Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.

Study Overview
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Brief Summary
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The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.

Detailed Description
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Introduction: Primary percutaneous coronary intervention (PPCI) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with ST segment elevation (STEMI). It is not clear, what is the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by primary percutaneous coronary intervention (PPCI) who have at least one significant stenosis of non-culprit coronary artery. Numerous cardiology centers perform staged PCI on significant stenoses involving the non-infarct coronary artery (arteries) 3-40 days after PPCI, but the benefit of this staged PCI for such patients has not yet been clearly demonstrated. Aim of study: The aim is to find the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by PPCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively. Hypothesis: Our hypothesis is that complete staged revascularization of significant stenoses of the coronary arteries will improve the long-term prognosis in patients after PPCI as compared to conservative management.

Official Title
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Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial

Conditions
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Coronary Artery Stenosis

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with acute myocardial infarction with ST segment elevation (STEMI) Angiographically successful primary PCI of infarct-related stenosis (TIMI flow grades II-III) One or more other stenoses (≥70%) of non-infarct coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm) Enrollment ≥48 hours following onset of symptoms Exclusion Criteria: Stenosis of the left main of left coronary artery ≥ 50% Hemodynamically significant valvular disease Patients in cardiogenic shock during STEMI Hemodynamic instability Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI

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 |
| --- | --- |
| Active Comparator: Complete revascularization<br>Percutaneous coronary intervention of non-infarct coronary arteries | Procedure: Percutaneous coronary intervention<br>* PCI of significant stenoses of non-infarct coronary arteries<br>|
| No Intervention: Conservative management<br>standard guideline-based medical therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite endpoint of death, nonfatal acute myocardial infarction and stroke |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular death |  | 2 years | 
| recurrent myocardial infarction |  | 2 years | 
| target vessel failure | progression of studied stenosis of non-culprit artery | 2 years | 
| stroke |  | 2 years | 
| hospitalization for heart failure |  | 2 years | 
| changes of left ventricular ejection fraction |  | 2 years | 
| hospitalization for unstable angina pectoris |  | 2 years | 
| outcomes of questionnaire regarding angina pectoris |  | 2 years | 
| target vessel revascularization | non infarct artery | 2 years | 
| target lesion revascularization | non infarct artery | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, primary PCI, non-infarct, non-culprit lesion, CABG