One-year efficacy and safety of the Trufill DCS Orbit and Orbit Galaxy detachable coils in the endovascular treatment of intracranial aneurysms: Results from the TRULINE study. - Archive ouverte HAL Access content directly
Journal Articles Interventional Neuroradiology Year : 2017

One-year efficacy and safety of the Trufill DCS Orbit and Orbit Galaxy detachable coils in the endovascular treatment of intracranial aneurysms: Results from the TRULINE study.

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Raphael Blanc
Hubert Desal

Abstract

Background and purpose No series reported the mid-term results of Trufill DCS Orbit and Orbit Galaxy detachable coils with independent evaluation. We present the one-year safety and efficacy of these coils in real-life routine clinical practice. Methods A total of 167 patients with 167 aneurysms (39.1% ruptured) were enrolled in the prospective TRULINE study. The primary endpoint was the safety, assessed by the combined morbidity-mortality rate observed since the time of the procedure and up to one-year follow-up. For safety, primary analyses were performed on intent-to-treat population (attempted coils procedure) and all adverse events have been reviewed by an independent Data Safety Monitoring Board. For efficacy, primary analyses were performed on the per-protocol population (patients treated with more than 70% of Trufill coils and not retreated during the follow-up period) and an independent core laboratory evaluated angiographic results. Results At one-year post-procedure, neurologic impairment was observed in 6.5% (95% confidence interval: 3.5-11.8) of the patients, and 2.6% (95% confidence interval: 1.0-6.8) had a permanent neurological deterioration. Three deaths were observed, unrelated to the procedure or coils. At one year, complete occlusion was seen in 52 aneurysms (54.2%), neck remnant in 28 aneurysms (29.2%), and aneurysm remnant in 16 aneurysms (16.7%). During the one-year follow-up, the overall incidence of recurrence was 30.2% with a mean interval of 13.8 ± 4.5 months and the retreatment for major recanalization was needed in nine patients (6.3%). Conclusions The TRULINE study confirms that endovascular coiling with Trufill DCS Orbit and Orbit Galaxy detachable coils is safe and effective.

Dates and versions

hal-01576317 , version 1 (22-08-2017)

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Benjamin Gory, Laure Huot, Roberto Riva, Paul Labeyrie, Olivier Levrier, et al.. One-year efficacy and safety of the Trufill DCS Orbit and Orbit Galaxy detachable coils in the endovascular treatment of intracranial aneurysms: Results from the TRULINE study.. Interventional Neuroradiology, 2017, ⟨10.1177/1591019917717576⟩. ⟨hal-01576317⟩
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