Optimal Strategy of Primary PCI for Left Main Coronary Artery Occlusion Induced AMI

Study Overview
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Brief Summary
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This study will compare clinical outcomes of immediate stent implantation with deferred stent implantation(4-10days after primary angiography) for patients presented with acute myocardial infarction due to left main coronary artery occlusion.

Detailed Description
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Primary percutaneous coronary intervention for patients presented with acute myocardial infarction caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major cardiac adverse events. Deferred stent implantation may improve prognosis of primary PCI through reducing distal embolization and no-reflow phenomenon. There is no randomized clinical trial focuses on the effect and outcome of deferred stent implantation on primary PCI for left main coronary artery occlusion in contrast with conventional strategy. This prospective, multicenter, randomized trial is aimed to compare immediate stenting with deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.

Official Title
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Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction Due to Unprotected Left Main Coronary Artery Occlusion

Conditions
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Acute Myocardial Infarction, Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Deferred stent implantation
* Device: Immediate stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of acute myocardial infarction occured within 12 hours Left main coronary artery occlusion confirmed by angiography Left main coronary artery occlusion (TIMI flow 0,1 or 2) confirmed by primary angiography, TIMI flow grade 3 achieved after pretreatment of thrombus aspiration or balloon dilatation Exclusion Criteria: Life expectancy less than 1 years Cardiogenic shock Chronic kidney disease, stage 4 by KDOQI(GFR<30ml/min) Contraindications to aspirin or other anti-platelet drugs Allergy to contrast agent, rapamycin or paclitaxel Patients who are included in other ongoing trials Pregnant female

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Deferred stent implantation<br>Drug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI | Device: Deferred stent implantation<br>* Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.<br>|
| Active Comparator: Immediate stent implantation<br>Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery | Device: Immediate stent implantation<br>* Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cardiac death and recurrent myocardial infarction | Recorded in follow-up | 30 days after primary angiography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization | Recorded in follow-up | 30 days after primary angiography | 
| Residual stenosis of left main coronary artery | Measured through angiography | Immediately after stent implantation and 12 months after primary angiography | 
| Left ventricular ejection fraction | Measured through echocardiogram | 30 days and 12 months after primary angiography | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myocardial infarction, percutaneous coronary intervention, deferred stent implantation