Prospective multicentre study of carotid artery stenting using the MER (TM) Stent - the OCEANUS study-30-day and one-year follow-up results

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F20%3A43920065" target="_blank" >RIV/00216208:11120/20:43920065 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00064173:_____/20:N0000096

Výsledek na webu

<a href="https://doi.org/10.5114/aic.2019.91364" target="_blank" >https://doi.org/10.5114/aic.2019.91364</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.5114/aic.2019.91364" target="_blank" >10.5114/aic.2019.91364</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Prospective multicentre study of carotid artery stenting using the MER (TM) Stent - the OCEANUS study-30-day and one-year follow-up results

Popis výsledku v původním jazyce

Introduction: Constant technological progress in the field of carotid stenting translates into improved short-and long-term results of endovascular treatment. The introduction of a new generation, self-expanding, open-cell stent has provided a new treatment option in endovascular management of carotid stenosis. Aim: To evaluate 30-day and 1-year clinical outcomes of non-consecutive patients with high risk of carotid endarterectomy, who underwent 5F cylinder-tapered MER (TM) open-cell carotid stent implantation. Material and methods: It was a single-arm, prospective study conducted in four experienced catheterisation centres. The use of embolic protection devices was mandatory. The primary endpoint was stroke in 30-day follow-up. The secondary endpoints were 30day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis &lt;= 30%), restenosis rate (%DS &gt;= 50%), and Serious Adverse Device Effect (SADE) rate in 1-year follow-up. Results: In total 100 patients were recruited for the study, with the majority being males (n = 61). The mean age was 68.3 +/- 8.2 years, and most of the patients were asymptomatic (n = 56). In 55 (55%) patients direct stenting was performed, with the use of proximal protection devices in 19 (19%) patients. Mean internal carotid artery/common carotid artery stenosis before and after stent implantation was 81.98 +/- 9.15% and 12.52 +/- 8.70%, respectively (p &lt; 0.001). Procedural success was achieved in all cases. One ischaemic stroke was observed at 30 days (1%, primary endpoint). At 1-year follow-up two myocardial infarctions and three deaths occurred with no additional stroke. Conclusions: The OCEANUS study indicated the safety and efficacy of the MER (TM) stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MERT stents in detail.

Název v anglickém jazyce

Prospective multicentre study of carotid artery stenting using the MER (TM) Stent - the OCEANUS study-30-day and one-year follow-up results

Popis výsledku anglicky

Introduction: Constant technological progress in the field of carotid stenting translates into improved short-and long-term results of endovascular treatment. The introduction of a new generation, self-expanding, open-cell stent has provided a new treatment option in endovascular management of carotid stenosis. Aim: To evaluate 30-day and 1-year clinical outcomes of non-consecutive patients with high risk of carotid endarterectomy, who underwent 5F cylinder-tapered MER (TM) open-cell carotid stent implantation. Material and methods: It was a single-arm, prospective study conducted in four experienced catheterisation centres. The use of embolic protection devices was mandatory. The primary endpoint was stroke in 30-day follow-up. The secondary endpoints were 30day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis &lt;= 30%), restenosis rate (%DS &gt;= 50%), and Serious Adverse Device Effect (SADE) rate in 1-year follow-up. Results: In total 100 patients were recruited for the study, with the majority being males (n = 61). The mean age was 68.3 +/- 8.2 years, and most of the patients were asymptomatic (n = 56). In 55 (55%) patients direct stenting was performed, with the use of proximal protection devices in 19 (19%) patients. Mean internal carotid artery/common carotid artery stenosis before and after stent implantation was 81.98 +/- 9.15% and 12.52 +/- 8.70%, respectively (p &lt; 0.001). Procedural success was achieved in all cases. One ischaemic stroke was observed at 30 days (1%, primary endpoint). At 1-year follow-up two myocardial infarctions and three deaths occurred with no additional stroke. Conclusions: The OCEANUS study indicated the safety and efficacy of the MER (TM) stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MERT stents in detail.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2020

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Advances in Interventional Cardiology / Postępy w Kardiologii Interwencyjnej

ISSN

1734-9338

e-ISSN

—

Svazek periodika

16

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

PL - Polská republika

Počet stran výsledku

9

Strana od-do

1-9

Kód UT WoS článku

000523569800001

EID výsledku v databázi Scopus

2-s2.0-85086014823