Prospective evaluation of drug eluting self‐apposing stent for the treatment of unprotected left main coronary artery disease: 1‐year results of the TRUNC study

Abstract

Objectives: To assess long-term safety and efficacy of the Xposition S self-apposing stent in the treatment of unprotected left main coronary artery (ULMCA) disease. Background: Percutaneous intervention with stents has emerged as a valid alternative to surgical revascularization to treat ULMCA disease. Conventional balloon-expandable stents face technical challenges, particularly in large left main diameter requiring extensive optimization and side branch access in distal bifurcation. Xposition S allows for optimal apposition, bridging diameter differences, and allows expansion to vessel diameters up to 6.0 mm. Methods: Between June 2016 and July 2017, 205 patients were enrolled in this international, prospective, multicenter registry. Patients with SYNTAX score ≥ 33 or recent STEMI were excluded. IVUS during procedure was performed in a prespecified subgroup of 50 patients. The primary clinical endpoint was 12 months Target lesion failure (TLF) and the primary efficacy endpoint was angiographic success. Results: Distal left main bifurcation was involved in 92.7%, treated with provisional approach in most cases (79.4%). TLF rate at 12 months was 8.3%, which was defined as a composite of cardiac death (2.0%), target-vessel MI (2.9%), and TLR (5.4%). Most revascularizations occurred at SB ostium. IVUS analysis demonstrated optimal stent apposition with only one reported malapposition and promising poststenting minimal stent area measures. Conclusions: The TRUNC study confirms that Xposition S self-apposing stent is a valid and feasible option for the treatment of ULMCA disease. Such results were reached without the systematic need of stent optimisation techniques, focusing mainly on lesion treatment. 1 | INTRODUCTION Although coronary artery bypass grafting (CABG) is the historical gold standard, recent randomized studies suggest that percutaneous coronary intervention (PCI) is now a valid alternative for selected patients with unprotected left main coronary artery (ULMCA) disease. 1 In this complex population, the use of conventional balloon-expandable stents may present technical limitations, due to a fixed stent size, which

How to deal with vessel diameter mismatch in left main bifurcation stenting

“…5), and it was not available in our cath lab at that time. Conversely, the SAS can manage ectatic/aneurysmatic segments, as well as tackle a large diameter mismatch across a bifurcation, since contiguous portions of its mesh can adapt to sudden changes in vessel calibre 11 . It can be part of a provisional or two-stent initial strategy.…”

“…Conversely, the SAS can manage ectatic/aneurysmatic segments, as well as tackle a large diameter mismatch across a bifurcation, since contiguous portions of its mesh can adapt to sudden changes in vessel calibre. 11 It can be part of a provisional or two-stent initial strategy. However, its unique splitable-sheath design requires thorough step-by-step PCI planning, where intracoronary imaging plays an essential role.…”