eISSN: 1897-4295
ISSN: 1734-9338
Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej
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SCImago Journal & Country Rank
1/2020
vol. 16
 
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abstract:
Special paper

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

Piotr Pieniążek
1, 2
,
Przemysław Nowakowski
3, 4
,
Krzysztof Ziaja
5
,
Adam Kobayashi
6
,
Wojciech Uchto
3
,
Jakub Sulżenko
7
,
Roman Machnik
1
,
Lukasz Tekieli
1, 8
,
Dariusz Stańczyk
5
,
Krzysztof Plens
9
,
Wojciech Zasada
9
,
Artur Dziewierz
10
,
Damian Ziaja
11

1.
Department of Vascular Surgery Division on Endovascular Therapy, John Paul II Hospital, Krakow, Poland
2.
Department of Cardiac and Vascular Disease, Institute of Cardiology, Jagiellonian University, School of Medicine, Krakow, Poland
3.
Department of Vascular Surgery, American Heart of Poland, Chrzanow, Poland
4.
University of Technology, Katowice, Poland
5.
Department of General and Vascular Surgery, Angiology, and Phlebology, Medical University of Silesia, Katowice, Poland
6.
Institute of Psychiatry and Neurology, 2nd Department of Neurology, Warsaw, Poland
7.
Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University Prague, Czech Republic
8.
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University, Medical College, Krakow, Poland
9.
KCRI, Krakow, Poland
10.
2nd Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland
11.
Department of Physiotherapy, School of Health Science in Katowice, Medical University of Silesia, Katowice, Poland
Adv Interv Cardiol 2020; 16, 1 (59): 1–9
Online publish date: 2019/12/31
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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™ 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 30-day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis ≤ 30%), restenosis rate (%DS ≥ 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 < 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™ 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 MER™ stents in detail.

keywords:

carotid artery stenosis, carotid artery stenting, self-expanding carotid stents, open-cell stent

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