AHA Scientific Sessions 2026 Abstract · Nov 2, 2026
Cardiovascular Outcomes of Inclisiran in Patients with Elevated Cardiovascular Risk and Metabolic Dysfunction Associated Steatotic Liver Disease
By Ong TE, Koo TH, Tan DHC et al.
Background: Metabolic dysfunction associated steatotic liver disease (MASLD) is linked to increased cardiometabolic risk. Although ongoing trials suggest the potential benefit of inclisiran in high-risk cardiovascular populations, data in patients with concomitant MASLD remain limited. Hypothesis: Inclisiran is associated with improved cardiovascular outcomes in patients with elevated cardiovascular risk receiving lipid-lowering therapy and MASLD. Methods: Using the TriNetX Global Collaborative Network, we identified adults aged ≥18 years with MASLD and elevated cardiovascular risk, defined as hyperlipidemia, hypertension, diabetes mellitus, smoking, chronic kidney disease, or obesity, who were receiving statin and ezetimibe therapy from January 1, 2023, to January 1, 2026. Patients were stratified into inclisiran and no inclisiran groups. Propensity score matching was performed using baseline demographics, cardiovascular comorbidities, and concomitant medications. Primary outcomes included all-cause mortality, all-cause hospitalization, acute myocardial infarction, acute heart failure, and cerebrovascular accident. Safety outcomes included acute liver injury and acute kidney injury. A secondary analysis compared inclisiran with PCSK9 monoclonal antibodies, including alirocumab or evolocumab. Hazard ratios with 95% confidence intervals were reported. Results: After propensity score matching, 317 patients were included in each cohort. Inclisiran use was associated with lower three-year hazards of all-cause hospitalization compared with no inclisiran (25.6% vs 44.8%; HR, 0.58; 95% CI, 0.44 - 0.76; p<0.01) and acute kidney injury (10.4% vs 19.2%; HR, 0.62; 95% CI, 0.41 - 0.95; p=0.03). Inclisiran use was not significantly associated with acute myocardial infarction (8.2% vs 7.6%; HR, 1.33; 95% CI, 0.76 - 2.33; p=0.32), acute heart failure (5.7% vs 11.0%; HR, 0.58; 95% CI, 0.32 - 1.02; p=0.06), or cerebrovascular accident (7.3% vs 7.6%; HR, 1.12; 95% CI, 0.63 - 2.00; p=0.69). No all-cause mortality or acute liver injury events were observed in either group. In the secondary analysis, inclisiran use was not significantly associated with all-cause hospitalization, acute myocardial infarction, acute heart failure, cerebrovascular accident, or acute kidney injury compared with PCSK9 monoclonal antibodies. Conclusions: Among patients with elevated cardiovascular risk and MASLD receiving statin and ezetimibe therapy, inclisiran use was associated with lower three-year all-cause hospitalization compared with no inclisiran. In addition, inclisiran demonstrated comparable cardiovascular outcomes to PCSK9 monoclonal antibodies. These findings support further prospective evaluation of inclisiran in patients with concomitant MASLD and persistent cardiovascular risk.