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

Piotr Pieniążek; Przemysław Nowakowski; Krzysztof Ziaja; Adam Kobayashi; Wojciech Uchto; Jakub Sulżenko; Roman Machnik; Lukasz Tekieli; Dariusz Stańczyk; Krzysztof Plens; Wojciech Zasada; Artur Dziewierz; Damian Ziaja

doi:10.5114/aic.2019.91364

eISSN: 1897-4295
ISSN: 1734-9338

Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej

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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

Department of Vascular Surgery Division on Endovascular Therapy, John Paul II Hospital, Krakow, Poland
Department of Cardiac and Vascular Disease, Institute of Cardiology, Jagiellonian University, School of Medicine, Krakow, Poland
Department of Vascular Surgery, American Heart of Poland, Chrzanow, Poland
University of Technology, Katowice, Poland
Department of General and Vascular Surgery, Angiology, and Phlebology, Medical University of Silesia, Katowice, Poland
Institute of Psychiatry and Neurology, 2nd Department of Neurology, Warsaw, Poland
Cardiocentre, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University Prague, Czech Republic
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University, Medical College, Krakow, Poland
KCRI, Krakow, Poland
2nd Department of Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Department of Physiotherapy, School of Health Science in Katowice, Medical University of Silesia, Katowice, Poland

Adv Interv Cardiol 2020; 16, 1 (59): 1–9

DOI: https://doi.org/10.5114/aic.2019.91364

Online publish date: 2019/12/31

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AMA

Pieniążek P, Nowakowski P, Ziaja K, et al. Prospective multicentre study of carotid artery stenting using the MER™ Stent – the OCEANUS study – 30-day and one-year follow-up results. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2020;16(1):1-9. doi:10.5114/aic.2019.91364.

APA

Pieniążek, P., Nowakowski, P., Ziaja, K., Kobayashi, A., Uchto, W.,  & Sulżenko, J. et al. (2020). Prospective multicentre study of carotid artery stenting using the MER™ Stent – the OCEANUS study – 30-day and one-year follow-up results. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 16(1), 1-9. https://doi.org/10.5114/aic.2019.91364

Chicago

Pieniążek, Piotr, Przemysław Nowakowski, Krzysztof Ziaja, Adam Kobayashi, Wojciech Uchto, Jakub Sulżenko,  and Roman Machnik et al. 2020. "Prospective multicentre study of carotid artery stenting using the MER™ Stent – the OCEANUS study – 30-day and one-year follow-up results". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 16 (1): 1-9. doi:10.5114/aic.2019.91364.

Harvard

Pieniążek, P., Nowakowski, P., Ziaja, K., Kobayashi, A., Uchto, W., Sulżenko, J., Machnik, R., Tekieli, L., Stańczyk, D., Plens, K., Zasada, W., Dziewierz, A.,  and Ziaja, D. (2020). Prospective multicentre study of carotid artery stenting using the MER™ Stent – the OCEANUS study – 30-day and one-year follow-up results. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 16(1), pp.1-9. https://doi.org/10.5114/aic.2019.91364

MLA

Pieniążek, Piotr et al. "Prospective multicentre study of carotid artery stenting using the MER™ Stent – the OCEANUS study – 30-day and one-year follow-up results." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 16, no. 1, 2020, pp. 1-9. doi:10.5114/aic.2019.91364.

Vancouver

Pieniążek P, Nowakowski P, Ziaja K, Kobayashi A, Uchto W, Sulżenko J et al. Prospective multicentre study of carotid artery stenting using the MER™ Stent – the OCEANUS study – 30-day and one-year follow-up results. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2020;16(1):1-9. doi:10.5114/aic.2019.91364.

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:

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

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