Sensible Medicine’s Adam Cifu, MD, after a study backed by four pharma companies with testosterone therapy businesses found that TRT doesn’t increase CVD risks.

Cardiology Pharmaceuticals

Two Sides to Bempedoic Acid’s Primary Prevention Impact

A Cleveland Clinic-led study stunned the ADA 2023 crowd this week, showing that bempedoic acid (Esperion’s Nexletol) significantly reduced future cardiovascular events among people with high CVD risks who had never experienced a major cardiac event. 

The JAMA-published subanalysis of the 14k-patient CLEAR Outcomes trial looked at a subgroup 4,206 primary prevention patients (high CVD risks, diabetes, no previous CV events, statin-intolerant, 59% women) who were randomized to either take bempedoic acid (180 mg daily oral) or a placebo.

The bempedoic acid group achieved a 21.3% average LDL-C reduction versus placebo at six months (-30.2 mg/dL, 142.5 mg/dL at baseline), and had 21.5% lower HSCRP levels at 12 months (2.4 mg/L at baseline). 

Those “modest” cholesterol reductions appeared to drive significant outcome improvements over 40 months:

• 30% reduced risk of MACE 4 (5.3% vs 7.6% – CV death, MI, stroke, or coronary revascularization) — the primary endpoint
• 36% reduced risk of MACE 3 (4.0% vs. 6.4% – CV death, MI, or stroke)
• 39% reduced risk of nonfatal myocardial infarction (1.4% vs. 2.2%)
• 39% reduced risk of cardiovascular death (1.8% vs. 3.1%)
• 27% reduced risk of all-cause mortality (3.6% vs. 5.2%)

These subanalysis results far surpassed those from the overall CLEAR Outcomes trial, which showed a much smaller 13% reduction in MACE 4 among both primary and secondary prevention patients, and didn’t reduce all-cause mortality.

The authors called the study a “wake-up call” for physicians, noting that less than half of U.S. adults who are candidates for primary prevention lipid-lowering therapy actually receive it, including many patients who can’t or don’t want to take statins.

However, the corresponding JAMA editorial and critics on CardioTwitter suggest that these results might be “too good to be true” (e.g. statistical issues, implausible differences from CLEAR trial results), and the editorial emphasized that bempedoic acid should be viewed as a “good plan B” rather than a statin substitute. 

The Takeaway

At least within this particular subanalysis group, bempedoic acid massively reduced high-risk patients’ risk of experiencing their first CV event, while underscoring the overall importance of primary LDL-C reduction (regardless of medication). 

However, commentary from study authors and the cardiology community suggests that it might take even stronger evidence and some big changes (new guidelines, lower costs, more education/outreach) in order to meaningfully expand adoption of preventative LDL-C reduction therapies — especially beyond statins.

Imaging AI + Calcium Scoring for Heart Attack Prevention

See how CCTA AI combines with CAC scoring to transform preventive heart care in this on-demand webinar featuring world-renowned prevention expert Dr. Arthur Agatston (author of the South Beach Diet, creator of the Agatston score), Cleerly founder Dr. James Min, and CMO Dr. James P. Earls.

Automating Echo Amyloidosis Assessments

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.

PRECISE Trial Rewrites the Patient Pathway

HeartFlow’s landmark PRECISE trial found that their precision approach for evaluating people with stable chest pain avoided unnecessary testing and improved care without putting patients at risk of a missed heart disease diagnosis.

The Wire

• Shopping Cart Afib Screening: UK researchers found that supermarket shopping carts (or “trolleys” over there) could be used to screen for undiagnosed atrial fibrillation during people’s daily routines. Among 2,155 adults who used the AF screening shopping carts, 220 were flagged by the carts or an on-site pharmacist, and 59 were later diagnosed with AF (39 previously undetected). Although better accuracy will be required, the authors highlighted the benefits for those 39 participants, and the “promise” of shopping cart AF screening.

• Sensible’s TRT Takedown: A recent NEJM study found that testosterone-replacement therapy doesn’t increase CV event risks among men with preexisting CVD or a high risk of CVD, earning widespread media coverage and an unenviable spot as Sensible Medicine’s Study of the Week. In addition to Sensible Medicine author Adam Cifu, MD’s problems with TRT (overprescribed, overmarketed, cosmetic etc), he noted that the study’s treatment group had “remarkably small” testosterone increases and 61% stopped their medication, so he still doesn’t know whether TRT is safe. However, he does know that the study was backed by four TRT pharma companies.

• Ultrasight & EchoNous’ Echo Guidance Alliance: With an eye on expanding echo use beyond sonographers and into new clinical settings, UltraSight and EchoNous launched an alliance that will make UltraSight’s AI-based echo guidance software available with EchoNous’ KOSMOS handheld ultrasound systems. This is UltraSight’s first major alliance since GE HealthCare acquired echo AI guidance competitor Caption Health, although UltraSight might have more handheld ultrasound partnerships on the way given its anticipated FDA clearance and the growing momentum towards increasing echo access.

• Quadruple HF Therapy’s Narrow Cost-Effectiveness: Quadruple therapy (QT) for HFrEF, which incorporates newer agents like ARNis and SGLT2 inhibitors, is barely cost-effective compared to older therapies. Harvard researchers found that adding both ARNi and SGLT2i to the standard regimen led to an incremental cost-effectiveness ratio of $98,500/QALY – placing QT just under the $100,000/QALY cost-effectiveness threshold. QT’s cost-effectiveness also varied considerably (from $73,500 to $110,000 QALYs) based on how well payors negotiated.

• Eko Health’s Next-Gen Smart Stethoscope: Eko Health announced the launch and FDA clearance of its CORE 500 smart stethoscope, which combines audio enhancement with AI-based heart disease detection and 3-lead ECG arrhythmia assessments (shown on stethoscope display screen). The CORE 500 is intended to increase heart disease detection at the point of care, with targeted usage across an array of care settings (primary and urgent care, emergency, home, virtual) in addition to structural heart.

• 18F-GP1 PET/CTA for Coronary Thrombosis: A team of international researchers found that coronary 18F-GP1 PET/CT angiography is the first noninvasive technique that can identify coronary thrombosis in patients with acute myocardial infarction, suggesting that the novel PET radiotracer could improve heart attack diagnosis and care decision making. The researchers performed 18F-GP1 PET/CTA on 99 patients with or without acute MI, finding that 18F-GP1 uptake was visible in 80% of culprit lesions in the MI patients.

• Flurpiridaz PET’s Obesity CAD Advantage: In other cardiac nuclear imaging news, Mount Sinai researchers found that stress cardiac PET imaging using the novel ¹⁸F-flurpiridaz radiotracer is more accurate in detecting coronary artery disease in obese patients than SPECT MPI. Among 298 obese patients, PET ¹⁸F-flurpiridaz turned in higher sensitivity (77% vs. 69.2%) and specificity (67% vs. 61.9%) than SPECT MPI, while achieving lower radiation dosage.

• CMS Proposes New Breakthrough Device Pathway: FDA-cleared “breakthrough devices”  could soon have a quicker path to reimbursement if CMS’ proposed Transitional Coverage for Emerging Technologies (TCET) pathway is enacted. With the goal of finalizing coverage within six months of FDA approval, the TCET pathway would give device makers access to CMS officials prior to FDA market authorization to review early evidence, help design studies to address payor concerns, and offer guidance on the best existing coverage areas. 

• Mavacamten’s EU Approval: Bristol Myers Squibb announced that the European Commission approved Bristol Myers Squibb’s mavacamten (Camzyos) for treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM) in adults (NYHA class II-III). Helped by its positive EXPLORER-HCM and VALOR-HCM Phase 3 trials, Mavacamten is now approved for HCM in both the U.S. (since April 2022) and across Europe.

• The ACA’s Cardiovascular Impact: The Affordable Care Act’s move to expand Medicaid eligibility in 2014 led to increased coverage of cardiovascular treatments, and improvements to CV care and outcomes. An AHA review of 30 studies found that Medicaid expansion increased coverage of CV treatments (64.3% of studies), improved CV preventative care (47.8%), and reduced CV morbidity/mortality (36.4%) and disparities in CV care (37.5%). However, no studies showed in-hospital mortality improvements.

• The ER Fireworks Show: It’s that time of year again, and Americans are getting ready for an Independence Day weekend filled with family, friends, and one of every ER doctor’s worst enemies: fireworks. Pew data shows that an average of 91k people visit US emergency rooms between July 4th and 5th, by far the highest daily numbers of the entire year (the average is under 39k ER visits). The cause of the spike probably isn’t a surprise: over half of all yearly fireworks injuries in the US are sustained in the first week of July. The report didn’t include any CV event stats, but any cardiac patients who present to EDs next week will be cared for by burdened teams.

Accurately Measuring Heart Rate Variability

Heart rate variability measurement and analysis involves two critical elements – the ability to accurately discern the R wave in noisy environments, and using the correct analysis method for a given application. Check out how Monebo’s Kinetic HRV ECG Algorithm excels at both of these essential tasks.

Making the Leap to Outsource Post-Processing

Interested in how to outsource cardiac image post-processing, but not sure where to start? PIA walks you through how to assess and compare vendors, understand pricing models and payment options, and outline your requirements to identify vendors who meet your clinical needs. 

Preparing for the Future of Cardiovascular Data and Analytics

There’s plenty of short term benefits to cardiology data analytics, but it’s just as important for providers to make sure they’re ready for the future of cardiology analytics. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, examines what technology leaders can do today to facilitate their future advancements in cardiovascular data and analytics.