Key result
Deferred stent implantation will be compared to immediate stenting in the OPTIMAL trial to determine its effect on 30-day all-cause mortality or recurrent myocardial infarction in patients with left main coronary artery occlusion.
Why the study?
Primary PCI for AMI caused by left main coronary artery occlusion carries high mortality and MACE risk, and randomized trials evaluating deferred versus conventional immediate stenting were lacking.
Does deferred stenting reduce the composite of all-cause mortality or recurrent myocardial infarction in patients with acute myocardial infarction due to left main coronary artery occlusion compared to immediate stenting?
RCT (n=480)
Open-label
1:1
Yes
Does deferred stenting reduce the composite of all-cause mortality or recurrent myocardial infarction in patients with acute myocardial infarction due to left main coronary artery occlusion compared to immediate stenting?
The OPTIMAL trial protocol outlines a randomized study to determine if deferred stenting improves clinical outcomes compared to immediate stenting in patients with acute myocardial infarction caused by left main coronary artery occlusion.
Addresses gap in left main AMI stenting strategy; leaves open optimal timing until trial results emerge.
BACKGROUND: 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. 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. METHODS: The 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov Identifier: NCT03282773 . Registered on 10 September 2017.
No takes yet. Share an insight, caveat, or question.
Gao et al. (2019) conducted an RCT in Acute myocardial infarction due to unprotected left main coronary artery occlusion (n=480). Deferred stent implantation vs. Immediate stenting was evaluated on Composite of all-cause mortality or recurrent myocardial infarction at 30 days. Deferred stent implantation will be compared to immediate stenting in the OPTIMAL trial to determine its effect on 30-day all-cause mortality or recurrent myocardial infarction in patients with left main coronary artery occlusion.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: