Revascularization StrategIes for ST Elevation Myocardial Infarction Trial

Study Overview
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Brief Summary
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This study is being conducted in patients with a major heart attack caused by a blocked artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50% of people with an heart attack are found to have one or more additional narrowings that did not cause the heart attack. At present the best way to manage these additional blockages is not known. Many cardiologist recommend opening these blockages at at a later time after the heart attack. The present study is examining if PCI of all blockages at the same time as the PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI). Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and monitor adverse events.

Official Title
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Revascularization StrategIes for ST Elevation Myocardial Infarction Trial

Conditions
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Primary Angioplasty, ST Elevation Myocardial Infarction, Coronary Stenting

Intervention / Treatment
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* Procedure: Same sitting PCI with complete revascularization
* Procedure: Staged PCI with complete revsacularization >48 hours pf primary PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ST elevation myocardial infarction evidenced by new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2mV) in men or ≥ 1.5mm (0.15mV) in women in leads V2-V3 and/or ≥ 1mm (0.1mV) in other contiguous chest leads or limb leads. MVD as evidenced by > one significant (>70% by visual assessment or FFR < 0.80 for 50-70% stenosis) stenosis in the non-IRA >2mm in diameter. Successful IRA-PCI with <30% residual angiographic stenosis and TIMI III flow Written informed consent Exclusion Criteria: Age ≤ 18 years Prior coronary artery bypass graft (CABG) surgery Administration of thrombolytic therapy. Hemodynamic instability as evidenced by SBP<90 mmHg, Killip class ≥3, and/or need for inotropes/vasopressors. Known renal insufficiency (estimated GFR < 30 ml/min/1.73m2) Non-IRA stenosis is a chronic total occlusion (CTO) Plan by treating physician to treat non-IRA stenosis with coronary artery bypass surgery

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Same sitting complete revascularization<br>After treatment of the IRA, subjects will undergo PCI of all suitable significant non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm). | Procedure: Same sitting PCI with complete revascularization<br>* revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting at the time of primary PCI<br>|
| Active Comparator: Staged non-IRA PCI<br>Only the IRA will be intervened upon during the index primary PCI procedure. Staging of the non-IRA lesions will be performed 48 hours to 45 days after the primary PCI procedure. All suitable non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm) will be treated with PCI irrespective of whether there are clinical symptoms or evidence of ischemia. | Procedure: Staged PCI with complete revsacularization >48 hours pf primary PCI<br>* revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting >48 hours to 45 days post primary PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse clinical events | Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding |  | 90 days | 
| Stroke |  | 90 days | 
| Contrast nephropathy |  | 90 days | 
| Major vascular complication |  | 90 days | 
| EQ-5D quality of life assessment |  | 90 days | 
| Incremental Cost-Effectiveness Ratio (ICER) |  | 90 days | 
| Myocardial infarction |  | 90 days | 
| Heart failure |  | 90 days | 
| All cause mortality |  | 90 days | 
| Unplanned revascularization |  | 90 days |