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

Fudan University

Status: Unknown

Conditions: Percutaneous Coronary Intervention; Acute Myocardial Infarction

Treatments: Device: Deferred stent implantation; Device: Immediate stent implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03282773

B2017-104

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Deferred stent implantation

Experimental group

Description:

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

Treatment:

Device: Deferred stent implantation

Immediate stent implantation

Active Comparator group

Description:

Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery

Treatment:

Device: Immediate stent implantation