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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
Author(s) -
Briguori Carlo,
Tamburino Corrado,
Jessurun Gillian A. J.,
MeyerGeßner Markus,
Reczuch Krzysztof,
Cortese Bernardo,
Maillard Luc,
Anthonio Rutger L.,
La Manna Alessio,
Morice MarieClaude,
Bouchez David,
Balland Anaïs,
Huynh ViPhong,
Baumbach Andreas
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28584
Subject(s) - medicine , stent , clinical endpoint , ostium , percutaneous coronary intervention , coronary artery disease , target lesion , radiology , surgery , cardiology , drug eluting stent , percutaneous , revascularization , restenosis , clinical trial , myocardial infarction
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.