Bifurcation Left Main Stenting with or without intracoronary imaging: Outcomes From the EBC MAIN trial

Background The impact of intracoronary imaging on outcomes, after provisional versus dual-stenting for bifurcation left main (LM) lesions, is unknown. Objectives We investigated the effect of intracoronary imaging in the EBC MAIN trial (European Bifurcation Club Left Main Coronary Stent study). Methods 467 patients were randomised to dual-stenting or a stepwise provisional strategy. 455 patients were included. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was undertaken at the operator’s discretion. The primary endpoint was death, myocardial infarction or target vessel revascularisation at 1-year. Results Intracoronary imaging was undertaken in 179 patients (39%; IVUS n=151, OCT n=28). As a result of IVUS findings, operators re-intervened in 42 procedures. The primary outcome did not differ with intracoronary imaging versus angiographic-guidance alone (17% vs. 16%; odds ratio (OR): 1.09 [95% confidence interval (CI): 0.66-1.82] p=0.738), nor for re-intervention based on IVUS versus none (14% vs.16%; OR: 0.86 [95% CI: 0.35-2.12] p=0.745). With angiographic-guidance only, primary outcome events were more frequent with dual versus provisional stenting (21% vs. 10%; OR: 2.24 [95% CI: 1.13-4.45] p=0.022). With intracoronary imaging, there were numerically fewer primary outcome events with dual versus provisional stenting (13% vs. 21%; OR: 0.54 [95% CI: 0.24-1.22] p=0.137). Conclusions In EBC MAIN, the primary outcome did not differ between patients who did or did not have intracoronary imaging. However, in patients without intracoronary imaging, outcomes were worse with a dual-stent than provisional strategy, and when intracoronary imaging was used, there was a trend toward better outcomes with the dual-stent than provisional strategy. Condensed abstract We investigated whether intracoronary imaging during LM bifurcation stenting was associated with less death, myocardial infarction and revascularisation at 1 year, for patients undergoing systematic dual versus stepwise provisional stenting. We included 455 patients from the EBC MAIN trial; 39% had intracoronary imaging. Overall, outcomes were similar between patients who did or did not have intracoronary imaging. In those with angiographic guidance only, outcomes were worse with dual versus provisional stenting (21% vs. 10%; OR: 2.24 [95% CI: 1.13-4.45] p=0.022). In those with intracoronary imaging, there was a trend toward better outcomes with dual versus provisional stenting (13% vs. 21%). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial [ClinicalTrials.gov][1] Identifier [NCT02497014][2] ### Funding Statement This work was supported by the Educational and Research Grant from Medtronic Europe. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The trial complied with the Declaration of Helsinki and the study protocol was approved by the relevant authorities in all countries involved in the study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data is available in the manuscript * IVUS : intravascular ultrasound LM : Left main MACE : major adverse cardiac events MI : myocardial infarction OCT : optical coherence tomography OR : odds ratio PCI : percutaneous coronary intervention SD : standard deviation TVR : target vessel revascularization TIMI : Thrombolysis in Myocardial Infarction [1]: https://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02497014&atom=%2Fmedrxiv%2Fearly%2F2023%2F02%2F07%2F2023.02.03.23285434.atom