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Real-world effectiveness and safety of evolocumab in very high-risk atherosclerotic cardiovascular disease patients with acute ischemic stroke

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Abstract

Background

We investigated evolocumab’s real-world effectiveness and safety on a background of statin therapy in the acute phase of ischemic stroke (IS) patients with a very high-risk of atherosclerotic cardiovascular disease (ASCVD).

Methods

A real-world, single-center, retrospective study was conducted in the neurology department at Tianjin Huanhu Hospital in China. Patients were divided into two groups: evolocumab treatment (140 mg every two weeks) or the standard of care (SOC) group. The primary efficacy outcome of the study was the achievement of a targeted lipid control rate and the incidence of major adverse cardiovascular events (MACE) by the end of the follow-up. MACE was defined as a composite of various cardiovascular events, cerebrovascular events such as stroke or TIA, and event-related deaths. Propensity score matching (PSM) analysis was utilized to account for confounding factors between groups. Survival analyses were performed using the Kaplan-Meier method and COX regression modeling.

Results

1080 AIS patients with very high-risk ASCVD were recruited. After PSM, there were 528 individuals, with 206 in the evolocumab group and 322 in the SOC group. At 12 months of follow-up, the proportion of LDL-C < 1.4mmol/L and ≥ 50% reduction was 44.91% in the evolocumab group, compared with only 3.12% of SOC-treated patients (p < 0.01). The median follow-up time for clinical events was 15 months. The evolocumab group was associated with a lower risk of cerebrovascular events compared to the SOC group (HR, 0.45; 95% CI, 0.23–0.89; p = 0.02).

Conclusions

This real-world study suggested that evolocumab on a background of statin reduced the LDL-C levels significantly and lowered the incidence of recurrent cerebrovascular events in the very high-risk ASCVD patients with AIS in China.

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Data availability

The dataset used and analyzed during the current study is available from the corresponding author on reasonable request.

Abbreviations

IS:

Ischemic Stroke

ASCVD:

Atherosclerotic Cardiovascular Disease

SOC:

Standard of Care

MACE:

Major Adverse Cardiovascular Events

PSM:

Propensity Score Matching

AIS:

Acute Ischemic Stroke

RCTs:

Randomized controlled trials

TIA:

Transient ischemic attacks

PCSK9:

Proprotein Convertase Subtilisinkexin type 9

ACS:

Acute Coronary Syndrome

MI:

Myocardial Infarction

LDL-C:

Low-Density Lipoprotein Cholesterol

TC:

Total cholesterol

TG:

Triglycerides

HDL-C:

High-density Lipoprotein Cholesterol

ApoA1:

Apolipoprotein A1

ApoB:

Apolipoprotein B

SAEs:

Serious Adverse Events

mRS:

Modified Rankin Scale

PAD:

Peripheral Artery Disease

DM:

Diabetes Mellitus

NIHSS:

National Institutes of Health Stroke Scale

HR:

Hazard Ratios

CHD:

Coronary Heart Disease

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Acknowledgements

We express our gratitude to Dr. Yan Xu of the Department of Interventional Therapy, Tianjin Medical University Cancer Institute and Hospital, whose invaluable assistance in statistical analysis has greatly enriched our research endeavors.

Funding

This work was supported by Tianjin Key Medical Discipline (Specialty) Construction Project (No. TJYXZDXK-052B) and Tianjin Health Commission Science and Technology Projects (TJWJ2021QN061).

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Authors and Affiliations

  1. Department of Neurology, Tianjin Key Laboratory of Cerebrovascular and Neurodegenerative Diseases, Clinical College of Neurology, Neurosurgery and Neurorehabilitation, Tianjin Huanhu Hospital, Tianjin Medical University, Tianjin, 300350, China

    Ting Zhang, Yajing Zhang, Yun Yang, Haibing Liao, Xun Li, Ran Liu, Xueqing Liu, Liqin Yang & Wei Yue

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Contributions

Conception and organization of the study: Ting Zhang, Yajing Zhang and Wei Yue.

Design and execution of the statistical analysis: Yajing Zhang and Ting Zhang.

Preparing the first draft: Ting Zhang.

Data collection and analysis, revision of the manuscript for intellectual content: Yun Yang, Haibing Liao, Xun Li, Ran Liu Xueqing Liu and Liqin Yang.

All authors have approved the final manuscript.

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Correspondence to Wei Yue.

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The Institutional Ethical Committee of the Tianjin Huanhu Hospital approved the study protocol with an exception to the requirement of written informed consent.

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Zhang, T., Zhang, Y., Yang, Y. et al. Real-world effectiveness and safety of evolocumab in very high-risk atherosclerotic cardiovascular disease patients with acute ischemic stroke. J Thromb Thrombolysis 57, 302–311 (2024). https://doi.org/10.1007/s11239-023-02925-4

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