Abstract / Summary
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group at day 28; last-observation-carried-forward (LOCF) was applied to impute missing 12-week endpoints for the withdrawn participant.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).