Adjunctive PCSK9 Inhibitor Evolocumab Shows Promise in Preventing Early Neurological Deterioration in Acute Ischemic Stroke

Background

Early neurological deterioration (END) is a significant concern in acute ischemic stroke (AIS), associated with poor prognosis. Lowering low-density lipoprotein cholesterol (LDL-C) can improve atherosclerotic plaque stability and reduce post-stroke inflammation, potentially lowering END incidence.

Methods

This multicenter, prospective, open-label, blinded-endpoint clinical trial involved 272 AIS patients within 24 hours of onset. Participants were randomly assigned to receive either combination therapy of evolocumab and atorvastatin (PI group) or atorvastatin monotherapy (AT group). The primary outcome was END within 7 days, with secondary outcomes including LDL-C target achievement rate, changes in inflammatory factors, and stroke-related death within 7 days.

Results

The study found that 13.2% of patients in the PI group experienced END, compared to 24.3% in the AT group (RR -0.90; 95% CI: -1.59 to -0.22; p = 0.010). The LDL-C target achievement rate was significantly higher in the PI group (74.3%) than in the AT group (14.7%) (RR 3.27; 95% CI: 2.40–4.15; p = 0.001). Changes in IL-6 over 7 days were significantly lower in the PI group. By the 90th day, 83.1% of PI group patients had a modified Rankin Scale score ≤ 2, compared to 65.4% in the AT group (RR 0.51; 95% CI: 0.66–2.66; p = 0.001). No significant difference in stroke recurrence was observed between the groups within 90 days.

Conclusion

The combination therapy of evolocumab and atorvastatin within 24 hours of AIS onset may effectively reduce END incidence, lower LDL-C levels, and inhibit IL-6 elevation, potentially improving patient prognosis within 90 days.