Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization

Study Overview
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Brief Summary
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In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.

Detailed Description
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STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR). Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR. Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.

Official Title
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Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

Conditions
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ST-elevation Myocardial Infarction, Multi Vessel Disease

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention
* Procedure: FFR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Acute onset of chest pain of < 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. MVD (non-culprit vessels with angiographic stenosis >50%) Successful primary PCI Exclusion Criteria: Pregnancy. Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast. Inability to understand information or to provide informed consent. Haemorrhagic diathesis or known coagulopathy. Stent thrombosis Significant left main stem stenosis Cardiogenic shock at admittance

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: Culprit lesion revascularization<br>Only the culprit lesion is treated whereas other study lesions are left un-treated. | Procedure: Percutaneous coronary intervention<br> <br> |
| Active Comparator: Full revascularization<br>Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR. | Procedure: Percutaneous coronary intervention<br> <br> Procedure: FFR<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death, myocardial infarction or revascularization | Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death or myocardial infarction |  | 1 year | 
| Hospitalization for acute coronary syndrome or acute heart failure |  | 1 year | 
| Angina status and quality of life |  | 1 year | 
| Infarct size in relation to area at risk as determined by MRI |  | 3 months | 
| Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions |  | 2 years | 
| Wall motion index (WMI) determined by echocardiography |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, MVD, Full revascularization, Culprit lesion revascularization only, Primary PCI