Five-year results of the SCENT trial with Surpass flow diverters to treat large or giant wide-neck aneurysms.

Abstract

Background: One-year and 3-year outcomes for the SCENT trial have previously been reported. However, 5-year (long-term) clinical outcomes have not previously been described.

Methods: In this multicenter prospective trial, 180 aneurysms in 180 subjects were treated with the Surpass flow diverter system across 26 sites. Patients were followed according to a standardized protocol at 1 month, 6 months, 1 year, 3 years, and 5 years. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale (mRS) scores, and complications were recorded.

Results: The 5-year clinical follow-up reported 119 subjects and nine deaths with a completion rate of 71.1%, with 5-year angiographic follow-up available in 82 of the surviving 171 patients (48%). Aneurysm occlusion (Raymond Class I) for those patients who underwent angiographic follow-up was 77.8% (91/117) and 90.2% (74/82) at 3 and 5 years. The primary effectiveness composite endpoint was achieved in 80.3% (57/71) of patients. The cumulative proportion of subjects experiencing new or worsening major ipsilateral stroke was 12.8% (23/180) at 36 months, with no new occurrences at 60 months. No late aneurysm ruptures occurred during the 5-year follow-up, and no additional retreatments occurred between 36 and 60 months. Between 3 and 5 years, 52 potential site-reported serious adverse events were sent to CEC for adjudication. Of these, nine were CEC-adjudicated to be serious and four were determined to be related to the procedure/device.

Conclusions: Five-year findings demonstrate the long-term safety and effectiveness of the Surpass flow diverter for intracranial aneurysm treatment, supported by high occlusion rates and low rates of delayed adverse events in this study.

Trial registration number: NCT01716117.