Evolocumab Plus Statins Shows Significant Intracranial Plaque Regression Compared to Statins Alone: Study
China: A recent study published in the Journal of the American Heart Association has found that adding evolocumab-a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor—to standard statin therapy may significantly enhance intracranial atherosclerotic plaque regression compared with statin treatment alone.
The investigation, led by Xinzhi Hu and colleagues from the Department of Neurology at Peking Union Medical College Hospital, explored the impact of intensive lipid-lowering therapy on patients with intracranial atherosclerotic stenosis (ICAS).
Researchers analyzed data from a prospectively maintained high-resolution magnetic resonance imaging (MRI) database, focusing on individuals with ICAS of 50% or greater who had undergone two MRI evaluations over six months. The retrospective study included 179 statin-treated patients, divided into two groups: 50 patients who received additional evolocumab therapy and 129 patients who continued on statins alone.
The primary outcome was plaque response, defined as more than 5% regression in plaque size, while secondary outcomes included changes in plaque burden and stenosis degree. Statistical analyses using logistic and linear regression models assessed the association between evolocumab use and these imaging-based measures.
The study led to the following notable findings:
- Patients receiving evolocumab with statins showed a clear advantage over those on statins alone.
- Plaque regression was observed in 68% of the evolocumab group compared to 34.1% in the statin-only group.
- Median plaque burden reduction was greater with combination therapy (–8.2%) versus statins alone (–1.9%).
- Reduction in stenosis degree was also more pronounced in the evolocumab group (–15.3%) compared to statin monotherapy (–5.4%).
- After adjustment for confounders, evolocumab use remained significantly associated with improved outcomes, with an odds ratio for plaque regression of 6.67.
- Evolocumab users experienced a mean plaque burden reduction of 7.0% and a mean stenosis degree reduction of 20.3%.
- Subgroup analyses confirmed these benefits were consistent regardless of statin intensity.
The authors noted that adding a PCSK9 inhibitor to statin therapy could offer a more effective approach for reversing intracranial atherosclerotic plaque, which is a major risk factor for ischemic stroke. These results suggest that such combination therapy might hold promise for improving vascular health in high-risk patients.
However, the researchers cautioned that their conclusions are based on a retrospective design, which may be subject to selection bias and other limitations. They called for prospective randomized controlled trials to confirm these observations and determine whether the combination therapy leads to improved clinical outcomes.
Reference:
Hu X, Liu Y, Yuan W, Zhang Z, Li S, Cheng A, Yu Q, Guo H, Zou Y, Li M, Liu C, Xu Y, Xu W. Evolocumab Added to Statin Is Associated With Intracranial Atherosclerotic Plaque Regression Compared With Statin Alone. J Am Heart Assoc. 2025 Aug 19;14(16):e041251. doi: 10.1161/JAHA.124.041251. Epub 2025 Aug 18. PMID: 40820974.
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