A tweet from Eric Topol, MD

Cardiology Pharmaceuticals

Amgen’s Olpasiran Slashes Lp(a) Levels

The Ocean(a)-DOSE trial made a splash at AHA this year, providing new insight into olpasiran’s potential to reduce Lp(a) levels in patients with ASCVD. In the phase 2 trial, 75 mg or more of the Amgen siRNA therapy delivered at least every three months basically obliterated Lp(a) levels. 

There is currently no FDA-approved therapy for reducing Lp(a), despite a large body of evidence linking high levels of the cholesterol-carrying lipoprotein to ASCVD. And because Lp(a) levels are almost entirely genetic (as opposed to being dictated by lifestyle choices), pharmaceutical companies are eager to develop a remedy. Olpasiran is now one of only a handful of drugs in development that fit the bill. 

In the study, researchers randomized 281 people with ASCVD and high Lp(a) serum levels to receive one of four doses of olpasiran:

• 10 mg every 12 weeks
• 75 mg every 12 weeks
• 225 mg every 12 weeks
• 225 mg every 24 weeks

At 36 weeks, the Lp(a) concentration had increased by 3.6% in the placebo group, while Lp(a)  levels were almost eliminated in the olpasiran group: 

• 10 mg every 12 weeks – Lp(a) decreased by 70.5%
• 75 mg every 12 weeks – Lp(a) decreased by 97.4%
• 225 mg every 12 weeks – Lp(a) decreased by 101.1%
• 225 mg every 24 weeks – Lp(a) decreased by 100.5% 

The drug is safe, too. The incidence of adverse events was similar across trial groups and to placebo, with the most common olpasiran-related adverse event being mild injection site reaction.

This is a key milestone following Amgen’s acquisition of olpasiran in 2020 from Arrowhead Pharmaceuticals. Armed with these encouraging phase 2 results, Amgen plans to launch a 6k person phase 3 pivotal trial this December. 

The Takeaway

Phase 2 trial results suggest Amgen’s experimental siRNA therapeutic olpasiran is safe and leads to “profound and sustained” Lp(a) reductions in people with ASCVD. The findings provide a strong foundation for Amgen’s phase 3 testing, scheduled to begin later this year.

Making Echo Accurate, Efficient, and Accessible

Check out this Imaging Wire Show featuring Us2.ai’s co-founders – James Hare and Dr. Carolyn Lam – for a great discussion about Us2.ai’s continued clinical and commercial expansion, and their efforts to improve echocardiography accuracy, efficiency, and accessibility.

The HeartFlow Story

Shifting the standard of care is a monumental undertaking, and yet physicians across the globe are embracing HeartFlow’s FFRct Analysis. Hear from the co-founder how HeartFlow got its start, and why physicians love it.  

The Wire

• HeartFlow’s PRECISE Outcomes: For patients with stable symptoms and suspected coronary artery disease, HeartFlow’s coronary CTA + FFRct strategy resulted in a four-fold reduction in unnecessary referrals to the cath lab, compared to traditional approaches. That’s from a randomized clinical trial (N=2.1k) that found that providers who used HeartFlow’s Precision Pathway FFRct solution were 75% more likely to identify patients in need of intervention. The FFRct Analysis uses AI coupled with highly trained analysts to create an interactive 3D model that quantifies blood flow and blockages.

• Inclisiran’s Sustained LDL-C Effect: Novartis’ cholesterol drug inclisiran (Leqvio) consistently and safely helped patients lower their “bad” cholesterol. The phase II extension ORION-3 trial (N = 233) found that twice-yearly inclisaran injections as a complement to statin therapy provided “effective and sustained” reductions in LDL-C over four years of treatment, with a time-averaged reduction of 44.2%. At any point throughout the trial, 80% of patients reached an LDL-C level under 70mg/dL². The safety-benefit profile was consistent with findings from 18-month phase III trials.

• Anumana Acquires NeuTrace: The Mayo Clinic spinout and Nference company Anumana has acquired NeuTrace, giving Anumana a comprehensive electrophysiology deep-learning development platform and product pipeline. Anumana’s AI-guided screening approach leverages existing ECG data to identify previously unrecognized AFib. The acquisition includes the NeuTrace EP Data Biome platform and a portfolio of EP software applications (in development). Building on recent partnerships with Novartis, the acquisition solidifies Anumana as a leader in the AI EP software development sphere. 

• Mindfulness Intervention to Lower BP: A new study of over 200 adults showed that mindfulness may help lower blood pressure. Participants of an 8-week mindfulness-based program saw greater reductions in systolic blood pressure at six months compared to those who only received health education material (5.9 mmHg vs. 1.4 mmHg).  

• Healthcare Lobbying Up 70%: New research in JAMA showed that healthcare lobbying spending rose 70% over the past two decades, with U.S. lobbying expenditures totaling almost $714M in 2020 (up from $358M in 2000). Lobbying increases were driven primarily by pharmaceutical companies, device manufacturers, and healthcare providers. Lobbying was also extremely concentrated, as the top 10% of firms were responsible for 70% of payor lobbying, 69% of manufacturer lobbying, and 59% of provider lobbying.

• iRhythm Cost Effectiveness: An economic analysis of a 2018 randomized clinical trial found that systematic screening for AFib with iRhythm’s FDA-cleared Zio XT patch is cost-effective. In a three-year study of 2.7k at-risk individuals, those prescribed the Zio XT heart monitor patch were less likely to visit the ED or require hospitalization, contributing to an incremental cost-effectiveness ratio of $17k per quality-adjusted life year gained.

• Viz.ai Launches Cardio Suite: Viz.ai launched its new Viz Cardio Suite, combining its existing cardiology AI tools (PE detection, aortic disease detection, Us2.ai’s echo AI reporting) and new mobile ECG and mobile/web cardiac imaging viewers, with Viz.ai’s trademark care coordination capabilities (in-app cardiology consultation, CVIS and EHR patient data acquisition). The Cardio Suite is a milestone for Viz.ai, which established its business in neuro care coordination, and has been building out its cardiology-related capabilities over the last year. 

• CRISPR Therapy Reduced TTR Expression: A clinical trial found that a single infusion of NTLA-2001, a CRISPR-based therapy, reduced transthyretin (TTR) by over 90% among people with the progressive and fatal TTR amyloidosis with cardiomyopathy disease (ATTR-CM). In the study, 12 patients with ATTR-CM received a single intravenous dose of the gene-editing construct. All patients achieved ≥90% TTR reduction by day 28, and maintained that benefit through six months.  

• September Hospital Margins: Hospitals continued to operate in the red during September, with Kauffman Hall’s latest National Flash Report showing that we’re now in our tenth straight month of negative operating margins. Hospital margins stand at -0.1% through September, with slight expense decreases doing little to offset a 3% month-over-month decline in admissions, ED visits, and patient days.

• Cardiovascular POCUS in COVID Patients: Performing cardiovascular point-of-care ultrasound (POCUS) – rather than lung ultrasound alone – may help identify COVID patients with severe lung and thrombotic involvement. Researchers performed lung, cardiac, and deep vein POCUS in 178 COVID patients within one hour of ICU admission. Lung ultrasound score over 13, low ejection fraction, and thrombosis in either vein each independently yielded a high sensitivity for mortality (93.5%, 92.3%, and 96.5%). When researchers combined information from both the heart and lungs, sensitivity for mortality improved to 96.7%. 

• Patient Experience & Loyalty: An Accenture survey showed that patient experience is more important than ever, with 25% of surveyed patients leaving their providers in search of a better fit in 2021. The 21k-person survey uncovered four factors that patients ranked as most important to their loyalty: location and availability (71%), digital engagement options (79%), ease of doing business (82%), and provider trust (84%). 

Defining Heart Disease 

AHA 2022 brought another reminder that Cleerly is ushering the field of cardiology away from population-based estimates into precision heart care. Take a peek at research underway that demonstrates how Cleerly leverages CTA and AI analysis to identify lipid-rich plaque and high-risk arterial buildup. 

Protecting Your Cardiovascular Imaging Data

Are you sure about your cardiovascular imaging data security? Tune-in to this Change Healthcare webinar discussing how hospital systems and healthcare providers can strategically improve their data security.