Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI

Study Overview
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Brief Summary
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To determine whether, on a background of optimal medical therapy, including ticagrelor, opening of all suitable narrowings or blockages found at the time of primary PCI for an acute heart attack is better than treating only the culprit lesion in patients with multi-vessel disease.

Detailed Description
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To determine if a strategy of multivessel revascularization involving PCI of all suitable non-infarct related artery lesions plus optimal medical therapy is superior to a strategy of optimal medical therapy alone in reducing (1) the composite outcome of cardiovascular (CV) death or new myocardial infarction (MI), or (2) the composite of CV death, new MI or ischemia driven revascularization (IDR) in patients with multivessel disease who have undergone early successful culprit lesion PCI for STEMI.

Official Title
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Randomized Comparative Effectiveness Study of Complete vs Culprit-only Revascularization Strategies to Treat Multi-vessel Disease After Early Percutaneous Coronary Intervention (PCI) for ST-segment Elevation Myocardial (STEMI) Infarction

Conditions
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Acute Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Complete Revascularization Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis AND Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has: At least 70% diameter stenosis (visual estimation) or At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80 Exclusion Criteria: Planned revascularization of non-culprit lesion Planned surgical revascularization Non-cardiovascular co-morbidity reducing life expectancy to < 5 years Any factor precluding 5 year follow-up Prior Coronary Artery Bypass Graft (CABG) 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Complete Revascularization Strategy<br>Complete Revascularization Strategy (Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy): Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions. All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose acetylsalicylic acid (ASA) and ticagrelor). | Procedure: Complete Revascularization Strategy<br>* Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions plus optimal medical therapy.<br>* Other names: Staged Non-Culprit Lesion PCI plus Optimal Medical Therapy;|
| No Intervention: Optimal Medical Therapy Alone<br>Culprit lesion only Revascularization Strategy (Optimal Medical Therapy Alone): No further revascularization of non-culprit lesions. All patients, regardless of randomized treatment allocation will receive optimal medical therapy consisting of risk factor modification and use of evidence-based therapies (including low dose ASA and ticagrelor). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Cardiovascular death or new myocardial Infarction | Co-primary outcome: CV death or new MI | over duration of follow-up (average of approximately 4 years) | 
| Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization | Co-primary outcome: CV death, new MI or IDR | over duration of follow-up (average of approximately 4 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of CV death, new MI, ischemia-driven revascularization or hospitalization for unstable angina or heart failure |  | Over duration of follow-up (average of approximately 4 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, ticagrelor, multi-vessel disease, culprit lesion