An unnamed patient with high Lp(a) levels with another example of how LP(a) might be the best kept secret in heart disease.

——————–

First time reading Cardiac Wire? Sign up here.

Cardiology Pharmaceuticals

Novartis and Ionis Double Down on Lp(a)

Novartis and Ionis Pharmaceuticals doubled down on their Lp(a) alliance, launching a second collaboration focused on developing and commercializing a treatment for patients with lipoprotein(a)-driven cardiovascular disease. 

Novartis and Ionis are already deep into their initial Lp(a) alliance that led to the development of the antisense medicine, pelacarsen, which blocks the production of apolipoprotein(a), and is currently being evaluated in two Phase 3 trials and one Phase 2 trial.

• That initial collaboration has already earned Ionis $275M in upfront and milestone-based payments since 2017, and could be with up to $900M.

Encouraged by pelacarsen’s progress and the potential of Lp(a) treatments, Novartis will give Ionis another $60M upfront and unspecified future payments for the right to develop, manufacture, and commercialize their second antisense-based Lp(a) therapy.

• The companies believe that this follow-up antisense drug might offer even greater efficacy and dosing advantages, and have a better chance of becoming a leading Lp(a) treatment. 

Novartis and Ionis have good reason to continue their Lp(a) efforts, noting: 

• It’s estimated that up to 20% of people have high Lp(a) levels
• Elevated Lp(a) is strongly associated high higher CVD risks
• Lp(a) can’t be controlled through diet and exercise
• There’s still no effective and commercially-available Lp(a) treatments

That said, the companies could face plenty of competition by the time either of these drugs hits the market:

• Verve Therapeutics and Lilly similarly teamed on Verve’s Lp(a) gene editing therapy 
• Eli Lilly’s siRNA drug LY3819469 is in Phase 2 trials
• Amgen’s olpasiran posted solid Phase 2 results and is now in Phase 3 trials
• Silence Therapeutics’ RNAi-based Lp(a) drug is in Phase 2 trials

The Takeaway

Although we don’t currently have treatments for Lp(a), the efforts we’re seeing from Novartis, Ionis, and their competitors suggest that one might be on the way. And given Lp(a)’s potentially underappreciated role in CVD prevention, these efforts could prove worthwhile for the companies and their future patients.

Cleerly Brings the Confidence to Compete

Pro triathlete Timothy O’Donnell recently spoke on the Rich Roll Podcast about surviving a heart attack mid-race and how getting a Cleerly analysis gave him confidence to compete again. Once he confirmed his heart was ready, he returned to racing and went on to win an Ironman at the age of 42.

Optimizing Your Post-Processing Workflow

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.

The Wire

• CCTA Misses Small Plaques: A small study found that CCTA misses small plaques that are visible on optical coherence tomography. Using OCT for reference, researchers analyzed 40 chest pain patients’ CCTAs, finding mostly strong results: sensitivity (92%), specificity (98%), positive predictive value (99%), and accuracy (93%). But of 188 plaques identified by OCT, CCTA missed 16 for an 84% negative predictive value, largely due to challenges with sub-millimeter plaques that likely represent very early atherosclerosis.

• Agios Acquires Potential PV Treatment: Agios Pharmaceuticals acquired the exclusive global rights to develop and commercialize Alnylam Pharmaceuticals’ novel preclinical siRNA targeting TMPRSS6, which could be used to treat patients with polycythemia vera (PV). PV is a rare hematologic disease with no disease-modifying treatments that can result in thrombosis, cardiovascular events, and death. Alnylam will receive $17.5M upfront and up to $130M depending on future development and regulatory milestones.

• Booze Boosts Blood Pressure: A new meta-analysis in Hypertension showed that even modest everyday alcohol consumption increases blood pressure. In the analysis of seven studies with 19.5k participants and a 5.3-year median follow-up, systolic BP rose by 1.25 and 4.90 mmHg with 12 grams (a standard drink) or 48 grams of alcohol in one day, while diastolic BP increased by 1.14 and 3.10 mmHg. The more alcohol consumed the more SBP rose, while DBP results were more nuanced depending on sex and location.

• RUSH & Cadence Connect Care: Rush University System for Health is partnering with Cadence to roll out a new connected care program that supports patients with hypertension, congestive heart failure, and type 2 diabetes. The program combines remote monitoring tech with an NP-led care team, allowing Cadence to respond to patient vitals in real-time while alerting RUSH clinicians if needed. Cadence also provides in-home medication management, labs, and coaching, which all-together has demonstrated a 21% decrease in total cost of care for CHF patients.

• Predicting PVC Cardiomyopathy with ECG AI: Mount Sinai Health System researchers developed a new deep learning method that uses ECG results to predict which patients with premature ventricular complexes (PVCs) will develop cardiomyopathy. They used 369k ECGs for AI training and development, and tested it against ECGs from 14k patients (22.9% of whom developed LVEF ≤40% within 6 months). The AI model predicted which patients would develop LVEF ≤40% with a 0.79 AUC using internal data and an 0.85 AUC with external data.

• Weight Loss Drug Drawbacks: A KFF Health Tracking Poll found that nearly half of adults would be interested in taking prescription weight loss drugs, but far fewer would be open to them after reading the fine print. Only 23% would be interested in using a weight loss drug if it had to be taken by injection, 16% if it wasn’t FDA approved specifically for weight loss, 15% if their health plan didn’t cover the cost, and 14% if they might gain the weight back after stopping use.

• U.S. Physician Census Takeaways: The latest FSMB census of licensed physicians in the U.S. answers just about every demographic question you could have about the nation’s 1,044,734 doctors as of 2022. Some high level takeaways were that the total physician workforce grew 23% over the last decade, with women doctors now comprising 37% of the total (up from 30% in 2010). State medical boards issued a record high of 129k new licenses in 2022 (up 27% from 2020), a trend driven predominantly by expanded telehealth use throughout the pandemic. 

• Biosense Webster Goes Zero-Fluoro: Six of Biosense Webster’s AFib ablation products have received FDA approval for use in zero-fluoroscopy workflows that rely on direct imaging guidance (e.g. ultrasound). The announcement highlighted this new use case’s potential to cut radiation exposure to patients and care teams, and reduce strain associated with wearing lead aprons during procedures. The Biosense Webster ablation catheters, mapping catheters, and guiding sheaths are the first AFib ablation products to gain FDA approval for use without fluoroscopy. 

• SCOT-HEART Radiation Dose: The landmark SCOT-HEART trial showed that use of CCTA in people with chest pain can reduce risk of heart attack or death. But how much extra radiation were they exposed to? A sub-analysis of 2.9k SCOT-HEART subjects found that patients in the CCTA cohort absorbed far more radiation than standard care over five years (8.1 mSv vs. 0 mSv). However, new CT technologies have reduced radiation since the first SCOT-HEART patients were scanned in 2010.

• More Support for IVUS PCI Guidance: Yet another study – this time from South Korea – has confirmed the benefits of IVUS guidance for complex PCI. Among 6k patients who underwent either IVUS or angiography-guided complex PCI procedures, IVUS-guided procedures had lower 10-year risk of cardiac death or target vessel myocardial infarction, both when used by operators who had ≥5 years of experienced with PCI (13.5% vs. 18%) and by less-experienced operators (hazard ratios: 0.779 & 0.477).

• Anteris DurAVR THV’s First ViV Implantation: Anteris Technologies announced the first successful implantation of its DurAVR THV transcatheter aortic valve in a valve-in-valve (ViV) procedure. The ViV procedure was performed by Institut de Cardiologie de Montreal on a 84-year-old man with a failed SAVR, and was made possible by Health Canada’s Special Access Program, which permits the use of medical technologies that aren’t commercially available when it’s a life-saving situation.

Calling all Fellows! Register now for a live webinar with Dr. Hemal Gada on August 8

Join us on August 8 at 7:30 pm ET for an informative webinar designed exclusively for fellows with distinguished expert, Dr. Hemal Gada. Over the course of 55 minutes, Dr. Gada will provide a comprehensive step-by-step review of the Cusp Overlap Technique. Register now!

Start Measuring What Matters

Looking to optimize your cardiovascular imaging services, but don’t know what to measure? Check out this Change Healthcare report for insights on how to track and evaluate your cardiovascular imaging performance, assess quality, and enhance operational efficiency. Read the full article now and start measuring what matters!

The Resource Wire

• HeartFlow made its mark at SCCT 2023, announcing its new HeartFlow ONE all-in-one portfolio and releasing a trio of studies that highlight its ability to assess plaque, improve care decision making, and improve CCTA reading efficiency. 

• The expansion of remote cardiac patient monitoring is creating more care opportunities, but also new operational challenges for cardiology teams. Check out this Cardiac Wire Show, where ARTELLA Solutions’ Jacinta Fitzsimons shares how the right combination of technology and service can help physicians get the most out of their cardiac RPM programs – today and into the future.

• The University College London National Amyloidosis Centre is the world’s largest cardiac amyloidosis care provider, making their echo assessments both crucial and high-labor. See how UCL researchers used Us2.ai’s AI echo software to accurately analyze echos from 1,200 patients with ATTR Amyloidosis in 24 hours, without requiring human interaction.