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.
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
06
03
2019
revised:
26
09
2019
accepted:
26
10
2019
pubmed:
7
11
2019
medline:
3
2
2021
entrez:
8
11
2019
Statut:
ppublish
Résumé
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. 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. 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. 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. 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.
Sections du résumé
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.
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
E142-E148Informations de copyright
© 2019 Wiley Periodicals, Inc.
Références
Neumann FJ, Sousa-Uva M, Ahlsson A, et al. ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2018;2018:1-96.
Kumar N, Raveen Kandan S, Rahbi H, et al. Single-Centre experience of STENTYS Xposition S in treatment of left main stem lesions. Expert Rev Med Devices. 2017;14(7):577-582.
Cortese B, Montefusco A, D'Ascenzo F, et al. Clinical performance of a dedicated self-apposing stent for the treatment of left main stem disease. Results of the left Main AngioplasTy wIth a Self-apposing StEnt-the MATISSE study. Cardiovasc Revasc Med. 2018;19:831-836.
Montefusco A, D'Ascenzo F, Gili S, et al. Self-expandable sirolimus-eluting stents compared to second-generation drug-eluting stents for the treatment of the left main: a propensity score analysis from the SPARTA and the FAILS-2 registries. Catheter Cardiovasc Interv. 2018;93:1-8.
Wanha W, Mielczarek M, Smolka G, et al. Safety and efficacy of self-apposing stentys drug-eluting stent in left main coronary artery PCI: multicentre LM-STENTYS registry. Catheter Cardiovasc Interv. 2018;2018:e27876.
Naber C, Pyxaras S, Nef H, et al. Final results of a self-apposing paclitaxel-eluting stent for the percutaneous treatment of de novo lesions in native bifurcated coronary arteries study. EuroIntervention. 2015;11:356-358.
Koch K, Grundeken MJ, Vos NS, et al. One-year clinical outcomes of the STENTYS self-apposing® coronary stent in patients presenting with ST-segment elevation myocardial infarction: results from the APPOSITION III registry. EuroIntervention. 2015;10:264-271.
Flensted Lassen J, Burzotta F, Banning AP, et al. Percutaneous coronary intervention for the left main stem and other bifurcation lesions: 12th consensus document from the European bifurcation Club. EuroIntervention. 2018;13:1540-1543.
Gershlick A, Kandzari D, Banning A, et al. Outcomes after left Main percutaneous coronary intervention versus coronary artery bypass grafting according to lesion site. Results from the EXCEL trial. JACC: Cardiovasc Interv. 2018;11:13.
Kang SJ, Ahn JM, Song H, et al. Comprehensive intravascular ultrasound assessment of stent area and its impact on restenosis and adverse cardiac events in 403 patients with unprotected left Main disease. Circ Cardiovasc Interv. 2011;4:562-569.
Kim S, Maehara A, Banning A, et al. Frequency and impact of acute stent deformation after PCI of left Main coronary artery disease: an EXCEL trial intravascular ultrasound substudy. JACC. 2017;70(18 Supplement):B19.
Makikallio T, Holm NR, Lindsay M, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016;388:2743-2752.
Stone GW, Sabik JF, Serruys PW, et al. Everolimus-eluting stents or bypass surgery for left main coronary artery disease. N Engl J Med. 2016;375:2223-2235.
Chieffo A, Tanaka A, Giustino G, et al. The DELTA 2 registry: a Multicenter registry evaluating percutaneous coronary intervention with new-generation drug-eluting stents in patients with obstructive left Main coronary artery disease. J Am Coll Cardiol Intv. 2017;10:2401-2410.