Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease

Study Overview
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Brief Summary
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Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment elevation myocardial infarction (STEMI) and has been associated to a worse prognosis. Multivessel revascularization offers a myriad of potential advantages as enhance of the collateral blood flow, greater myocardial salvage, the stabilization of other lesions that can be potentially vulnerable, and the achievement of a complete revascularization, factor that is associated with a better prognosis. On the other hand, the prolongation of procedural duration, the hazard of contrast induced nephropathy and the peri-procedural complications can limit the widespread of this practice. To date, very few observational studies have focused in the multivessel revascularization with disparity of results. Whereas ones have observed an increase of adverse cardiovascular events and thus not recommend it, others have shown neutral results. Stress echocardiography has been shown to be an adequate technique for the diagnosis of coronary artery disease and could be an appropriate tool for selecting the lesions that need to be revascularized because they induce large areas of ischemia. However, this technique has also limitations like the high operator-dependence. Therefore, the investigators sought to study if the complete multivessel revascularization of patients with STEMI treated by means of primary percutaneous coronary intervention (PCI) has an impact on prognosis compared to a strategy of treating only those non-culprit lesions that produce large areas of ischemia in a stress test.

Official Title
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Complete Revascularization Or streSS Echo in Patients With Multivessel Disease and ST-segment Elevation Acute Myocardial Infarction

Conditions
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Myocardial Infarction, Angioplasty, Transluminal, Percutaneous Coronary, Echocardiography, Stress

Intervention / Treatment
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* Procedure: complete multivessel revascularization
* Procedure: stress echocardiography and revascularization if required


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Typical chest pain lasting >30 minutes with ST-segment elevation >=1mm in >=2 contiguous ECG leads or left bundle branch block and presentation < 48 hours since symptom onset. Patients undergoing rescue PCI Patients with effective lysis and coronary angiography in less than 24 hours Presence of other lesion >=70% in a non-culprit artery. Informed consent Exclusion Criteria: Significant left main disease Lesions in vessels < 2 mm Lesions in branches of a main epicardial coronary artery and short irrigation territory Previous coronary artery bypass graft (CABG) Any coronary intervention in the previous month Cardiogenic shock Anatomic features no suitable for coronary intervention Pregnancy

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: complete multivessel revascularization<br> | Procedure: complete multivessel revascularization<br>* After a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission<br>|
| Active Comparator: stress echo guided revascularization<br> | Procedure: stress echocardiography and revascularization if required<br>* after successful primary PCI, this group will undergo a stress echo to evaluate the significance of non-culprit lesions. If large area of ischemia is demonstrated, the artery supplying that are will be revascularized.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute renal failure (contrast induced nephropathy) |  | Admission | 
| Cost analysis of both strategies |  | 1 year | 
| Death | cardiovascular death | one year | 
| re-myocardial infarction |  | one year | 
| revascularization of any vessel |  | one year | 
| admission due to heart failure |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, primary angioplasty, multivessel disease, stress echocardiography