Comparison of single-stent and double-stent strategies for stenting a complex bifurcation lesion of the left main coronary artery in hemodynamically stable patients with acute coronary syndrome. Randomized study protocol (non-inferiority)

Abstract

To date, a single­stent strategy for stenting bifurcation lesions is considered the most optimal and is recommended for routine use. However, there are complex lesions that are unique in terms of morphological and anatomical features. Such lesions are not clearly defined in literature and may require an alternative approach to stenting. In this study, a complex bifurcation lesion of the left main coronary artery is presented, as well as a prospective randomized analysis of immediate and long­term outcomes of two approaches to stenting such lesions (single­stent and double­stent) in hemodynamically stable patients with acute coronary syndrome. Objective. To perform a comparative analysis of intraoperative, immediate and long­term outcomes of single­stent and double­stent strategies for stenting a complex bifurcation lesion of the left main coronary artery (LMCA) in hemodynamically stable patients with acute coronary syndrome (ACS). Materials and methods. To the open prospective randomized single­center (non­inferiority) study it is planned to enroll 114 hemodynamically stable patients with ACS (n=114) and complex (according to study criteria) bifurcation lesions of the LMCA; patients will undergo a single­stent or double­stent strategy of percutaneous coronary intervention (PCI) with implantation of drug­eluting stents. Randomization into two groups will be performed after coronary angiography, confirmation of eligibility (checking for inclusion criteria and exclusion criteria), and signing of informed consent; group 1 ­ single­stent stenting strategy; group 2 ­ double­stent stenting strategy. The total duration of the study will be 52 weeks, with mandatory telephone calls on 30th (±3 days) and 364th (±3 days) day after PCI and the final in­person visit after the entire follow­up period. Over the course of the study, patients will receive optimal drug therapy according to clinical recommendations. During the follow­up period, information will be collected on the clinical status of patients, events in the combined control points, compliance/adjustment of drug therapy. During in­person visit, patients will undergo multispiral computed tomography of coronary arteries. Combined primary endpoint: cardiac death, non­fatal myocardial infarction, acute cerebrovascular accident and repeated revascularization of target vessel. Combined secondary endpoint: thrombosis and restenosis of the stent. Conclusion. In our study, a bifurcation lesion of the LMCA, unique in terms of morphological and anatomical criteria, will be identified in hemodynamically stable patients with ACS. This is a complex lesion that may initially require double­stent approach to stenting, which differs from the recommended single­stent strategy. Keywords: percutaneous coronary intervention, bifurcation stenting, single­stent technique, double­stent technique, culotte­stenting, crush­stenting, TAP­stenting, complex lesion, acute coronary heart disease