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2.
Catheter Cardiovasc Interv ; 96(2): E142-E148, 2020 08.
Article in English | MEDLINE | ID: mdl-31696618

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.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Coronary Artery Disease/therapy , Drug-Eluting Stents , Self Expandable Metallic Stents , Aged , Angioplasty, Balloon, Coronary/adverse effects , Coronary Artery Disease/diagnostic imaging , Europe , Female , Humans , Male , Middle Aged , Prospective Studies , Prosthesis Design , Registries , Single-Blind Method , Time Factors , Treatment Outcome
3.
Catheter Cardiovasc Interv ; 94(7): 966-971, 2019 Dec 01.
Article in English | MEDLINE | ID: mdl-30903739

ABSTRACT

OBJECTIVES: The aim is to assess the experience in the Netherlands using the Xposition S self-apposing stent in complex coronary lesions in clinical practice. BACKGROUND: Treatment of complex coronary lesions could be accompanied with stent sizing difficulties and complications, particularly due to vessel overdilation or stent underexpansion. The self-apposing feature of the Xposition S stent (STENTYS, Paris, France) supports good strut apposition in complex anatomies and allows for an increase in diameter after implantation. METHODS: In this real-world registry, data from patients treated with Xposition S in four Dutch clinical sites were prospectively collected and analyzed. Any patient suitable for implantation with Xposition S according to current recommendations was enrolled. Primary endpoint was major adverse cardiac events (MACE) at 1 year. RESULTS: Between 2015 and 2018, data from 251 patients were collected. Clinical presentation was an acute coronary syndrome in majority of the patients (76.9%). Main angiographic indications were lesions in aneurysmatic or ectatic vessels (32.3%), thrombus containing lesions (13.1%), and bifurcation/left main stenosis (10.4%). Most of the target lesions (TLs) were classified as AHA/ACC Type C (53.6%). Despite lesion complexity, device was successfully implanted at TL in 96.8%. MACE rate, reported on patients having completed 1-year follow-up (n = 203), was 6.6%, with low rate of definite/probable stent thrombosis (1.0%). CONCLUSIONS: In clinical practice of several Dutch sites, STENTYS Xposition S showed good procedural results and low 1-year clinical events rate, despite complex coronary anatomy.


Subject(s)
Acute Coronary Syndrome/therapy , Angioplasty, Balloon, Coronary/instrumentation , Coronary Artery Disease/therapy , Drug-Eluting Stents , Acute Coronary Syndrome/diagnostic imaging , Aged , Angioplasty, Balloon, Coronary/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Thrombosis/etiology , Female , Humans , Male , Middle Aged , Netherlands , Prospective Studies , Prosthesis Design , Registries , Time Factors , Treatment Outcome
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