for more accurate arrhythmia detection, and can be used continuously for up to 14 days. SmartCardia’s 7L patch and associated cloud platform is intended to cover “the entire spectrum of cardiac monitoring including screening, post-operative follow-up, and remote patient monitoring.” The system already has a CE Mark and is available in Europe and Asia.

• Pediatric Drug Burdens After Heart Surgery: In a new JACC study using Medicaid claims data, ~40% of 5,459 children who previously underwent heart surgery were on at least one chronic medication versus 10% of the 4.5M children who did not. As you might expect, drug expenses were about eight times higher for enrollees who previously underwent cardiac surgeries ($2,654 vs. $328 per person-year), with the drug palivizumab (Synagis) accounting for 42% of the costs for the cardiac enrollees (6% for noncardiac).

• Field’s PFA Funding: Field Medical completed a $14M seed round to support the development of its pulsed field catheter ablation system. The company’s core products – the FieldForce Catheter and the FieldForce Generator – use proprietary FieldBending technology which is reportedly a “major step” beyond first-generation PFA technologies. Field Medical launches a rare level of PFA credibility given that it was founded by the “father of cardiac pulse field ablation,” Farapulse founder Dr. Steven Mickelsen.

• Propped Up at Adena Health: The controversies surrounding the Ohio-based Adena Health System’s cardiology department hit a bizarre peak this week, amid allegations that they “propped up” an already deceased patient and urged her family to remove her from life support. The 65-year-old woman reportedly died after an artery was cut during a routine heart catheterization procedure. Although medical records stated a 1:00 PM time of death, it was listed as 3:05 PM on her death certificate – the same time that her family “removed” her from life support.

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.

AI Echo Copilot – The Future of Echocardiography

New technology from Us2ai called Us2.connect allows you to add AI automation to any echo device. Any echo machine can now have 100% automated reporting with disease detection and editable measurements – all generated in realtime as you scan.

The Resource Wire

• Cardiologists are increasingly relying on cardiac CT angiograms as a heart disease diagnostic tool. See what’s driving this trend in this Cleerly report detailing the key attributes of CCTA exams, evidence of its effectiveness, and CCTA’s medical guideline support.

• The growth of cardiac CT and CMRI volumes and continued shortages in the imaging technologist workforce can mean big challenges for imaging organizations. Join this Cardiac Wire Show starring Precision Image Analysis’ Jim Canfield and Cleveland Clinic’s Scott D. Flamm, MD, MBA to see how outsourcing cardiac image post-processing can solve this problem, while improving efficiency, accuracy, and standardization.

• Gain in-depth knowledge of fluoroscopic anatomy and cutting-edge imaging techniques with renowned expert, Dr. Nicolo Piazza. This five-session master class is happening now through November. Register now!