In-hospital Versus After-discharge Complete Revascularization

Study Overview
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Brief Summary
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Patients with STEMI and multivessel disease in whom the culprit lesion has been successfully revascularized during prmimary PCI, will be randomized to in-hospital or after-discharge complete revascularization. The purpose of this study is to evaluate the impact of these two different strategies in terms of hospital stay.

Detailed Description
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STEMI patients with mutivessel disease are, after successful primary angioplasty, randomized 1:1 ratio to either in-hospital complete revascularization or after-discharge complete revascularization strategy. Eligible non-culprit coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses ≥70% or between ≥50% and <70 in proximal segments can be randomized. Patients in the in-hospital revascularization group will undergo to non-culprit percutaneous coronary intervention (PCI) at least 24 hours after ST-segment elevation myocardial infarction. On the other hand, patients in the after-discharge group will undergo to non-culprit PCI within 4-6 weeks after STEMI.

Official Title
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In-hospital Versus After-discharge Complete Revascularization in STEMI Patients With Multivessel Disease.

Conditions
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STEMI - ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Intervention / Treatment
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* Other: In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)
* Other: After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute onset of chest pain <12 hours duration. ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block. Culprit lesion in a major native vessel, with successful primary PCI. Presence of at least one non-culprit lesion more than or equal to 70% of stenosis in a vessel more than 2mm of diameter or more than or equal to 50% stenosis in proximal segments. The patient is able to give written consent for participation in the study. Exclusion Criteria: Pregnancy. Significant left main stenosis. Stent thrombosis. Chronic total occlusion. Severe stenosis of non-culprit vessels with distal flow less than TIMI3. Significant non-culprit stenosis no candidate to revascularization. Presence of valvulopathy candidate for cardiac surgery. Cardiogenic shock status at admission. The patient is not able to give written consent for participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: In-hospital complete revascularization group.<br>Patients will undergo to a complete revascularization of non-culprit lesions at least 24 hours after STEMI and before hospital discharge. | Other: In-hospital nonculprit-lesions percutaneous coronary intervention (PCI)<br>* To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure during index admission.<br>|
| Other: After-discharge complete revascularization group.<br>Patients will undergo to a complete revascularization of non-culprit lesions after hospital discharge within 4-6 weeks after STEMI. | Other: After-discharge nonculprit-lesions percutaneous coronary intervention (PCI)<br>* To perform percutaneous coronary intervention of non-culprit vessels in a staged procedure after hospital discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact in hospital stay | To evaluate the impact of two different revascularization strategies (in-hospital versus after-discharge) in terms of hospital stay (days) in patients with a STEMI and multivessel disease. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death, acute myocardial infarction or revascularization. | Composite of cardiovascular death, myocardial infarction, or ischemia driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two strategies. | 1 year | 
| Fractional flow reserve of angiographically moderate stenosis | Evaluate the presence of ischemia by analyzing the fractional flow reserve of angiographically moderate stenoses (≥50% and <70) in proximal segments of the anterior descending, circumflex, or right coronary artery. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, Multivessel, PCI