Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial

Yang Gao, Feng Zhang, Chenguang Li, Yuxiang Dai, Ji'e Yang, Ya'nan Qu, Juying Qian, Junbo Ge, OPTIMAL trial investigators, Yang Gao, Feng Zhang, Chenguang Li, Yuxiang Dai, Ji'e Yang, Ya'nan Qu, Juying Qian, Junbo Ge, OPTIMAL trial investigators

Abstract

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.

Keywords: Acute myocardial infarction; Deferred stent implantation; Percutaneous coronary intervention.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol and other associated documents have been approved by the ethics committee of Zhongshan Hospital (Shanghai). The reference number is B2017–104. Written informed consent will be provided by patients before enrollment.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
OPTIMAL study design flowchart. Abbreviations: AMI acute myocardial infarction, OPTIMAL Optimal Strategy of Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction due to Unprotected Left Main Coronary Artery Occlusion
Fig. 2
Fig. 2
Time schedule of the study. Abbreviation: PPCI primary percutaneous coronary intervention

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