Effect of PCSK9 inhibitors on the quality of life in patients with acute coronary syndromes - exploratory analysis of the EMSIACS trial.

PROMIS effectively assesses patient health, but its use in evaluating the quality of life in acute coronary syndrome (ACS) patients on PCSK9 inhibitors (PCSK9i) remains unexplored. This study examined the impact of PCSK9i on quality of life in ACS patients, comparing PCSK9i plus statin versus statin-only therapy using PROMIS-10, and analyzed the association between PROMIS scores and major adverse cardiovascular events (MACE). The EMSIACS trial is a prospective, randomized, open-label, parallel-group, multicenter study registered at ClinicalTrials.gov (NCT04100434). This paper presents the exploratory outcomes of this trial. From September 2020 to March 2022, a total of 500 ACS patients were enrolled. Patients were randomly assigned in a 1:1 ratio to receive Evolocumab plus statin therapy or statin-only therapy. The quality of life was assessed using PROMIS 10 at baseline, week 12, and week 48. PROMIS 10 includes two summary scores: Global Physical Health (GPH, including physical health, physical function, fatigue and pain intensity) and Global Mental Health (GMH, including overall quality of life, mental health, satisfaction with social activities, and emotional problems). At week 48, MACE were evaluated in two groups. At week 12, Evolocumab significantly improved Global Physical Health (GPH) (P < 0.001) and Global Mental Health (GMH) scores (P < 0.001), particularly in pain intensity, mental health, and social activity satisfaction (P < 0.001). By week 48, both groups improved significantly from baseline, with no significant differences between them(GPH: P = 0.120; GMH: P = 0.105). Emotional problems worsened in patients with MACE (P = 0.015). Exploratory analysis suggested that PCSK9i significantly improved short-term quality of life in ACS patients outperforming statins especially in pain intensity, mental health, and social activity satisfaction. In the long term, PCSK9i sustained quality of life improvements. The occurrence of MACE in ACS patients may associate with emotional problems.Clinical trial registration number: NCT04100434.