Dutch multicenter experience using the STENTYS Xposition S self-apposing stent in complex coronary lesions.
Acute Coronary Syndrome
/ diagnostic imaging
Aged
Angioplasty, Balloon, Coronary
/ adverse effects
Coronary Artery Disease
/ diagnostic imaging
Coronary Thrombosis
/ etiology
Drug-Eluting Stents
Female
Humans
Male
Middle Aged
Netherlands
Prospective Studies
Prosthesis Design
Registries
Time Factors
Treatment Outcome
complex PCI, coronary artery disease
percutaneous coronary intervention
stent design/structure/coatings
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:
01 Dec 2019
01 Dec 2019
Historique:
received:
19
10
2018
accepted:
01
03
2019
pubmed:
25
3
2019
medline:
2
9
2020
entrez:
24
3
2019
Statut:
ppublish
Résumé
The aim is to assess the experience in the Netherlands using the Xposition S self-apposing stent in complex coronary lesions in clinical practice. 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. 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. 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%). 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.
Sections du résumé
OBJECTIVES
OBJECTIVE
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
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
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
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
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.
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
966-971Informations de copyright
© 2019 Wiley Periodicals, Inc.
Références
Koch KT, 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;11:264-271.
IJsselmuiden AJJ, Simsek C, Van Driel AG, et al. Comparison between the STENTYS self-apposing bare metal and paclitaxel-eluting coronary stents for the treatment of saphenous vein grafts (ADEPT trial). Neth Heart J. 2018;26:94-101.
Brugaletta S, Martin-Yuste V, Padró T, et al. Endothelial and smooth muscle cells dysfunction distal to recanalized chronic total coronary occlusions and the relationship with the collateral connection grade. J Am Coll Cardiol Intv. 2012;5:170-178.
Santos MC, Lin T, Barlis P. In-stent restenosis associated with stent malapposition: Seven year optical coherence tomography findings. Int J Cardiol. 2011;147:149-151.
Nakazawa G. Stent thrombosis of drug eluting stent: Pathological perspective. J Cardiol. 2011;58:84-91.
Souteyrand G, Amabile N, Mangin L, et al. Mechanisms of stent thrombosis analysed by optical coherence tomography: Insights from the national PESTO French registry. Eur Heart J. 2016;37:208-1216.
Amoroso G, van Geuns RJ, Spaulding C, et al. Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: Results from the APPOSITION I study. EuroIntervention. 2011;7:428-436.
van Geuns RJ, Tamburino C, Fajadet J, et al. Self-expanding versus balloon-expandable stents in acute myocardial infarction: Results from the APPOSITION II study: Self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012;5:1209-1219.
Lu H, IJsselmuiden AJ, Grundeken MJ, et al. First-in-man evaluation of the novel balloon delivery system STENTYS Xposition S for the self-apposing coronary artery stent: Impact on longitudinal geographic miss during stenting. EuroIntervention. 2016;11:1341-1345.
Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation. 2007;115:2344-2351.
Ng J, Foin N, Ang Y, et al. Over-expansion capacity and stent design model: An update with contemporary DES platforms. Int J Cardiol. 2016;221:171-179.
Windecker S, Serruys PW, Wandel S, et al. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularization (LEADERS): A randomised non-inferiority trial. Lancet. 2008;372:1163-1173.
Danzi GB, Chevalier B, Urban P, et al. Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: The NOBORI 2 study. EuroIntervention. 2012;8:109-116.