"[T]here is no longer an 'LDL-C hypothesis', but established facts that increased LDL-C values are causally related to ASCVD [atherosclerotic cardiovascular disease], and that lowering LDL particles and other ApoB-containing lipoproteins as much as possible reduces CV events," the European Society of Cardiology (ESC) and European Atherosclerosis Society guideline stated.
Revised recommendations in the document, appearing in the European Heart Journal and slated for presentation at the ESC meeting here, included:
- For secondary prevention in "very-high-risk" patients, cut LDL by at least 50% from baseline and to under 55 mg/dL (previously the goal was 70 mg/dL)
- For very-high-risk patients on maximally tolerated statin therapy with a second vascular event within 2 years (regardless of type), an LDL goal under 40 mg/dL may be considered
- Primary prevention for people with a risk factor other than familial hypercholesterolemia, at least halve LDL from baseline and reach less than 55 mg/dL
- For patients at high risk, the target was below 50% of baseline and less than 70 mg/dL (previous goal was 100 mg/dL)
- For individuals at moderate risk (calculated 10-year risk of 1% to less than 5%) or young diabetes patients without other risk factors, the goal to consider is under 100 mg/dL (previously 115 mg/dL)
- For those with a 10-year risk score under 1%, an LDL goal under 116 mg/dL should be considered
There's no lower limit for LDL or J-curve effect for efficacy, and "studies of the clinical safety of these very low achieved LDL-C values have proved reassuring," the document added.
As with the 2018 American Heart Association/American College of Cardiology (AHA/ACC) lipid guidelines, ESC upgraded PCSK9 inhibitor use from "may be considered" to "is recommended" for certain high-risk groups.
But unlike the AHA/ACC guideline, ESC suggested considering measurement of Lp(a) at least once for adults to catch inherited levels over 180 mg/dL, which may confer lifetime ASCVD risk on par with heterozygous familial hypercholesterolemia.
"Because it's stable over a lifetime, there's no need to keep redoing it," Baigent noted.
However, he cautioned that the impact of these guidelines really will depend upon the extent to which PCSK9 inhibitors are available to patients.
"Many patients will achieve their goals just using what's already available and cheap," he said. "However, where people do remain at very high risk despite being on a high-dose statin and ezetimibe [Zetia], we think that the evidence supports further reduction in LDL cholesterol, and that can only be achieved currently with PCSK9 inhibitors. We know that they are expensive, we know that there are many parts of Europe they won't be affordable, but we believe that we should reflect the available evidence in the guidelines."
The ESC also released a slate of other guidelines, including those on diabetes and pre-diabetes, acute pulmonary embolism, supraventricular tachycardia, and stable coronary artery disease -- now renamed to chronic coronary syndromes.
Baigent reported institutional research funding from Novartis, Pfizer, and Boehringer Ingelheim. Declarations of interest for the full guideline writing committee can be found here.
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