Safety and efficacy of self‐apposing Stentys drug‐eluting stent in left main coronary artery PCI: Multicentre LM‐STENTYS registry

Wańha, Wojciech; Mielczarek, Maksymilian; Smołka, Grzegorz; Roleder, Tomasz; Jaguszewski, Miłosz; Ciećwierz, Dariusz; Tomasiewicz, Brunon; Kübler, Piotr; Gorol, Jarosław; Chmielecki, Michal; Bartuś, Stanisław; Navarese, Eliano Pio; Kasprzak, Michał; Sukiennik, Adam; Kubica, Jacek; Lekston, Andrzej; Hawranek, Michał; Reczuch, Krzysztof; Gruchała, Marcin; Ochała, Andrzej; Wojakowski, Wojciech

doi:10.1002/ccd.27876

Cited by 5 publications

(8 citation statements)

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“…Xposition S as shown by the low rate of POT or FKB reported in this study and also in previous studies evaluating a self-apposing stent in ULMCA. 3,5 Although this deviates from the EBC consensus statement which recommends these procedural steps, 8…”

Section: Stent Optimization Techniques Are Deemed Less Essential Withmentioning

confidence: 87%

“…Xposition S also allows treatment of large vessels, such as can be encountered in most LMCA lesions. The device was studied in a broad set of lesions, including LM lesions, showing promising results. The Xposition S for TReatment of UNprotected left main Coronary artery disease (TRUNC; http://ClinicalTrials.gov Identifier: NCT02800837) is the first large prospective study to evaluate the acute and long‐term results that can be achieved with this technology in patients with ULMCA lesions.…”

Section: Introductionmentioning

confidence: 99%

“…In the MATISSE retrospective study,3 151 patients were treated with Xposition S for ULMCA lesions, reporting on a MACE rate of 9.3% at 9 months follow-up, with 1.3% cardiac death, 2.6% target-vessel related MI, and 5.3% TLR. In the LM-STENTYS retrospective Polish registry,5 175 LM patients were treated with Xposition S and subsequently divided into stable angina and acute coronary syndrome (ACS) groups. At 12 months follow-up, MACCE occurred in 12.0% of patients, respectively divided in 3.4% for stable patients and 16.2% for ACS patients.…”

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confidence: 99%

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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

Briguori

Tamburino

Jessurun

et al. 2019

Cathet Cardio Intervent

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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. 1 | INTRODUCTION Although coronary artery bypass grafting (CABG) is the historical gold standard, recent randomized studies suggest that percutaneous coronary intervention (PCI) is now a valid alternative for selected patients with unprotected left main coronary artery (ULMCA) disease. 1 In this complex population, the use of conventional balloon-expandable stents may present technical limitations, due to a fixed stent size, which

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Section: Stent Optimization Techniques Are Deemed Less Essential Withmentioning

confidence: 87%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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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

Briguori

Tamburino

Jessurun

et al. 2019

Cathet Cardio Intervent

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“…SXS was first performed in acute myocardial infarction, 25 followed by extension indication to coronary bifurcation, 26,27 and LM bifurcation. 28,29 Combination of OCT pre-and post-SXS implantation yielded better stent apposition and clear stent edge as demonstrated in better outcomes. 12,30,31 In our case, we applied OCT from the beginning of the case for MLA measurement, vessel sizing both distal shoulder in the proximal LAD and at the body LM.…”

Section: Discussionmentioning

confidence: 98%

Case Report: Dedicated Distal Left Main Coronary Stent Implantation ─Simplicity and Achievable Outcome

Tresukosol

2022

bkkmedj

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An 81-year-old Vietnamese man presented with worsening angina, with previous coronary angiography and intravascular ultrasonography findings with ostial left anterior descending artery (LAD) narrowing. He flew to our center for a second opinion. We offered intracoronary optical coherence tomography (OCT) evaluation for the measurement of critical ostial LAD, minimal lumen area (MLA). Provisional stent implantation to left main (LM) bifurcation (MEDINA 0,1,0) with dedicated self-apposing stent was performed with good angiographic result and mid-term follow up without major adverse event.

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“…of the main proximal vessel and the distal proximal vessel -due to the special properties of this stent. The stent Stentys (Stentys, France) is a self-apposing device constructed of nickel and titanium alloy characterized by the ability to push externally, increasing its dimensions only upon reaching the vessel wall, or a predictable maximal diameter dependent on the size of the device used [9].…”

Section: Angiographic Characteristicsmentioning

confidence: 99%

Four-Year Outcomes of Unprotected Left Main Lesion PCI with Self-Apposing Stents versus Balloon-Expandable Stents

Predescu

Bucşa

Croitoru

et al. 2022

Romanian Journal of Cardiology

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Background Left main percutaneous coronary intervention (PCI) has been established as an effective and safe treatment option for left main coronary artery disease. There are data suggesting that different stent platforms can impact the outcomes after left main PCI. The aim of current study was to compare the four-year outcomes of patients with left main stenosis treated by PCI with a balloon-expandable stent or a self-apposing stent. Methods and Results A total of 146 patients with left main stenosis treated by PCI were included, of which 84 (57.5%) had balloon-expandable stents (Group A) and 62 (42.5%) had self-apposing stents (Group B). Baseline SYNTAX scores were higher in Group A than in Group B. Proximal optimization technique was used more often in Group A (45.2% in Group B vs 81.4% in Group A, p<0.001). The same observations were made for kissing balloon postdilation (30.6% Group B vs 62.7% in Group A, p<0.001). Procedural success with TIMI 3 flow was achieved in similar proportions in both groups. Mortality rate and MACE rates at 4-year follow-up were higher in Group B compared to Group A but have not reached statistical significance in univariable or multivariable analysis. Implantation of a self-apposing stent has been an independent predictor for target lesion revascularization rate (TLR) in multivariable analysis (HR 0.06, CI − 1.11–11.7, =0.03). Conclusions In our study, TLR rate was significantly higher in patients with left main lesion treated by PCI with self-apposing stents.

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Safety and efficacy of self‐apposing Stentys drug‐eluting stent in left main coronary artery PCI: Multicentre LM‐STENTYS registry

Cited by 5 publications

References 30 publications

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

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

Case Report: Dedicated Distal Left Main Coronary Stent Implantation ─Simplicity and Achievable Outcome

Four-Year Outcomes of Unprotected Left Main Lesion PCI with Self-Apposing Stents versus Balloon-Expandable Stents

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