MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial

Study Overview
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Brief Summary
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The primary objective of the trial is to compare, in patients presenting with ST segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of immediate complete revascularization of all significant coronary lesions versus culprit vessel only revascularization and staged percutaneous coronary intervention (PCI) of all significant coronary lesions (within 19 to 45 days), in a non-inferiority trial using a third generation, biodegradable-polymer, everolimus-eluting stent.

Detailed Description
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An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD in stable hemodynamic conditions, undergoing after successful PCI of the culprit lesion either (1:1 randomization) immediate revascularization of all additional target lesions during the index procedure or staged PCI of all additional target lesions (within 19 to 45 days) using the Boston Scientific Synergy™ stent. The goal of this trial is to compare two treatment strategies that are currently performed in clinical practice: immediate complete revascularization versus staged complete revascularization in patients with STEMI and MVD. Patients randomized to immediate complete revascularization will have treated during the index procedure, after revascularization of the culprit lesion, all significant non-culprit coronary lesions. Patients randomized to staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized after 19-45 days for complete revascularization of all significant non-culprit coronary lesions. For both groups, lesion are considered significant when causing a ≥70% diameter stenosis by visual estimation in at least two projections on the coronary angiogram.

Official Title
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MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial

Conditions
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ST-elevation Myocardial Infarction, Multivessel Coronary Disease

Intervention / Treatment
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* Procedure: Staged complete PCI
* Procedure: Immediate complete PCI
* Device: Synergy™ stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) Suitability for PCI from femoral or radial access Coronary anatomy suitable for complete coronary revascularization with Synergy® stent implantation Identifiable culprit lesion/artery At least one non-culprit coronary stenosis ≥ 70% in at least two projections, in a vessel with a lumen diameter ≥2.25 - ≤5.75 mm, other than the culprit artery TIMI Flow 3 or TIMI flow 2 after revascularization of the culprit artery Stable hemodynamics at the end of the culprit vessel revascularization Exclusion Criteria: Inability to give informed consent Cardiogenic shock Prolonged resuscitation >10 min General unsuitability for PCI Need for emergency CABG Previous CABG Planned hybrid revascularization Coronary artery dissection STEMI due to ST Previous documented allergic reaction to everolimus or to any stent material Severe mechanical complication of acute myocardial infarction Pre-existing severe renal failure (eGFR <30 mL/min) or renal replacement therapy Chronic total occlusion of a major coronary artery Left main stem stenosis ≥50% or left main stem equivalent (ostial left anterior descending and ostial circumflex stenosis ≥70%) In-stent restenosis Panned coronary, cerebrovascular, or peripheral arterial revascularization Planned cardiac or major surgery Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 Inhibitor for at least 90 days, except for patients on oral anticoagulation Known pregnancy at the time of inclusion Participation in another clinical study with an investigational product Life expectancy <1 year

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: Staged complete PCI<br>Patients randomized to staged complete PCI will have treated during the index admission only the culprit lesion and they will be hospitalized after 19-45 days, to complete the coronary revascularization on all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent. | Procedure: Staged complete PCI<br>* During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 19-45 days to undergo PCI of all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.<br>Device: Synergy™ stent<br>* Bioabsorbable Polymer Drug-Eluting Stent<br>|
| Experimental: Immediate complete PCI<br>Patients randomized to immediate complete PCI will have treated immediately after the revascularization of the culprit lesion during the index procedure all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent. | Procedure: Immediate complete PCI<br>* During the index procedure, patients will have treated with primary PCI the culprit lesion, as well as all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.<br>Device: Synergy™ stent<br>* Bioabsorbable Polymer Drug-Eluting Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is a composite of all-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year |  | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death, non-fatal myocardial infarction, unplanned ischemia-driven revascularization, hospitalization for heart failure, and stroke | Primary endpoint | 6 months | 
| All-cause death | Single components of the primary endpoint | 6 months, 1 year | 
| Non-fatal myocardial infarction | Single components of the primary endpoint | 6 months, 1 year | 
| Unplanned ischemia-driven revascularization | Single components of the primary endpoint | 6 months, 1 year | 
| Hospitalization for heart failure | Single components of the primary endpoint | 6 months, 1 year | 
| Stroke | Single components of the primary endpoint | 6 months, 1 year | 
| Target lesion revascularization (TLR) |  | 6 months, 1 year | 
| Target vessel revascularization (TVR) |  | 6 months, 1 year | 
| Non-cardiovascular death |  | 6 months, 1 year | 
| Cardiac death |  | 6 months, 1 year | 
| Cardiovascular death |  | 6 months, 1 year | 
| Cardiac death or myocardial infarction |  | 6 months, 1 year | 
| All-cause death or myocardial infarction |  | 6 months, 1 year | 
| Stent thrombosis |  | 6 months, 1 year | 
| Acute renal insufficiency or dialysis |  | 6 months, 1 year | 
| Procedural success |  | 6 months, 1 year | 
| Bleeding event (BARC definition) |  | 6 months, 1 year | 
| Quality of life (EQ-5D questionnaire) |  | 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-elevation Myocardial Infarction, Multivessel coronary disease, Immediate complete coronary revascularization, Staged complete coronary revascularization, Percutaneous coronary intervention, Biodegradable-polymer everolimus-eluting stent