Effect of Evolocumab Added to Moderate-Intensity Statin Therapy on LDL-C Lowering and Cardiovascular Adverse Events in Patients With Acute Coronary Syndrome

Background: Several studies have demonstrated that using a higher dose of statin can easily induce liver injury and myopathy. Low-density lipoprotein cholesterol (LDL-C) is a well-established modifiable risk factor for cardiovascular disease; however, the large majority of Chinese patients cannot meet the target level of LDL-C recommended by the Chinese expert consensus. Evolocumab has been demonstrated to reduce LDL-C by approximately 60% in many studies. Nevertheless, whether combined evolocumab and moderate-intensity statin is as effective in lowering LDL-C and decreasing incidence of MACE in Chinese patients presenting with the acute phase of acute coronary syndrome (ACS) remains unknown. Therefore, the “Evolocumab added to Moderate-Intensity Statin therapy on LDL-C lowering and cardiovascular adverse events in patients with Acute Coronary Syndrome” (EMSIACS) is conducted.Methods: The EMSIACS is a prospective, randomized, open-label, parallel-group, multicenter study involving analyzing the feasibility and efficacy of evolocumab added to moderate-intensity statin therapy on lowering LDL-C levels in adult Chinese patients hospitalized for acute phase ACS. The sample size calculation is based on the primary outcome, and 500 patients will be planned to recruit. Patients are randomized in evolocumab arm (evolocumab 140mg every 2weeks plus rosuvastatin 10mg/day or atorvastatin 20mg/day) and statin-only arm (rosuvastatin 10mg/day or atorvastatin 20mg/day). The primary outcome is the percentage change in LDL-C in weeks 4 and week 12 after treatment. The secondary outcome is the occurrence of MACE after 12weeks and 1year of treatment.Discussion: If the EMSIACS trial endpoints prove statistically significant, the evolocumab added to moderate-intensity statin therapy will have the potential to effectively lower subjects’ LDL-C levels, especially for the Chinese patients with acute phase ACS. However, if the risk of MACE is not significantly different between the two groups, we may extend follow-up time for secondary outcome when the clinical trial is over.Clinical trial registration: The study is registered to ClinicalTrials.gov (NCT04100434), which retrospectively registered on November 24, 2020.

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3725 Chronic statin therapy prior to hospitalization for an acute coronary syndrome is associated with reduced inhospital mortality. An experience from the Euro-Heart acute coronary syndrome survey

European Heart Journal ◽

10.1016/s0195-668x(03)96277-4 ◽

2003 ◽

Vol 24 (5) ◽

pp. 724 ◽

Cited By ~ 1

Author(s):

T LENDERINK

Keyword(s):

Acute Coronary Syndrome ◽

Statin Therapy ◽

Inhospital Mortality ◽

Coronary Syndrome

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Faculty Opinions recommendation of Prevention of Stroke with the Addition of Ezetimibe to Statin Therapy in Patients With Acute Coronary Syndrome in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial).

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.731685021.793541373 ◽

2018 ◽

Author(s):

Wilbert Aronow

Keyword(s):

Acute Coronary Syndrome ◽

Statin Therapy ◽

International Trial ◽

Coronary Syndrome

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Early, Intensive and Long-term Statin Therapy in Acute Coronary Syndrome: Focus on Anti-inflammatory Mechanisms

Vascular Disease Prevention ◽

10.2174/1567270054368943 ◽

2005 ◽

Vol 2 (3) ◽

pp. 181-186 ◽

Cited By ~ 3

Author(s):

Jian-Jun Li ◽

Sheng-Shou Hu

Keyword(s):

Acute Coronary Syndrome ◽

Statin Therapy ◽

Coronary Syndrome ◽

Anti Inflammatory

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Long-Term Efficacy Of Lower Intensity Statin Therapy In Chinese Acute Coronary Syndrome Patients

Value in Health ◽

10.1016/j.jval.2018.07.199 ◽

2018 ◽

Vol 21 ◽

pp. S26

Author(s):

BP Yan ◽

CK Chan ◽

MC Wong ◽

OT To ◽

VW Lee

Keyword(s):

Acute Coronary Syndrome ◽

Statin Therapy ◽

Lower Intensity ◽

Coronary Syndrome ◽

Term Efficacy

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High Dose Statins: Is it Beneficial over Conventional Dose of Statin in Acute Coronary Syndrome?

Cardiovascular Journal ◽

10.3329/cardio.v2i2.6648 ◽

1970 ◽

Vol 2 (2) ◽

pp. 245-251

Author(s):

AEM M Islam ◽

AAS Mazumder

Keyword(s):

Acute Coronary Syndrome ◽

Heart Disease ◽

Statin Therapy ◽

Disease Risk ◽

Cardiovascular Disease Risk ◽

Surgical Care ◽

High Dose ◽

Coronary Syndrome ◽

Conventional Dose ◽

Coronary Events

Increasing burden of cardiovascular disease risk factors has led to increase in the incidence in the coronary artery disease (CAD). Advancements in medical and surgical care of patients with heart disease have led to a large number of people surviving acute coronary events. Patients with acute coronary syndrome (ACS) are at high risk for recurrent coronary events, sudden death, and all cause mortality. Conventional revascularization therapies reduce the risk of further ischaemia but do not affect the underlying atherosclerotic disease. Statins have a proven record in the secondary prevention of coronary heart disease. Furthermore, statins have been shown to exert various pleotropic effects, which may stabilize vulnerable atherosclerotic plaques. Therefore, initiating, statin therapy in patients with established CAD is both beneficial and more cost effective. Trials conducted in recent times have addressed the issue of whether higher dose statin therapy provides further reductions in the risks of cardiovascular events following an acute coronary syndrome diagnosis, over and above that provided by a conventional dose statin regimen. However, recent trials of high dose statin therapy in patients with acute coronary syndromes have yielded conflicting results. The aim of this article is to provide a critical and up-to-date summary of the findings of clinical trials of intensive statin therapy, including a brief overview of safety and efficacy of such treatments. Keywords: Statin; Acute coronary syndrome. DOI: 10.3329/cardio.v2i2.6648Cardiovasc. j. 2010; 2(2) : 245-251

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The Threshold of Admission Glycemia as a Predictor of Adverse Events in Diabetic and Non-Diabetic Patients with Acute Coronary Syndrome

Clinical medicine Cardiology ◽

10.4137/cmc.s2289 ◽

2009 ◽

Vol 3 ◽

pp. CMC.S2289 ◽

Cited By ~ 3

Author(s):

Taysir S. Garadah ◽

Salah Kassab ◽

Qasim M. Al-Shboul ◽

Abdulhai Alawadi

Keyword(s):

Acute Coronary Syndrome ◽

Adverse Events ◽

Diabetic Patients ◽

Stress Hyperglycemia ◽

Coronary Syndrome ◽

History Of ◽

Group 3 ◽

Group 2 ◽

High Level ◽

Group 1

Recent studies indicated a high prevalence of hyperglycemia in non-diabetic patients presenting with acute coronary syndrome (ACS). However, the threshold of admission glucose (AG) as a predictor of adverse events in ACS is unclear. Objective The aim of this study was to assess the threshold of admission glucose (AG) as a predictor of adverse events including Major Acute Cardiac Events (MACE) and mortality, during the first week of admitting patients presenting with ACS. Material and Methods The data of 551 patients with ACS were extracted and evaluated. Patients were stratified according to their blood glucose on admission into three groups: group 1: <7 mmol/L (n = 200, 36.3%) and group 2: >7 mmol/L and <15 mmol/L (n = 178, 32.3%) and group 3: ≥15 mmol/L (n = 173, 31.4%). Stress hyperglycemia was arbitrarily defined as AG levels > 7 mmol/L (group 2 and 3). Patients with ACS were sub-divided into two groups: patients with unstable angina (UA, n = 285) and those with ST segment elevation myocardial Infarction (STEMI, n = 266) and data were analyzed separately using multiple regression analysis. Results The mean age of patients was 59.7 ± 14.8 years and 63% were males. The overall mortality in the population was 8.5% (5.4% in STEMI and 3.1% in UA) patients. In STEMI patients, the odds ratio of stress hyperglycemia as predictor of mortality in group 3 compared with group 1 was 3.3 (CI 0.99-10.98, P < 0.05), while in group 2 compared with group 1 was 2.4 (CI: 0.75-8.07, P = 0.065) after adjustment for age and sex. Similarly, in UA patients, the odds ratio of stress hyperglycemia in group 3 compared with group 1 was 2.7 (CI 0.37-18.98, P < 0.05), while in group 2 compared with group 1 was 2.4 (CI: 0.4-15.2, P = 0.344) after adjustment for age and sex. The incidence of more than 2 MACE in both STEMI and UA patients was higher in group 3 compared with the other two groups. Regression analysis showed that history of DM, high level of LDL cholesterol, high level of HbA1c, and anterior infarction were significant predictors of adverse events while other risk factors such as BMI, history of hypertension and smoking were of no significance. Conclusion This study indicates that the stress hyperglycemia on admission is a powerful predictor of increased major adverse events and hospital mortality in patients with acute coronary syndrome.

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