Prospective multicentre study of carotid artery stenting using the MER (TM) 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 (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 = 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 (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.