Evolocumab initiated in-hospital for acute coronary syndromes significantly reduced LDL-C levels at 8 weeks compared to placebo (difference -40.7%; 95% CI -45.2 to -36.2; p<0.001).
RCT (n=308)
Double-blind
1:1
Does subcutaneous evolocumab 420 mg reduce LDL-C levels in patients hospitalized for acute coronary syndromes with elevated LDL-C?
Evolocumab initiated during the in-hospital phase of ACS on top of high-intensity statin therapy safely and significantly reduced LDL-C levels, allowing >95% of patients to achieve recommended targets at 8 weeks.
Effect estimate: Difference -40.7% (95% CI -45.2 to -36.2)
p-value: p=< 0.001
BACKGROUND While guidelines recommend in-hospital initiation of high-intensity statin therapy in patients with acute coronary syndromes (ACS), low-density lipoprotein cholesterol (LDL-C) target levels are frequently not attained. Evolocumab, a rapidly acting, potent LDL-C-lowering drug, has not been studied in the acute phase of ACS. OBJECTIVES To assess the feasibility, safety, and LDL-C lowering efficacy of evolocumab initiated during the in-hospital phase of ACS. METHODS We conducted an investigator-initiated, randomized, double-blind, placebo-controlled trial involving 308 patients hospitalized for ACS with elevated LDL-C levels (≥1.8 mmol/L on high-intensity statin for at least 4 weeks; ≥2.3 mmol/L on low- or moderate-intensity statin; or ≥3.2 mmol/L on no stable dose of statin). Patients were randomly assigned 1:1 to receive subcutaneous evolocumab 420mg or matching placebo, administered in-hospital and after 4 weeks, on top of atorvastatin 40mg. The primary endpoint was percentage change in calculated LDL-C from baseline to 8 weeks. RESULTS Most patients (78.2%) had not been on previous statin treatment. Mean LDL-C levels decreased from 3.61 mmol/L to 0.79 mmol/L at week 8 in the evolocumab group, and from 3.42 mmol/L to 2.06 mmol/L in the placebo group; the difference in mean percentage change from baseline was -40.7% (95% CI: -45.2 to -36.2; p95% of patients within currently recommended target levels.
“The study met its primary and secondary endpoints. What we learned from this study is that starting evolocumab very early, in hospital, in patients presenting with ACS appears to be safe and allows rapid achievement of recommended LDL targets in the vast majority — more than 90% of patients. This was achieved by only 10% of patients who were treated with statin alone, ie, with the current paradigm of lipid management in this setting.”
Koskinas et al. (2019) conducted an RCT in Acute Coronary Syndromes (n=308). Evolocumab vs. Placebo was evaluated on Percentage change in calculated LDL-C from baseline to 8 weeks (Difference -40.7%, 95% CI -45.2 to -36.2, p=< 0.001). Evolocumab initiated in-hospital for acute coronary syndromes significantly reduced LDL-C levels at 8 weeks compared to placebo (difference -40.7%; 95% CI -45.2 to -36.2; p<0.001).