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

Abstract

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.