A recent clinical trial has revealed that adding evolocumab to standard statin therapy significantly enhances plaque regression in patients with intracranial atherosclerotic stenosis (ICAS). Over a six-month period, patients receiving this combination therapy experienced a marked reduction in plaque burden compared to those treated with statins alone.
Research led by Xinzhi Hu, MD, from the Peking Union Medical College Hospital, aimed to address the limited studies focusing on the efficacy of evolocumab in ICAS. Previous investigations, notably the GLAGOV randomized clinical trial, have primarily concentrated on evolocumab’s effects in coronary atherosclerosis, highlighting its potential in managing cholesterol levels.
In this latest study, investigators utilized a high-resolution magnetic resonance imaging (HR-MRI) database established in 2015. They enrolled patients diagnosed with ICAS (50%-99% stenosis) from 2016 to 2023, ensuring comprehensive evaluations including medical history, conventional cranial MRI, HR-MRI, and blood tests. Participants were required to have atherosclerosis-confirmed intracranial stenosis and had to be on continuous lipid-lowering therapy, which could include statins and/or ezetimibe, with or without evolocumab.
The study included a total of 179 patients, all of whom were treated with statins. Among them, 50 patients were placed in the evolocumab add-on cohort, while 129 were included in the group receiving statins alone. The findings indicated a superior plaque response in the evolocumab cohort, with a notable 68% achieving a plaque regression greater than 5%, compared to 34.1% in the statin-only group.
Additionally, the analysis revealed that the add-on therapy group experienced a median plaque burden reduction of -8.2% compared to -1.9% in the statin-only cohort. Furthermore, the degree of stenosis was reduced by -15.3% in the evolocumab group, versus -5.4% in the other group.
Through adjusted regression analysis, the researchers determined significant associations between evolocumab use and improved outcomes. The odds ratio for plaque response was calculated at 6.67, indicating a robust correlation between the therapy and positive results. The reductions in plaque burden and stenosis degree were also statistically significant, with decreases of -7% and -20.3%, respectively.
These promising preliminary findings suggest that the combination of evolocumab and statins may provide a more effective strategy for reversing intracranial atherosclerotic plaque. However, Hu and colleagues emphasize the need for further prospective, randomized controlled studies to confirm these observations and explore their clinical implications in greater depth.
The study has been published in the Journal of the American Heart Association, highlighting the significance of evolving treatment options for patients suffering from ICAS. As cardiovascular diseases continue to be a leading global health concern, advancements in therapies like evolocumab could play a crucial role in improving patient outcomes in the future.