Coronary artery disease and familial hypercholesterolaemia patients' eligibility for PCSK-9 inhibitors: who is to benefit from lower ldl thresholds?

Abstract

Abstract Purpose High and very high cardiovascular risk patients are usually possible candidates for PCSK-9 inhibitors. Coronary artery disease (CAD) and Familial Hypercholesterolaemia (FH) patients belong to this group by definition, according to 2019 recent dyslipidaemia guidelines. The real contribution of each group to potential eligibility for PCSK-9 is to be investigated. Methods We enrolled 1892 inpatients prospectively for 12 months, diagnosed either with chronic CAD or with acute coronary syndrome (ACS). In order to test eligibility for PCSK-9 inhibitors, three different LDL thresholds were used in our model for very high and high risk groups: 55mg/dl and 70mg/dl, 70mg/dl and 100mg/dl, 100mg/dl and 130mg/dl, as recommended by the 2019 and 2016 ESC/EAS Guidelines for Dyslipidaemia and the National Health Care system, respectively. A proprietary software was developed and eligibility was determined by using patient clinical information and different criteria. Dutch Lipid Clinic Network criteria were used to determine heterozygous FH population. Results The eligible percentage for the three classifications was 18.6%, 7.7% and 1.8%, in the total CAD population respectively. Definite/ probable FH percentages among our population were 4.8%, 3.4%, 1.4%, respectively. Solely CAD eligible population was 13.8%, 4.3% and 0.4% respectively. The increase of the eligible percentages toward more recent guidelines was mostly attributed to the increasing number of coronary patients who become eligible as our criteria become stricter while the percentage of the eligible CAD/FH population only slightly increases. Conclusions FH is a significant cardiovascular risk factor but stricter criteria and LDL thresholds, favour solely CAD patients. Using real-world data and an adjustable model, we provide a realistic estimation of PCSK-9 eligibility among CAD patients. Funding Acknowledgement Type of funding sources: None. Subgroup analysis of eligible population