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Catheter Cardiovasc Interv. 2019 Nov 6. doi: 10.1002/ccd.28584. [Epub ahead of print]

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 information

1
Mediterranea Cardiocentro, Naples, Italy.
2
Ferrarotto Hospital, University of Catania, Catania, Italy.
3
Treant Zorggroep, Emmen, the Netherlands.
4
Augusta Krankenhaus, Düsseldorf, Germany.
5
Medical University of Wrocław, Wroclaw, Poland.
6
Military Hospital, Wroclaw, Poland.
7
ASST Fatebenefratelli Sacco, Milano, Italy.
8
GCS ES Axium Rambot, Aix en Provence, France.
9
CERC, Massy, France.
10
STENTYS SA, Paris, France.
11
Barts Heart Centre, London, UK.

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.

PMID:
31696618
DOI:
10.1002/ccd.28584

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