Abstract
BackgroundPrimary percutaneous coronary intervention (PCI) for patients presenting with acute myocardial infarction (AMI) caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major adverse cardiovascular events. Deferred stent implantation may improve prognosis of primary PCI by reducing distal embolization and no-reflow phenomenon. There is no randomized clinical trial focusing on the effect and outcome of deferred stent implantation on primary PCI for left main coronary artery occlusion in contrast with conventional strategy.MethodsThe Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction due to Unprotected Left Main Coronary Artery Occlusion (OPTIMAL) study (ClinicalTrials.gov Identifier: NCT03282773) is an open-label, randomized, multicenter clinical trial in which 480 patients presenting with AMI caused by left main coronary artery occlusion recruited from 30 hospitals in mainland China will be randomly assigned 1:1 to immediate stenting or deferred stenting (scheduled 4–10 days after primary angioplasty) groups. The primary endpoint is a composite of all-cause mortality or recurrent myocardial infarction at 30 days after randomization. The secondary outcomes include all-cause mortality, cardiac death, recurrent myocardial infarction, and unplanned target vessel revascularization at 30 days, 6 months, and 12 months.DiscussionThe OPTIMAL study is designed to compare the clinical performance of deferred stenting with that of immediate stenting for AMI caused by left main coronary artery occlusion.Trial registrationClinicalTrials.gov Identifier: NCT03282773. Registered on 10 September 2017.
Highlights
Primary percutaneous coronary intervention (PCI) for patients presenting with acute myocardial infarction (AMI) caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major adverse cardiovascular events
We hypothesize that patients with left main coronary artery occlusion–induced AMI (LM-AMI) receiving deferred stent implantation will have improved short-term and long-term clinical outcomes compared with those receiving immediate stenting
Patients unable or unwilling to sign the informed consent form aAMI is defined in accordance with the Third Universal Definition of Myocardial Infarction [20] bLife expectancy here is the mean number of years of life remaining, which is estimated through the medical history and clinical parameters by the investigators of each center
Summary
Objectives and study design The aim of this open-label, multicenter RCT is to compare immediate stenting with deferred stenting for LM-AMI in 30 hospitals in China. Patients unable or unwilling to sign the informed consent form aAMI is defined in accordance with the Third Universal Definition of Myocardial Infarction [20] bLife expectancy here is the mean number of years of life remaining, which is estimated through the medical history and clinical parameters by the investigators of each center This criterion is suitable only for patients who have a malignant tumor, end-stage organ failure or other terminal diseases. The CRA has access to all documents in the database, including original medical history, images, and CRFs. Data correctness will be assessed and serious adverse events will be reported to the ethics committee of the particular center and Zhongshan Hospital. PCI or CABG is ready for any patients presenting with recurrent ischemia and MI after stent implantation in the hospital
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