Determinants of lipid lowering therapy intensification in very high risk patients with dyslipidaemia eligible for PCSK9 monoclonal antibodies: 1-year outcomes of the PERI-DYS study.

PURPOSE: The PERI-DYS study evaluates patients at very high cardiovascular (CV) risk, including those who receive PCSK9 monoclonal antibodies (PCSK9-mAb) and those who are eligible for PCSK9-mAb but do not receive them.

METHODS: This is a prospective observational registry at 70 sites in Germany, categorising patients by PCSK9-mAb treatment status at baseline. LDL cholesterol (LDL-C) changes and factors influencing lipid-lowering therapy (LLT) intensification were assessed after one year. Identifier: ClinicalTrials.gov NCT03110432.

RESULTS: Among 1565 patients, LDL-C levels decreased from 91.0 mg/dL at baseline to 73.5 mg/dL at 6 months and 71.5 mg/dL at 12 months. A total of 33.1% achieved the LDL-C goal (<55 mg/dL) according to EAS/ESC dyslipidaemia guidelines, with achievement rates ranging from 16.3% in those without PCSK9-mAb and statins to 50.5% in those on combined PCSK9-mAb, statins, and/or ezetimibe. Lipid intensity changed in 22.3% of patients, with 14.8% experiencing intensification and 9.3% reduction. Significant predictors of LLT intensification included younger age (odds ratio (OR) for 60+ years 0.73), no baseline ezetimibe (OR 0.43), LDL-C > 100 mg/dL (OR 3.90), and statin intolerance (OR 0.68).

CONCLUSIONS: Despite eligibility for PCSK9-mAb treatment and management by specialised physicians, most patients did not reach the LDL-C target, and LLT intensification was rare. This suggests an underutilisation of available treatments, highlighting a gap in the management of high CV risk patients.