Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI

Study Overview
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Brief Summary
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The study will compare clinical outcomes between complete revascularization during hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial infarction.

Detailed Description
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This study is prospective, randomized, multicentre, open label study in patients with ST elevation myocardial infarction (STEMI) with multivessel coronary artery disease (MVD) defined as >70% stenosis in a non-culprit vessel, initially treated with culprit only primary PCI. The patients will be enrolled in four high volume PCI centers after successful culprit only primary PCI and then randomly assigned to one of three treatment arms:1. complete revascularization of all non-culprit significant lesions in a single session during initial hospitalization; 2. same revascularization in a single session after 30 days; 3.revascularization or it's deferral based on ischemia testing using Dobutamin stress echocardiography. The study will explore differences in occurrence of major adverse cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization) and complications of interventions during 12 months follow-up.

Official Title
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Appropriate Timing of Complete Revascularization for Multivessel Coronary Artery Disease After Culprit Only Primary Percutaneous Coronary Intervention (PCI) for ST Elevation Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: PCI
* Procedure: dobutamine stress echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and electrocardiographic signs of first ever ST elevation myocardial infarction (chest pain lasting less than 12 hours with persistent ST elevation of ≥ 1mm in two contiguous leads on ECG recording) Multivessel coronary artery disease (MVD) on initial coronary angiogram, defined as visually assessed stenosis of more than 70% of any of the non-culprit vessels Treated with primary PCI of infarct related artery (IRA) only. Exclusion Criteria: Hemodynamically unstable patients defined as presence of cardiogenic shock, intraaortic balloon pump (IABP) implantation and mechanical ventilation prior, during and after primary PCI; Presence of significant valvular disease; Decision that patient needs to be treated with coronary artery bypass graft (CABG) and/or valvular replacement or reconstruction surgery after initial culprit only PCI; Myocardial infarction is caused by stent thrombosis: Chronic total occlusion of any of the coronary arteries on initial angiogram; Previously treated by CABG surgery; Estimated life expectancy less than one year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: complete PCI at initial hospitalization<br>Staged, complete revascularization of all non-culprit significant lesions in a single PCI session during initial hospitalization for ST elevation myocardial infarction | Procedure: PCI<br>* percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis<br>* Other names: percutaneous coronary intervention;|
| Experimental: complete PCI after 30 days<br>Staged, complete revascularization of all non-culprit significant lesions in a single PCI session after 30 days from initial hospitalization for ST elevation myocardial infarction | Procedure: PCI<br>* percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis<br>* Other names: percutaneous coronary intervention;|
| Active Comparator: Dobutamine stress testing<br>Revascularization by PCI or deferral of revascularization of non-culprit coronary artery lesions based on ischemia testing using Dobutamin stress echocardiography | Procedure: PCI<br>* percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis<br>* Other names: percutaneous coronary intervention;Procedure: dobutamine stress echocardiography<br>* Echocardiographic stress test of provoked myocardial ischemia using dobutamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardio-cerebral events | cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac death | Occurence of death caused by cardiac condition | one year | 
| repeated myocardial infarction | Occurrence of repeated myocardial infarction in the study groups | one year | 
| complications of percutaneous coronary intervention | Occurrence of vascular complications of PCI, contrast induced nephropathy (CIN) and bleeding events | one year | 
| stent thrombosis | Occurrence of stent thrombosis based on Associated Research Consortium (ARC) criteria | two years | 
| hospitalization for heart failure | Occurrence of hospitalization for heart failure in the study groups | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, percutaneous coronary intervention, multivessel coronary artery disease, dobutamine stress echocardiography