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Abelacimab’s Safety, CABG + Ablation, and UK TAVR Troubles
June 16, 2025
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Together with
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“Heard at the podium of London Arrhythmia Summit: ‘if you have a composite primary endpoint, it means you have a bad primary endpoint’…”
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John Mandrola, MD
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Cardiac CT usually improves through hardware advances and enabling the speed needed for high-quality images, but hardware is rapidly reaching its physical limitations and represents a large financial investment. Read this Cardiac Wire exclusive from Philips Healthcare about how software and AI are driving the next leap in cardiac image quality and motion control – offering more affordable CT solutions and broader patient access.
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Cardiology Pharmaceuticals
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A new analysis of AZALEA-TIMI 71 suggests Anthos Therapeutics’ abelacimab is capable of reducing major bleeding in patients with AFib undergoing invasive procedures.
- Abelacimab is a factor XI inhibitor that helps lower the risk of bleeding in patients who need anticoagulation and usually lasts for over 28 days after a single dose.
- Currently, standard practice is to interrupt anticoagulation one to two days before most procedures for patients with AFib, but abelacimab could help avoid this.
The sub-analysis examined a total of 920 procedures across 441 patients taking either abelacimab or rivaroxaban, with approximately 1-in-3 patients undergoing an invasive procedure over a median follow-up of 2.1 years.
- Overall, periprocedural major or CRNM bleeding was low for both groups combined (<2% of all procedures).
- More specifically, major bleeding was almost half as likely to occur during procedures in the abelacimab group (1.2%) versus the rivaroxaban group (2.2%).
- The bleeding rate in the abelacimab group was even lower for procedures occurring within 30 days of an abelacimab dose (0.9%).
Researchers concluded that patients with AFib treated with abelacimab can undergo invasive procedures with low rates of bleeding and suggested that interrupting anticoagulation may not be necessary for all procedures where a patient is taking a factor XI inhibitor.
- However, as supportive as the data is on abelacimab, it still hasn’t received full regulatory approval.
- Where the bigger value lies is in the proof that abelacimab is safe, even if not discontinued before a procedure since it has such a long half-life.
The big ticket question is still whether or not abelacimab reduces the risk of stroke, noting that AZALEA-TIMI 71 didn’t show stroke improvements (and wasn’t designed for stroke outcomes), but the ongoing LILAC-TIMI 76 trial for high-risk patients with AFib might give deeper insights.
The Takeaway
Factor XI inhibition with abelacimab lasts a long time, so discontinuing it before a procedure isn’t really an option. Thankfully the results of this sub-analysis help underscore just how safe it is even if the patient is still on it during a complex or invasive procedure.
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Heartbeats and EP Insights – How GE HealthCare Streamlines Cardiac Care
Are you stuck behind EP reporting backlogs? Take a break and join GE HealthCare for a 15-minute conversation with Dr. Nicholas Skipitaris of Northwell Health on how to simplify reporting, reduce delays and standardize workflows to scale best practices.
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Revolutionize Your Cardiac CT Workflow — See It LIVE at SCCT 2025!
Be among the first to experience next-gen CV imaging at Booth #315 during SCCT 2025. Sign up now to find out how Circle CVI’s software enables lightning-fast LAAC, TAVR, and TMVR workflows while providing more accurate heart function insights, and clinician-controlled plaque quantification.
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Relieving The Burden of Post-Processing
With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.
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- Is AI the CCTA Answer? Coronary CTA has become the preferred non-invasive exam for detecting and ruling out coronary artery disease, but costs and backlogs threaten access. This Cardiac Wire exclusive breaks down how Philips Healthcare pairs AI with its CT 5300 system to provide a detailed assessment of coronary anatomy and visualizes atherosclerotic plaque, helping identify lesions that may restrict blood flow to the myocardium while lowering scan costs and increasing efficiency.
- Ablation During CABG: A recent ATS study suggests surgical ablation during isolated CABG in patients with preexisting AFib could help improve survival outcomes. Researchers examined data from 87k Medicare beneficiaries and found that patients undergoing surgical ablation during their CABG lived a median of 4.40 months longer compared to those without (risk-adjusted). That survival advantage was even greater in patients who were in the care of surgeons who frequently (>40% of the time) performed combined surgical ablation with CABG (4.96 months advantage).
- PREVENT + Lp(a): Adding lipoprotein(a) levels to the AHA’s PREVENT equations could help personalize and improve ASCVD risk prediction. A study in JAMA Cardiology analyzed 314k patients and found that PREVENT correctly predicted 10-year ASCVD event rates regardless of Lp(a) level, although participants with elevated Lp(a) had more ASCVD events than those without (HR: 1.30). Researchers concluded that adding elevated Lp(a) values to PREVENT modestly improved ASCVD risk prediction with the greatest improvement in borderline-risk prediction.
- FastWave’s Sola Succeeds: FastWave Medical announced the successful completion of its first-in-human procedures using its Sola coronary laser intravascular lithotripsy system. Sola is a rupture-resistant balloon catheter that breaks up coronary artery calcification using laser energy to deliver 360-degree pressure with each pulse. FastWave believes this design improves deliverability, energy output, and usability versus existing IVL devices. The company plans to use data from this study to help guide its regulatory submissions as well as the design of its U.S. pivotal trial.
- TAVR Trouble at Castle Hill: British Police are investigating the deaths of TAVR patients at the Castle Hill NHS hospital due to its 3X higher TAVR mortality rate compared to the rest of the UK. Documents examined by the BBC suggest patients suffered avoidable harm and that in some cases their death certificates failed to disclose that the TAVR procedure contributed to their deaths. So far, 11 patient cases have been brought under review by both the Royal College of Physicians and a consulting firm.
- PE Acquisitions Don’t Lead to Better Care: New research shows PE hospital acquisitions don’t improve HF care and outcomes. Researchers compared 41 PE-acquired hospitals and 192 matched control hospitals and found that acquired hospitals showed no change in 30-day HF mortality rates or 30-day revisit rates, despite patients having lower clinical HF risk at PE hospitals. Black patients were significantly more likely to be transferred to another site after PE acquisition (+7.1%) and cardiac catheterization rates increased (+0.7%) for all patients.
- Merck’s Growing CORALreef: Merck announced positive topline results from the first two of its CORALreef Phase 3 clinical trials evaluating its oral PCSK9i, enlicitide decanoate, for treating hyperlipidemia in patients already on lipid-lowering therapies. The CORALreef HeFH trial showed that enlicitide led to meaningful reductions in LDL-C versus placebo in adults on statins for HeFH. The CORALreef AddOn trial also showed meaningful reductions in LDL-C for enlicitide compared to HeFH patients on ezetimibe and bempedoic acid.
- Not All Weight Losers Are Equal: A new EHJ study suggests individual weight loss could vary based on genetic response to long-term lifestyle interventions for cardiometabolic risk. The study pooled data from three long-term weight loss-intervention trials and found that patient weight loss varied based on genetic and lifestyle factors. Ultimately, only one-third of individuals achieved long-term WL and site-specific DNA methylation helped predict an individual’s likelihood of successful WL.
- The Cost of Major Bleeding: A third party review of Cadrenal Therapeutics’ tecafarin found that LVAD patients face high bleeding risk due to oral anticoagulation, which adds significant treatment costs for hospitals. Researchers at Guidehouse uncovered that major bleeds remain a primary cost driver, with average hospitalization costs of $54k for intracranial hemorrhage, $26k for gastrointestinal bleeds, and $36k for other major bleeds. Guidehouse’s analysis also identified Cadrenal’s tecarfarin as a potential alternative to warfarin to address the bleed issues for this patient population.
- Jenscare’s Early Results: Jenscare Scientific released positive 30-day follow-up results from its TRINITY Trial that suggest the LuX-Valve Plus is safe and effective for treating severe TR. The study enrolled 161 patients from 20 global centers and found that 95.7% of patients had below moderate TR following treatment. When it came to safety, the study had a 1.8% all-cause mortality rate and unplanned mitral valve intervention rate of 5.3%.
- A New Cuffless BP Monitor: Korean digital health startup, Sky Labs, unveiled the world’s first ring-type cuffless blood pressure monitor as ESH 2025. Sky Labs’ BP monitor is a ring-type device that enables 24-hour monitoring without needing to stop any daily activities, while providing continuous nocturnal readings which could enable a new approach to hypertension management. The company plans to launch a consumer-focused version of the ring-type monitor called CART-BP in September though most patients and providers are generally wary of cuffless BP accuracy.
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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)
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Vista AI Reduces Patient Backlog
Cardiac MRI is infamous for its complexity and backlogs, but it doesn’t need to be that way. See how Vista Cardiac delivered a 50% reduction in scan time variability, enabling shorter scheduling blocks and eliminating a one-month backlog.
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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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- Cloud-Based Enterprise Imaging Empowerment: Do your cardiology imaging workflows follow cloud best practices? Read Optum and Frost & Sullivan’s enterprise imaging whitepaper to help you ensure your team is optimally housing, accessing, analyzing, and leveraging imaging data as the industry shifts to value-based care.
- Monebo’s Approach to Cardiac Health Monitoring: The heart works day and night, so your cardiac monitoring software should too. Learn about how Monebo’s latest innovation superimposes long-term monitoring results onto a 24-hour circadian cycle scale, creating a comprehensive map of circadian variations.
- How to Improve Cardiology Workflows and Get More Patient Time: Complex processes and reporting requirements can mean cardiologists spend more time with clinical systems than they do with their patients. See how Merge Hemo and Merge Cardio work together to help you streamline and scale your clinical and data management workflows, so you can have more time in front of your patients.
- Us2.ai and Fujifilm Automate CVUS: Fujifilm Healthcare Americas and Us2.ai have partnered to equip the LISENDO 880 cardiovascular ultrasound system with an AI-driven clinical workflow solution. Read more about how Us2.ai fully automates the LISENDO 880’s echocardiogram analysis and reporting.
- Heartflow Plaque Analysis: Accurate CAD Assessment Now Covered Across the US: 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.
- 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
- Identify and Treat Cardiovascular Disease: Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.
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