June 29, 20231 citationsOpen Access

Real-World Effectiveness and Safety of Evolocumab in Very High-risk Atherosclerotic Cardiovascular Disease Patients with Acute Ischemic Stroke

Structured PICO

Does evolocumab added to standard of care improve lipid control and reduce major adverse cardiovascular events in patients with acute ischemic stroke and very high-risk ASCVD?

Population

1080 adults (aged 18-90 years) with acute ischemic stroke (AIS) of atherosclerotic origin within 14 days of onset and very high-risk ASCVD. Single-center in China. After propensity score matching, 528 patients were analyzed.

Intervention

Evolocumab 140 mg every two weeks combined with statins or standard of care (SOC) treatment.

Comparator

Standard of care (SOC) lipid-lowering treatment (atorvastatin, fluvastatin, rosuvastatin, or Xuezhikang Capsule).

Outcome

Achievement of targeted lipid control rate (LDL-C < 1.4 mmol/L and ≥50% reduction, and non-HDL-C < 2.2 mmol/L) at 12 months, and incidence of major adverse cardiovascular events (MACE: composite of ACS, MI, stable/unstable angina, revascularization, stroke/TIA, and event-related deaths) by the end of follow-up.composite

In a real-world Chinese cohort of AIS patients with very high-risk ASCVD, adding evolocumab to statin therapy significantly improved LDL-C target achievement and reduced recurrent cerebrovascular events, though it did not significantly reduce overall MACE.

Limitations

Retrospective design
Single-center study
Limitations of Kaplan-Meier cerebrovascular events analysis

Abstract

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. Propensity score matching (PSM) analysis was utilized to account for confounding factors between groups. Survival analysises were performed using the Kaplan-Meier method. 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 standard of care (SOC) group. At 12 months of follow-up, the proportion of LDL-C < 1.4mmol/L and ≥50% reduction was 44.9% in the evolocumab group, compared with only 3.1% of SOC-treated patients ( p = 0.000). 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 = 0.022) but did not significantly reduce the incidence of cardiovascular events (HR, 0.51; 95% CI, 0.17-1.51; p = 0.224), event-related deaths (HR, 0.71; 95% CI, 0.34-1.46; p = 0.349), or MACE (HR, 0.71; 95% CI, 0.44-1.06; p = 0.089). Conclusions This real-world study suggested that evolocumab on a background of statin reduced the LDL-C levels significantly with a well-tolerated profile and lowered the incidence of recurrent cerebrovascular events in the very high-risk ASCVD patients with AIS in China.

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