European Society of Cardiology/European Atherosclerosis Society Task Force consensus statement on proprotein convertase subtilisin/kexin type 9 inhibitors: Practical guidance for use in patients at very high cardiovascular risk

This ESC/EAS Task Force consensus document provides clinicians with practical guidance for the use of PCSK9 inhibitor treatment in patients at very high risk of (recurrent) cardiovascular events with poorly controlled LDL-C levels (see Box 3). This Joint Task Force recommends that treatment with a PCSK9monoclonal antibody may be considered in very high risk patients with ASCVD (clinical or unequivocal on imaging4,5), including those with progressive ASCVD, or diabetes mellitus (with target organ damage or a major cardiovascular risk factor); or in patients with severe FH without ASCVD with substantially elevated LDL-C levels despite maximal statin/ezetimibe therapy. Patients in these groups with verified statin intolerance (SAMS) may be also considered for PCSK9 inhibition. These recommendations identify a patient population who are likely to derive most potential benefit from this novel therapy, while also taking account of the financial restraints within healthcare budgets. This document is based on current evidence for PCSK9 monoclonal antibody therapy, and will be re-evaluated with the availability of data from large, randomized cardiovascular outcomes studies evaluating the impact of these novel agents on ASCVD and related thromboembolic events.