Deepak L. Bhatt, MD after finding that most adults with CAD have above-target LDL-C levels and many aren’t being treated.

Cardiology Pharmaceuticals

Cholesterol Control Falls Short in CAD Patients

For years we’ve known that controlling LDL cholesterol lowers the risk of future cardiovascular events in people with coronary artery disease. And yet, a new JAMA paper reveals that most CAD patients fail to meet recommended cholesterol targets, and many of them still aren’t taking LDL-lowering medications.

Researchers analyzed data from 472 US adults with CAD (2015-2020, 64yr avg age, 40.5% women), finding that…

• Only 67.9% were on statins, and just 6.4% are taking ezetimibe
• A whopping 73.5% had LDL-C levels at or above the 70 mg/dL target (94.4 mg/dL avg.)
• Non-statin-takers were burdened with 120.4 mg/d average LDL-C levels 
• Even statin-takers were above target, with 82.2 mg/dL average LDL-C levels

In other words, we have a lot of room to improve LDL control, perhaps starting with guideline adherence, since the ACC/AHA guidelines recommend that…

• All ASCVD patients are treated with statins
• Higher risk ASCVD patients with LDL-C levels at or above 70 mg/dL also take ezetimibe or a PCSK9 inhibitor 

Noting that low generic costs for statins and ezetimibe eliminate typical economic barriers, an TCTMD interview with lead author Deepak Bhatt, MD, MPH theorized that our LDL-C control challenges are due to other factors…

• The need for more patient and physician education
• Concerns about statin side effects, “whether real or perceived”
• Low use of ezetimibe or PCSK9 inhibitors among the “truly statin intolerant”
• Reduced ezetimibe marketing since generics became available

The study authors also outlined some straightforward solutions including, increasing statin prescription rates and titrating doses, increasing the use of add-on and novel therapies (ezetimibe, PCSK9i / bempedoic acid), and developing mechanisms to better monitor LDL-C control and therapy adherence.

The Takeaway

There’s never been more clinically-proven, guideline-supported, and (mostly) inexpensive options for LDL-C reduction — and statins are already the most prescribed group of drugs in the United States. The fact that we’re still falling way short in controlling CAD patients’ LDL cholesterol, despite all that, might suggest that the US’ LDL-C control problem is the result of a far greater and more complex guidelines adherence problem.

Staging Coronary Artery Disease

Believe it or not, there’s been no clinically relevant atherosclerosis staging system used to characterize heart disease — until now. Check out Cleerly’s four-stage system for evaluating atherosclerotic plaque burden, which is the direct cause of coronary artery disease (CAD).

PIA’s Post-Processing Solution

Advanced cardiac imaging often calls for a time-consuming post-processing step, requiring costly software, hardware, and training. See how PIA provides this post-processing at lower cost, improved consistency, and greater efficiency.

The Wire

• FDA Reverses Paclitaxel Warning: Four years after warning physicians that paclitaxel-coated balloons and paclitaxel-eluting stents used to treat PAD might increase mortality risks, the FDA notified providers that it now believes the treatments don’t come with higher risks. The agency issued its original warning in the wake of a concerning 2018 meta-analysis, but is now satisfied with the safety of the paclitaxel-coated/eluding devices following the emergence of additional trial data.

• Leqvio’s Primary Prevention Expansion: The FDA expanded Novartis’ Leqvio (inclisiran) indication to include primary prevention among adults with high LDL-C who are taking statins and are at increased risk of heart disease, but haven’t experienced a CV event. The updated label expands the injectable LDL-lowering agent to a larger and earlier-stage patient population, adding to its late 2021 approval for people with ASCVD and heterozygous familial hypercholesterolemia (HeFH).

• Starting DOACs Early May Influence Post-Stroke Risks: People with AF who have a stroke may benefit from starting direct oral anticoagulants (DOACs) sooner after a stroke (within 48 hours after minor/moderate stroke or on day 6-7 after major stroke) rather than later (day 3-4 after a minor stroke, day 6-7 after a moderate stroke, or day 12-14 after a major stroke). The study conducted across 103 sites in 15 countries found that those who started DOACs early had lower rates of adverse events (2.9% vs. 4.1%). 

• Canadian Dipyridamole Shortage: Canada is facing a severe dipyridamole shortage due to production delays, causing Fresenius Kabi to reduce deliveries to 50% of historical order volumes through mid-August. The shortage could create cardiac imaging challenges, noting that patients who can’t participate in traditional myocardial perfusion imaging stress tests are administered dipyridamole to replicate the effect of exercise. Canadian cardiology teams have also been dealing with a nitroglycerin spray shortage.

• Comparing SAPIEN 3 TAVR & SAVR: A JACC study showed that Edwards Lifesciences’ newer SAPIEN 3 (S3) TAVR achieved 5-year death and stroke rates that are comparable to SAVR. Researchers analyzed 783 matched pairs of patients with severe aortic stenosis, finding that S3 TAVR and SAVR had similar death and disabling stroke rates, both as a composite endpoint (40.2% vs 42.7%) and when measured separately (39.2% vs. 41.4 & 5.8% vs. 7.9%). The authors suggested that follow-ups beyond 5 years are still needed to evaluate late adverse events and valve durability.

• AccurKardia’s FDA Clearance: AccurKardia announced the FDA 510(k) clearance of its flagship AccurECG Analysis System. The cloud-based and device-agnostic ECG interpretation platform supports a range of monitoring metrics (beat-by-beat, ventricular/supraventricular ectopic beat detection, heart rate, and 13 different heart rhythms), and will be offered to device manufacturers, cardiac monitoring companies, and telehealth providers with the goal of speeding up ECG analysis and patient treatment times.

• P2Y12 Inhibitors Outperform Aspirin: A new meta-analysis (n=24.3k) in JACC suggests that it may be time to phase out aspirin as a go-to blood-thinning agent for CAD patients. The authors compared aspirin to P2Y12 inhibitors, evaluating how well they each prevented issues like strokes, heart attacks, and CV death, while simultaneously minimizing serious bleeding events (blood-thinners’ Achilles heel). Over a two-year period, patients taking P2Y12 inhibitors were less likely to experience major adverse events (HR: 0.88) and major bleeding (HR: 0.87) than those taking aspirin.

• Sweat-Based Heart Monitoring: YOPI Technologies completed development of its unique wrist wearable, which analyzes electrolytes in wearers’ sweat to monitor oxygen consumption (aka VO2) for signs of “heart deterioration.” The Israeli startup is now ramping up manufacturing, targeting mass production in early 2024. This might seem like a far-out approach to some readers, but we’re seeing a growing number of wearable players seeking ways to calculate VO2 (including Apple), with some positioning their devices as alternatives to in-clinic cardiopulmonary exercise tests.

• NAHC Sues Over Home Health Cuts: The National Association for Home Care and Hospice is already suing the HHS and CMS over the $375M in cuts included in last week’s proposed rule for 2024 home health reimbursement. The litigation arrives after Congress directed CMS to change Medicare reimbursements to a “budget-neutral” methodology that looks at complexity of care as opposed to number of therapy sessions. NAHC alleges that regulators are violating Congress’ orders by continuing to tie reimbursement to the amount of therapy provided, resulting in lower home health expenditures.

• ML Uncovers Five Distinct HF Subtypes: Researchers in London used AI to identify five different types of heart failure, paving the way for more precise prognosis and treatment decisions. The authors leveraged data from over 300k adults with HF. Using four ML methods to analyze 87 different factors, they identified five HF categories: 1) early onset, 2) late onset, 3) AF related, 4) metabolic, and 5) cardiometabolic. The researchers have already developed a prototype app that doctors could use to easily evaluate the clinical and cost-effectiveness of different treatments.

• Hospital Margins Continue to Stabilize: Kaufman Hall’s latest figures showed that hospital margins continue to stabilize after spending most of the year in the red, with median margins ticking up from 0.1% in April to 0.3% in May. Operating revenue climbed 2% month-over-month (up 9% on-year), driven by both outpatient (+14%) and inpatient services (+6%). Labor expenses provided some relief as well, falling 1% since April to offset an equal increase in supply and drug expenses.

Register Now: Current TAVR Trends for Bicuspid Anatomy on July 17.

Join our expert faculty for a live, case-based discussion on July 17 at 7:30 p.m. ET. Over the course of 90 minutes, we will discuss strategies for bicuspid cases and contemporary sizing methods. Register now!

Overcoming Cardiovascular Data Challenges

Aggregating multisource cardiology data is a worthy mission, but it’s often thwarted by confusion and complexity. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, outlines best practices to help you overcome your cardiology data challenges and start leveraging deeper insights.

The Resource Wire

• HeartFlow’s PRECISE trial showed that their precision approach for evaluating stable chest pain avoids unnecessary testing and improves care – without risking missed heart disease diagnoses. In this Cardiac Wire Show, HeartFlow’s Chief Medical Officer Dr. Campbell Rogers dives into the PRECISE trial results and its implications for clinical practice.

• Monebo’s Kinitec Rhythms ECG Algorithm separates true ECG signals from background noise, leading to more accurate diagnoses and improved operator efficiency. See for yourself how the algorithm measured up to a gold standard.

• Us2.ai published what might be the most comprehensive paper we’ve seen on AI echo, detailing the benefits of AI-automated echocardiography, the global need for more scalable and flexible CVD assessments, and how its technology is fit for the future. If you’re focused on the echo, echo AI, or echo accessibility and efficiency, this paper is worth checking out.