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CHICAGO -- Updated national lipid guidelines present an algorithm for when to reach for a PCSK9 inhibitor and revise risk assessment in primary prevention.

The PCSK9 inhibitors were recommended by the American Heart Association (AHA) and American College of Cardiology (ACC) as "reasonable" for very high-risk atherosclerotic cardiovascular disease patients with multiple prior major events or a single such event plus multiple high-risk conditions when low-density lipoprotein (LDL) is 70 mg/dL or higher on maximally tolerated statin and ezetimibe (Zetia) therapy.

The class also got "may be considered" status for primary hypercholesterolemia regardless of 10-year atherosclerotic cardiovascular disease risk if LDL starts at 190 mg/dL or greater and doesn't drop below 100 mg/dL on a high-intensity statin plus ezetimibe and remains ≥100 mg/dL and the patient has multiple factors that increase risk.

"Ezetimibe is much less expensive, so we want people to try that first," noted Donald Lloyd-Jones, MD, of Northwestern University and a co-author of the guidelines released here at the AHA meeting and published simultaneously online in Circulation.

The other big change in the guidelines was in risk assessment for lipid-lowering primary prevention in people without diabetes.

It's the same risk-pooled cohort equations and calculator that were so controversial when released in 2013, "but we use it in a much more sequential way that gets to much better answers," noted Lloyd-Jones in an interview with MedPage Today. "Between the risk-enhancing things and the coronary calcium scanning, we're going to be much smarter about who should and should not be on a statin."

He and his colleagues dug into concerns of overestimation of risk with those tools in a special report published alongside the guidelines in Circulation. They found nuance.

"In the broad clinical population, they actually seem to be well calibrated," he said. "In patients in groups where they are high socioeconomic status or they're very engaged with the healthcare system, [the guidelines] do overestimate risk. But then in other groups that have lower socioeconomic status or diseases like HIV or rheumatoid arthritis, they actually underestimate risk."

Thus, the guidelines recommended to personalize the discussion for adults ages 40 to 75 before starting statins for primary prevention, with review of major risk factors including 10-year atherosclerotic cardiovascular disease risk calculation, comorbidities and history that could play a role, potential for adverse effects, costs, and patient preferences and values.

Coronary artery calcium (CAC) scans got a boost from a 2b recommendation to now a 2a endorsement for an intermediate-risk group: adults 40 to 75 years of age without diabetes, with LDL in the 70 to 189 mg/dL range, at a 10-year atherosclerotic cardiovascular disease (ASCVD) risk of 7.5% to 19.9%, if the decision about statin therapy is uncertain.

"If CAC is zero, treatment with statin therapy may be withheld or delayed, except in cigarette smokers, those with diabetes mellitus, and those with a strong family history of premature ASCVD," the document said.

That's actually about half of this large indeterminate group, Lloyd-Jones noted.

While the U.S. Preventive Services Task Force opted earlier this year not to back CAC scans for cardiovascular risk assessment in asymptomatic people due to insufficient evidence supporting a clinical endpoint benefit, the observational evidence was enough for the AHA/ACC. "We know what statins can do for those people in terms of reducing risk," Lloyd-Jones said.

"My personal hope is that that will push payers to start to cover this, because that has been a long time coming."

Additional groups that endorsed the recommendations were the American Association of Cardiovascular and Pulmonary Rehabilitation, American Academy of Physician Assistants, Association of Black Cardiologists, American College of Preventive Medicine, American Diabetes Association, American Geriatrics Society, American Pharmacists Association, American Society for Preventive Cardiology, National Lipid Association, and Preventive Cardiovascular Nurses Association.

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