LDL-C Management Trends in ASCVD Patients

Announcer:
You’re listening to Heart Matters on ReachMD, and this episode is sponsored by the Family Heart Foundation. Here’s Dr. Keith Ferdinand.

Dr. Ferdinand: 
This is Heart Matters on ReachMD. I'm Dr. Keith C. Ferdinand, Professor of Medicine and the Gerald S. Berenson Endowed Chair in Preventative Cardiology at the Tulane University School of Medicine in New Orleans, Louisiana. Today I'll be discussing an analysis of LDL-C management in patients with atherosclerotic cardiovascular disease, commonly known as ASCVD, which will be presented based on what we had at the 2024 Family Heart Foundation Global Summit. 

Let's discuss LDL-C management trends in US individuals with ASCVD during the years of 2021 to 2022. This analysis is based on the Family Heart Database of over 300 million separate claims in the United States. The particular group that we're looking at is over 3,444,000 persons with the diagnosis of ASCVD. 

The diagnosis of ASCVD in this particular registry was quite broad. We looked at persons who had an acute myocardial infarction, unstable angina, any form of intervention, whether it be percutaneous intervention or coronary bypass, any formal cerebral vascular disease, including stroke and TIA's, and peripheral arterial disease or any diagnosis related to ASCVD in our claims data. The cohort was large, robust and diverse, over 3,444,000 persons. We then were able to see, based on this particular cohort, which persons achieved an LDL-C goal of less than 70 milligrams per deciliter, or less than 55 milligrams per deciliter. We further were able to tell which patients were on monotherapy with high intensity statin or combination therapy, as suggested by guidelines, or unfortunately, which patients had either no therapy or only low to moderate intensity statin therapy. 

This was a large, diverse population. When we look at demographics and medical characteristics, it was over 3,444,000 persons. Forty-eight percent were female, 11 percent were identified as black, 11 percent as Hispanic. Most, considering their age of 69, had hypertension, and 44 percent with diabetes. Unfortunately, the mean LDL cholesterol was 90, and this would portend that some of these patients were not achieving appropriate goal of an LDL less than 70. 

In terms of the study criteria, the most important groups were those who had guideline-directed medical therapy. Recognizing that they all had a diagnosis of ASCVD, these were patients who were either on high intensity monotherapy with statins or with combination therapy. The more intense therapies would be those who were on PCSK9 inhibitors, along with statins. Unfortunately, when we look at an analysis of these data, high intensity statins was only approximately 30 percent, and combination therapy was perhaps no more than 6 to 7 percent. And even more unfortunately, 30 percent of persons, despite having a diagnosis of ASCVD, had no therapy. 

It should be recognized however, since this was claim-based data, most of the patients had some form of insurance coverage. A little bit over half had Medicare considering their age, a significant proportion with commercial insurance or Medicaid, and only about 6 to 7 percent with no coverage. This is going to be an important part of the analysis when we look at disparities related to household income and education.                         

One of the most important components of this analysis was to document in patients who had documented ASCVD, widely defined as any form of atherosclerotic cardiovascular disease, including myocardial infarction, unstable angina, interventions, either angioplasty or otherwise, with coronary bypass, peripheral arterial disease, or any form of cerebral vascular disease. In these high-risk patients, individuals who never achieved an LDL of less than 70 milligrams per deciliter was 61 percent.

One interesting way to look at these data is to look at a cohort of 100 individuals across the United States who had a diagnosis of ASCVD broadly defined, and look at the percentage of those who use guideline recommended, high intensity statin therapy or combination therapy for the full 21 to 24 months. It was only 12.7 percent. That means, out of those 100 individuals, only 13 of those 100 either had high intensity monotherapy or combination therapy for 21 to 24 months. 

One of the interesting findings of this study is that when you look at disparities of LDL-C goal attainment, they were blunted or eliminated based on household income or education. This is an important message; although goal attainment was suboptimal overall, some of the disparities that we see across the United States based on household income and education were not found in this study. But remember, over 90 percent of these patients had some form of insurance coverage for their therapy. Persons who are uninsured or underinsured are going to even be worse in their outcomes, suggesting that we need to do more to make sure that patients have access to primary care clinicians and specialists and the ability to afford medications. 

For those of you who are tuning in, you're listening to Heart Matters on ReachMD. I'm Dr. Keith C. Ferdinand, speaking about LDL-C management in patients with atherosclerotic cardiovascular disease.

These data from the Family Heart Foundation database of over 3,444,000 persons are very important. Let's look at the main highlights. It shows a lack of urgency to manage LDL-C and follow US guideline recommendations in patients who have documented ASCVD, broadly defined. Most individuals, 61 percent with ASCVD based on our data, were failing to reach an LDL-C goal of less than 70.

In our Family Heart Database, those who failed to achieve an LDL-C goal of less than 70 were more likely to be less than 50 years of age, women, or identified as black individuals. These are some areas where we especially need to target more consistent and intense LDL-C lowering. 

One of the important take-homes from this particular analysis is that although we have available strategies to lower LDL-C, we're not utilizing them. For instance, new innovative, highly effective LDL-C lowering therapies such as PCSK9 were rarely used, less than 2 percent of individuals. Combination therapy, which is an important approach to LDL-C management in these high risk patients, was also rarely used—only approximately 7 percent of patients. And patients who are on high-intensity statin was infrequent, only 30 percent of individuals.

We now recognize that combination therapy is one of the best means for LDL-C goal attainment, whether it be less than 70 or less than 55 in very high-risk patients. We need to do more to utilize medications that will robustly and intensely lower LDL-C and protect our patients. 

Finally, despite having a broad diagnosis based on claims of ASCVD, throughout 2021 and 2022, most individuals received either low or moderate intensity statin monotherapy – 31 percent - or no therapy – 30 percent. Therefore, 61 percent of patients were not using guideline-directed medical therapy—defined as high-intensity monotherapy with statins or combination therapy. This reflects the 61 percent of persons who did not achieve an LDL goal of less than 70 milligrams per deciliter.

Thank you for giving me this opportunity to present data from the Family Heart Foundation database of over 3,444,000 persons with ASCVD broadly defined. Sixty-one percent did not achieve an LDL-C goal of less than 70 milligrams per deciliter, and distressingly, 30 percent of these persons were on no lipid lowering therapy at all.

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This episode of Heart Matters was sponsored by Family Heart Foundation. To access this and other episodes in our series, visit Heart Matters on ReachMD.com, where you can Be Part of the Knowledge. Thanks for listening!