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J Am Coll Cardiol. 2019 Nov 19;74(20):2452-2462. doi: 10.1016/j.jacc.2019.08.010. Epub 2019 Aug 31.

Evolocumab for Early Reduction of LDL Cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS).

Author information

1
Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.
2
Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch.
3
Cardiocentro, Lugano, Switzerland.
4
Department of Cardiology, University Hospital Basel, Basel, Switzerland.
5
Department of Cardiology, Fribourg Hospital and University, Fribourg, Switzerland.
6
Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.
7
Service of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.
8
Department of Cardiology, Geneva University Hospital, Geneva, Switzerland.
9
CTU Bern, University of Bern, Bern, Switzerland.

Abstract

BACKGROUND:

Although 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:

The purpose of this study was to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab initiated during the in-hospital phase of ACS.

METHODS:

The authors 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 420 mg or matching placebo, administered in-hospital and after 4 weeks, on top of atorvastatin 40 mg. 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 to 0.79 mmol/l at week 8 in the evolocumab group, and from 3.42 to 2.06 mmol/l in the placebo group; the difference in mean percentage change from baseline was -40.7% (95% confidence interval: -45.2 to -36.2; p < 0.001). LDL-C levels <1.8 mmol/l were achieved at week 8 by 95.7% of patients in the evolocumab group versus 37.6% in the placebo group. Adverse events and centrally adjudicated cardiovascular events were similar in both groups.

CONCLUSIONS:

In this first randomized trial assessing a PCSK9 antibody in the very high-risk setting of ACS, evolocumab added to high-intensity statin therapy was well tolerated and resulted in substantial reduction in LDL-C levels, rendering >95% of patients within currently recommended target levels. (EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes [EVOPACS]; NCT03287609).

KEYWORDS:

LDL-C; PCSK9 inhibitor; acute coronary syndrome; evolocumab

PMID:
31479722
DOI:
10.1016/j.jacc.2019.08.010

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