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Aims: The feasibility of offline optical coherence tomography (OCT) guidance in bifurcation (with either two-dimensional or three-dimensional images) and its potential benefits have been demonstrated in retrospective studies; however, these have not yet been investigated prospectively. The aim of this trial is to determine the superiority of online three-dimensional optical frequency domain imaging (3D-OFDI)- guided stenting to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition (ISA) at the bifurcation segment. Methods and results: The OPTIMUM trial is a randomised, superiority, multicentre clinical trial. The primary endpoint of this trial is the post-procedural percentage of malapposed struts assessed by OFDI in the main branch bifurcation region after final kissing balloon dilatation (FKBD). A total of 106 patients will be randomly allocated to either 3D-OFDI guidance or angiography guidance PCI. Bifurcation lesions will be treated with a provisional single-stent strategy using the Ultimaster sirolimus-eluting stent. Patients randomised to the 3D-OFDI guidance arm will undergo OFDI assessment in the main branch (MV) after rewiring into the jailed side branch following stent implantation, while in the angiography guidance arm re-crossing of a wire into the side branch will be performed using conventional fluoroscopic/angiographic guidance. In patients in the 3D-OFDI guidance arm, if the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm the re-crossing position. The proximal optimisation technique and FKBD are mandatory in this trial. The study will provide a 90% power to show superiority of 3D-OFDI guidance PCI compared with angiography-guided PCI. Conclusions: The OPTIMUM trial will be the first prospective, randomised trial to evaluate the efficacy and safety of online 3D-OFDI-guided PCI in bifurcation lesions. ClinicalTrials.gov Identifier: NCT02972489.

Aims: The purpose of the study was to investigate whether the favourable outcomes of state-of-the-art PCI in the SYNTAX II trial, demonstrated at one year, were maintained at two-year follow-up. Methods and results: The SYNTAX II study was a multicentre, single-arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in 454 patients with de novo three-vessel coronary artery disease, without left main disease. Clinical outcomes in SYNTAX II were compared to the predefined PCI (SYNTAX-I PCI) and coronary artery bypass graft (SYNTAX-I CABG) cohorts from the landmark SYNTAX trial (SYNTAX-I), selected on the basis of equipoise for long-term (four-year) mortality utilising the SYNTAX score II. At two years, major adverse cardiac and cerebrovascular events (MACCE: a composite of all-cause death, any stroke, myocardial infarction, or revascularisation) in SYNTAX II were significantly lower compared to SYNTAX-I PCI (13.2% vs. 21.9%, p=0.001). Furthermore, similar twoyear outcomes for MACCE were evident between SYNTAX II PCI and SYNTAX-I CABG (13.2% vs. 15.1%, p=0.42). Conclusions: At two years, clinical outcomes with the SYNTAX II strategy remained superior to the predefined SYNTAX-I PCI cohort, and similar to the predefined SYNTAX-I CABG cohort.