Initiating evolocumab during the acute phase of ACS, on top of high-intensity statin therapy, significantly reduced LDL-C in patients presenting to hospital with acute coronary syndrome (ACS), with more patients achieving target LDL-C levels by week eight. The findings come from the investigator-led EVOPACS trial presented Aug. 31 in a Late-Breaking Science session at ESC Congress 2019 and simultaneously published in the Journal of the American College of Cardiology.

The first randomized, double-blind trial to assess a PCSK9 inhibitor in a very high-risk setting of ACS, according to the authors, examined the feasibility, safety and LDL-C lowering efficacy of this approach. The authors note that high-intensity statin therapy initiated in-hospital for ACS patients reduces early events, but onset of action is delayed and many patients do not achieve LDL-C targets with only this therapy.

Patients hospitalized for ACS (n=308) with elevated LDL-C levels were randomly assigned to receive evolocumab 420 mg (n=155) or placebo (n=153) initiated in hospital and then every four weeks. All patients received atorvastatin 40 mg. Most patients (78.2 percent) had not been on statin treatment previously.

Calculated LDL-C was available at baseline and at eight weeks in 277 patients (90 percent). At week eight, the mean LDL-C levels decreased from 3.61 mmol/L (139.59 mg/dL) to 0.79 mmol/L (30.5 mg/dL) with evolocumab and from 3.42 mmol/L (132.25 mg/dL) to 2.06 mmol/L (79.66 mg/dL) with placebo.

At eight weeks, the primary endpoint of the percentage change in LDL-C from baseline was –77.1±15.8 percent in the evolocumab group vs. –35.4±26.6 percent in the placebo group, for a least-squares mean difference of –40.7 percent (p<0.001). The LDL-C reductions were observed at four weeks and maintained at eight weeks.

More patients in the evolocumab group than in the placebo group (95.7 percent vs. 37.6 percent) achieved an LDL-C reduction to <1.8 mmol/L (69.60 mg/dL).

Evolocumab was well tolerated and adverse events (the secondary endpoint) did not differ significantly between the groups. Two deaths unrelated to study drug occurred.

"Treatment with evolocumab allowed rapid attainment of currently recommended LDL-C target levels by >95 percent of patients compared with one-third of placebo-treated patients," the authors concluded.

Clinical Topics: Acute Coronary Syndromes, Diabetes and Cardiometabolic Disease, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Prevention, Lipid Metabolism, Nonstatins, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: ESC 19, ESC Congress, Cholesterol, Cholesterol, LDL, Acute Coronary Syndrome, Primary Prevention, Dyslipidemias, Angiography, Percutaneous Coronary Intervention

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