Effects of evolocumab on lipid profile and circulating endothelial biomarkers in patients undergoing primary...

ObjectiveTo evaluate the effects of early evolocumab plus atorvastatin on lipid metabolism, circulating endothelial biomarkers, and inflammation in STEMI patients undergoing primary percutaneous coronary intervention (PPCI).MethodsIn this single-center, open-label trial, 90 patients were randomized 1:1 to atorvastatin 20 mg/day (control, n=45) or atorvastatin 20 mg/day plus evolocumab 140 mg biweekly (combination, n=45) for 12 weeks. One patient withdrew from the combination group at day 28; last-observation-carried-forward (LOCF) was applied to impute missing 12-week endpoints for the withdrawn participant. All 90 randomized patients were included in the intention-to-treat (ITT) analytic population. Lipid profiles, endothelial biomarkers, inflammatory cytokines, and safety outcomes were assessed at baseline and 12 weeks. Standard Analysis of Covariance (ANCOVA) with 12-week value as dependent variable and corresponding baseline level as covariate was used to compare between-group treatment effects for normally distributed outcomes; non-parametric tests were applied for non-normally distributed data. All secondary biomarker, cardiac function and safety analyses were predefined as exploratory without multiplicity adjustment.ResultsBaseline characteristics were well-balanced. The primary endpoint-change in LDL-C from baseline-was significantly greater in the combination group (adjusted mean difference: -0.31 mmol/L, 95% CI: -0.60 to -0.02, P=0.037). A significantly higher proportion achieved the guideline-recommended LDL-C target of <1.4 mmol/L (48.89% vs. 22.2%, P=0.007). Secondary endpoints showed favorable changes in nitric oxide, endothelin-1, and sICAM-1 (all P<0.05), and a significant reduction in IL-6 by non-parametric testing (P=0.005). No significant between-group differences were observed for other biomarkers, cardiac function indices, or adverse events (all P>0.05).ConclusionsIn this small, single-center trial, early evolocumab added to moderate-intensity atorvastatin was associated with additional LDL-C reduction and favorable changes in selected circulating endothelial biomarkers and IL-6 over 12 weeks in STEMI patients post-PPCI, no major safety signal was observed in this short-term study. These findings are preliminary and require confirmation in larger, adequately powered trials using guideline-directed high-intensity statin therapy as the standard of care. Chinese Clinical Trial Register submission ID: PID343553 (application currently under administrative review, not publicly released).