Abstract

JACC

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TCTAP A-034

OCEANUS (PrOspective multiCentEr study of cArotid artery steNting Using mer Stent) Study – 30-Day and Five -Year Results

By Przemek Nowakowski, Piotr Odrowaz-Pieniazek

Presenter

Przemek Nowakowski

Authors

Przemek Nowakowski1, Piotr Odrowaz-Pieniazek2

Affiliation

University of Technology, Katowice, Poland1, John Paul II Hospital, Jagiellonian University, Poland2
View Study Report
TCTAP A-034
Carotid & Neurovascular Intervention

OCEANUS (PrOspective multiCentEr study of cArotid artery steNting Using mer Stent) Study – 30-Day and Five -Year Results

Przemek Nowakowski1, Piotr Odrowaz-Pieniazek2

University of Technology, Katowice, Poland1, John Paul II Hospital, Jagiellonian University, Poland2

Background

BackgroundObjective: Technological progress in devices dedicated for carotid artery stenting and hence endovascular interventions brings about continued improvement of treatment results. Introduction of new generation self-expanding, open-cell stents may take this improvement even further. We report 30-day and 5-year clinical outcomes of carotid artery stenting using a new open-cell MER stent in a cohort at higher risk for carotid endarterectomy. The study was registered at ClinicalTrials.gov (NCT03133429). 
 

Methods

Material and Methods: This was a single arm, prospective study involving four high-volume endovascular treatment centres in Poland. One hundred patients entered the study (61 men and 39 women). The mean age was 68.3 +/-8.2; fifty-six patients were asymptomatic. The study protocol required the use of embolic protection devices. The primary endpoint was a stroke within a 30-day follow-up. The secondary endpoints were the 30-day, 1-year and 5-year cumulative incidence of death, stroke and myocardial infarction, 1- and 5-year target vessel revascularization, procedural success (residual stenosis ≤30%), restenosis rate (%DS ≥50%) and Serious Adverse Device Effect (SADE).

Results

Procedure and Results: Predilatation was performed in 45 patients (45%) and distal and proximal protection was used in 81% and 19% respectively. The mean internal carotid artery stenosis rated in QCA before and after stent implantation was 81.98+/-9.15% and 12.52+/-8.70%, respectively (p<0.001. Procedural success rate was 100%. Two ischemic stroke (2%)in symptomatic group was observed (within 30 days and in 4-th year of follow-up). 3% TVR rate was reported (1% in Sx group).Three myocardial infarctions and therteen deaths were reported within five years of the intervention.

Conclusion

Conclusions: the OCEANUS study results confirmed the safety and efficacy of MER stent during 30-day and 5-year follow-ups, both in symptomatic and asymptomatic patients. A further cohort study is planned to assess long-term results.

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