46
Management
4.2.4.3. Severe Hypercholesterolemia With LDL-C ≥190 mg/dL
(4.9 mmol/L)*
COR LOE
Recommendations
Inclisiran in Severe Hypercholesterolemia
2a B-R
6. In adults with severe hypercholesterolemia, with or
without clinical ASCVD, and LDL-C ≥100 mg/dL
(2.6 mmol/L) despite maximally tolerated statin with or
without ezetimibe therapy, treatment with inclisiran14 is
reasonable to lower
LDL-C
‡
.
* Severe hypercholesterolemia with LDL-C >190 mg/dL, non–HDL-C >220 mg/dL, and/or
apoB >140 mg/dL.
†
Clinical ASCVD includes ACS, a history of MI, stable or unstable angina, coronary or other
arterial revascularization, stroke, TIA, lower-extremity PAD or other atherosclerotic forms
of PAD, including aortic aneurysm.
‡
Cardiovascular outcomes trials are pending for inclisiran. It is indicated only to lower
LDL-C and is considered a second-line PCSK9i at this time.
(cont'd)
Table 15. Liposorber® (LA-15 System) FDA-Approved
Indications for Lipoprotein Apheresis*
Patient Group Criteria for Treatment
Group A Clinically diagnosed familial hypercholesterolemic homozygotes with
LDL-C >500 mg/dL
Group B Clinically diagnosed familial hypercholesterolemic heterozygotes with
LDL-C ≥300 mg/dL
Group C Clinically diagnosed familial hypercholesterolemic heterozygotes with
LDL-C ≥70 mg/dL and either documented coronary artery disease or
documented peripheral artery disease
Group D Clinically diagnosed familial hypercholesterolemic heterozygotes with
Lp(a) ≥60 mg/dL (or 130 nmol/L) and either documented coronary
artery disease or documented peripheral artery disease
Disclaimer: e device listed here serves only to illustrate examples of these types of FDA-
approved devices. is is not intended to be an endorsement of any commercial product,
process, service, or enterprise by the AHA or the ACC.
* As of January 2025: for updated indications for use, please review the website:
https://liposorber.com/posts/expanded-indication-for-kanekas-liposorber-la-15-system/
FDA indicates US Food and Drug Administration; LDL-C, low-density lipoprotein-
cholesterol; and Lp(a), lipoprotein(a).
