Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients

Study Overview
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Brief Summary
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In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI), previous studies have indicated that routine invasive treatment confers more benefit as compared to selective invasive approach. The benefits of routine invasive coronary intervention have been the most evident in patients with higher baseline risk profile. However, the question of optimal timing of routine invasive intervention remains unsolved. Immediate invasive intervention early after admission for non-STEMI may limit myocardial necrosis by securing the patency of the culprit coronary artery. Nevertheless, several previous studies reported higher levels of biomarkers of myocardial injury in patients undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients may thus amount to whether the risk of intervening on an unstable plaque is greater than the risk of new ischemic events while waiting for the invasive procedure. The purpose of the present study is to compare effects of immediate coronary intervention, within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission, in patients witn non-STEMI.

Official Title
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Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Immediate invasive intervention
* Procedure: Delayed invasive intervention
* Device: Coronary artery stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: episode of chest pain occurring no longer than 24 hours prior to admission elevation of cardiac troponin I above the upper limit of normal (ULN) new ST-segment depression at least 1 millivolt (mV) and/or T-wave inversion or transient ST-segment elevation in ≥ 2 contiguous leads Exclusion Criteria: age < 18 years persistent ST-segment elevation hemodynamic instability cardiogenic shock on admission life-threatening ventricular arrhythmias on admission refractory angina on admission active bleeding any contraindication for the use of dual antiplatelet therapy (DAPT) presence of comorbidities with life expectancy < 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate invasive intervention<br>Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission | Procedure: Immediate invasive intervention<br>* Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission<br>Device: Coronary artery stenting<br>* Implantation of coronary stents<br>|
| Active Comparator: Delayed invasive intervention<br>Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and within 2-72 hours of admission | Procedure: Delayed invasive intervention<br>* Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and/or within 2-72 hours of admission<br>Device: Coronary artery stenting<br>* Implantation of coronary stents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all-cause death or myocardial reinfarction |  | within 30 days of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all-cause death, myocardial reinfarction or recurrent ischemia |  | within 30 days of randomization | 
| All-cause mortality |  | within 30 days, 1, 3 and 5 years after randomization | 
| Myocardial reinfarction |  | within 30 days, 1, 3 and 5 years after randomization | 
| Stroke |  | within 30 days, 1, 3 and 5 years after randomization | 
| Recurrent ischemia |  | within 30 days of randomization | 
| Major bleeding |  | within 30 days, 1, 3 and 5 years after randomization | 
| Duration of index hospitalization |  | at 30-day follow-up, the duration of hospital stay is assessed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-STEMI, immediate, delayed, PCI