Abstract 4358653: Effects of Bempedoic Acid on Venous Thromboembolism: a Post-Hoc Analysis of The CLEAR Outcomes Trial

Abstract

Background: Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), is a frequent condition that can lead to significant morbidity and mortality. Statins, monoclonal antibody PCSK9 inhibitors and their combination are associated with a reduced risk of VTE. The effect of bempedoic acid on VTE risk is unknown. Research Question: Is bempedoic acid associated with a reduced risk of VTE? Methods: CLEAR Outcomes was a randomized, double-blind, placebo-controlled, cardiovascular (CV) outcomes trial that compared bempedoic acid with placebo in a statin-intolerant population at high risk for, or with established CV disease. We assessed VTE outcomes (composite of DVT or PE), DVT, and PE. Outcomes were analyzed in a time-to-first-event manner using cox-proportional hazards models. Results: A total of 13970 participants were randomized, 6992 to bempedoic acid, and 6978 to placebo. At the time of randomization, 275 subjects (2%) had a prior history of VTE, and 1219 (8.7%) were taking systemic anticoagulation. Over a median follow-up of 40.6 months, 106 VTE events occurred. Compared with placebo, bempedoic acid reduced the risk of VTE (HR 0.58; 95% CI 0.39-0.86; Figure). Findings were consistent for individual components of VTE, namely DVT (HR 0.56; 95% CI 0.31-1.00; Figure), and PE (HR 0.61; 95% CI 0.37-1.00; Figure). Conclusions: Treatment with bempedoic acid in patients with statin intolerance and at high risk for, or with established CV disease was associated with a reduction in VTE events. These data highlight the role of lipid-lowering therapies in VTE prevention.