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

• Published in: Postępy w kardiologii interwencyjnej 2020-01, Vol.16 (1), p.1-9
• Main Authors: Pieniążek, Piotr, Nowakowski, Przemysław, Ziaja, Krzysztof, Kobayashi, Adam, Uchto, Wojciech, Sulżenko, Jakub, Machnik, Roman, Tekieli, Łukasz, Stańczyk, Dariusz, Plens, Krzysztof, Zasada, Wojciech, Dziewierz, Artur, Ziaja, Damian
• Format: Article
• Language: English
• Subjects: Cardiology; Carotid arteries; carotid artery stenosis; carotid artery stenting; Heart attacks; Hospitals; Medical imaging; open-cell stent; self-expanding carotid stents; Special Paper; Stents; Stroke; Ultrasonic imaging; Vascular surgery; Veins & arteries
• ISSN: 1734-9338; 1897-4295
• DOI: 10.5114/aic.2019.91364

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. 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. 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. In total 100 patients were recruited for the study, with the majority being males ( = 61). The mean age was 68.3 ±8.2 years, and most of the patients were asymptomatic ( = 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 ( < 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. 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.