Unmet LDL-C Goals Common in ASCVD: PINNACLE, NHANES

Marlene Busko

November 26, 2019

Lipid lowering for the secondary prevention of cardiovascular disease (CVD) events in patients with atherosclerotic cardiovascular disease (ASCVD) needs improvement, two new studies conclude.

In one study, presented at the American Heart Association (AHA) Scientific Sessions 2019 in Philadelphia, Pennsylvania, Joseph Allen, MA, Decision Sciences, American College of Cardiology (ACC), and colleagues report that "large gaps exist" in guideline-recommended low-density cholesterol (LDL-C) goal achievement among ASCVD patients.

That analysis was based on data from outpatients who had had a prior ASCVD event and were part of the US PINNACLE registry from 2013 to March 2019.

In a separate study published online in the Journal of the American College of Cardiology, Nirav Patel, MD, University of Alabama at Birmingham, and colleagues report that an analysis of National Health and Nutrition Examination Survey (NHANES) data of US adults in the community from 2005/2006 to 2015/2016 showed that although statin use trended upward, it was suboptimal — including use in the subgroup of patients with clinical ASCVD who were comparable to the patients in the PINNACLE registry.

Both studies show that "there are opportunities for improvement," Pankaj Arora, MD, University of Alabama at Birmingham, told theheart.org | Medscape Cardiology.

Arora is senior author of the study based on NHANES data, which investigated trends in lipids, lipoproteins, and statin use among US adults, to examine the impact of the 2013 ACC/AHA cholesterol guidelines. Those guidelines advise a "risk-based approach" rather than the previous "titration to goal LDL-C level."

He added: "Whether those are educational opportunities at the patient level alluding to their fear of taking a statin, or whether there are educational opportunities at the healthcare provider level, there are clear interventions targeting these gaps that can be taken to help improve the dissemination of the 2013 ACC/AHA guidelines."

The two studies were conducted in different populations — NHANES is a community-based sample that included some people with ASCVD, whereas PINNACLE is a large national registry solely of patients with established ASCVD, he noted.

The senior author of the study based on PINNACLE data, Dharam J. Kumbhani, MD, UT Southwestern Medical Center, Dallas, Texas, made the same point to theheart.org | Medscape Cardiology. "Overall, though," he said, "both show a large burden of non- and undertreatment in ASCVD patients, and further efforts to address these gaps are essential."

PINNACLE: Phase 1 of TRANSFORM LDL-C Risk Initiative

The analysis based on PINNACLE registry data from 2013 to 2019 included data from the past 4 years, after two PCSK9 inhibitors were approved by the US Food and Drug Administration: alirocumab (Praluent, Sanofi/Regeneron) in July 2015, and evolocumab (Repatha, Amgen) in August 2015.

This study is the first phase of a national program — TRANSFORM LDL-C Risk — developed through a partnership between the ACC, Sanofi, and Regeneron, as explained in an April 2019 statement issued by the ACC.

According to the statement, "TRANSFORM LDL-C Risk will leverage ACC's PINNACLE Registry to identify patients with established ASCVD, many of whom will qualify as 'very high risk' as defined by the 2018 ACC/AHA Guideline on the Management of Blood Cholesterol, in select sites across multiple regions in the US and who meet the evidence-based criteria for enhanced treatments."

The researchers aimed to examine goal attainment (LDL-C <70 mg/dL) in adults in the PINNACLE registry.

They identified 1,897,204 patients aged 18 years or older who had established ASCVD, defined as acute coronary syndromes, or a history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease that was presumed to be of atherosclerotic origin.

Of these patients, 21.1% were not receiving any lipid-lowering therapy, and 70.0% were receiving statin monotherapy.

The remaining 8.9% were mostly receiving ezetimibe with or without a statin. Only about 1% to 2% of these patients were receiving a PCSK9 inhibitor, Kumbhani said.

Among the patients who were not receiving any lipid-lowering therapy, only 15.8% met the goal of LDL-C <70 mg/dL.

Among the patients who were receiving a statin, only 32.9% met the goal of LDL-C <70 mg/dL; for another 41.1%, LDL-C was 70 to 99 mg/dL; and for the remaining 25.9%, LDL-C was ≥100 mg/dL.

Younger patients (18 to 64 years old), women, and African American participants were somewhat less likely than older patients, men, and white participants to have an LDL-C <70 mg/dL.

For a similar percentage of patients with heart failure, type 2 diabetes, atrial fibrillation, or chronic kidney disease (slightly above 40%), LDL-C was <70 mg/dL, whereas fewer patients with hypertension (about 40%) met this target level of LDL-C.

Not all patients who should be taking lipid-lowering therapy, as determined on the basis of guidelines, were receiving it, Kumbhani summarized. Of those who were receiving a statin alone for lipid lowering, only a third met the goal of LDL-C <70 mg/dL.

"Future studies should examine barriers and activators for change and factors associated with achieving standards-based care goals," the authors conclude.

Lipid Levels, Statin Use Before, After 2013 Guidelines

In their separate analysis, Patel and colleagues sought to determine changes in awareness of having high cholesterol and use of statin therapy before and after release of the 2013 ACC/AHA cholesterol guidelines.

They identified 32,278 adults aged 20 years or older who participated in NHANES 2005/2006 through 2015/2016.

Among the adults who reported taking a lipid-lowering medication from 2005/2006 to 2015/2016:

  • mean total cholesterol decreased from 206 mg/dL to 187 mg/dL;

  • age-adjusted mean LDL-C decreased from 122 mg/dL to 101 mg/dL; and

  • triglycerides decreased from 176 mg/dL to 122 mg/dL.

Levels of HDL-C did not change during the study period.

Among US adults who were eligible to receive a statin, the proportion who reported that they had been told their cholesterol level was high (awareness of high cholesterol) increased from 64% in 2005/2006 to 69% in 2011/2012 through 2015/2016.

The proportion who were taking a statin increased from 41% to 49% during the study.

Among adults with diabetes, around 74% were aware that they had high cholesterol, and statin use increased from 48% to 60%.

Among adults with a 10-year predicted ASCVD risk ≥7.5%, the proportion who were taking a statin increased from 28% in 2005/2006 to 37% in 2013/2014 and then decreased to 33% in 2015/2016.

The study documents a "continued decline" in lipid and lipoprotein levels following the publication of the 2013 cholesterol guidelines, the authors summarize, especially among adults who were taking a lipid-lowering medication.

At the same time, awareness of high cholesterol levels has remained stable.

Notably, among the NHANES participants with diabetes, statin use increased during this period.

By 2011/2012, 64% of participants with clinical ASCVD were taking a statin, as were 43% of participants with type 2 diabetes and 27% of patients whose 10-year ASCVD risk was >7.5%

"Statins are still underutilized (<50%) with no change in statin use before and after publication of the 2013 guidelines," the authors summarize.

The analysis is still relevant, they note, since "the updated [2018] AHA/ACC cholesterol guidelines proffer a similar risk-based approach that we used in the current study."

The TRANSFORM LDL-C Risk Initiative was supported by Sanofi-Regeneron. Among the authors of the NHANES-data-based study, Patel reports that he is supported by a National Institutes of Health grant; Arora is supported by a National Institutes of Health Mentored Patient-Oriented Research Award; and a study author has received research grant support from Amgen. The other authors have disclosed no relevant financial relationships.

American Heart Association (AHA) Scientific Sessions 2019: Presented November 17, 2019.

J Am Coll Cardiol. Published online November 11, 2019. Abstract

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