Multivessel Coronary Artery Disease, Acute Myocardial Infarction (AMI)
Conditions
Keywords
evelocumab, non-culprit vessel, multivessel coronary artery disease, acute myocardial infarction, outcome, target trial emulation
Brief summary
The goal of this Target Trial Emulation (TTE) study is to evaluate the effect of evolocumab on clinical prognosis in patients with multivessel disease (MVD) following acute myocardial infarction (AMI) who have deferred non-culprit vessel. The main question it aims to answer is: Does evolocumab lower risks of major adverse cardiovascular events (MACE) in patients with deferred non-culprit vessel after AMI?
Detailed description
This study aims to investigate the potential prognostic benefits of evolocumab in patients with MVD after AMI at 2-year follow-up. The primary endpoint is MACE, defined as a composite of cardiac death, myocardial infarction, stroke, angina-driven coronary revascularization, and rehospitalization for heart failure. This is a multicentre, cohort-based TTE study and the target RCT is the FOURIER trial.
Interventions
Evolocumab 140mg every two weeks
Any lipid lowering medication, including statin, ezetimibe, fibrates and etc.
Sponsors
Study design
Eligibility
Inclusion criteria
* Age ≥18 years old; * Acute myocardial infarction diagnosed at hospital admission; * Multivessel coronary artery disease diagnosed at primary invasive coronary angiography; * Culprit vessel successfully revascularized; * At lease 1 non-culprit vessel with ≥50% stenosis and deferred at the opinion of the operator, and no staged revascularization within 6 months.
Exclusion criteria
* Cardiac shock, hemodynamically unstable, or severe heart failure (Killip IV) * Any cardiac surgery within 6 weeks prior to screening; * Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m\^2 at screening; * Contraindication or allergy to iodinated contrast agent; * Malignancy except non-melanoma skin cancers, cervical, or breast ductal carcinoma in situ within the last 5 years; * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed in short term.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 2 years | A composite of cardiac death, myocardial infarction, and rehospitalization for heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 2 years | All-cause death |
| Myocardial infarction | 2 years | Myocardial infarction denotes the presence of acute myocardial injury detected by abnormal cardiac biomarkers in the setting of evidence of acute myocardial ischemia, according to the Fourth Universal Definition of Myocardial Infarction (2018). |
| Rehospitalization for heart failure | 2 years | Readmissions due to symptoms from clinically diagnosed heart failure with or without reduced left ventricular ejection fraction. |
Countries
China