Objective Current randomized trials demonstrating superiority of mechanical thrombectomy for the treatment of acute ischemic stroke for anterior circulation large vessel occlusion. These trials included patients up to 6 hours from symptom onset. The Trevo Registry is designed to assess real world outcomes of the Trevo Retriever in patients experiencing acute ischemic stroke within any timeframe. This is the largest prospective study for acute stroke intervention that has currently enrolled 718 (1431 with 90 day outcomes) patients. Enrollment is expected to reach 2000 subjects at up to 100 sites. A subgroup analysis of the number of stent-retriever passes and need for adjuvant devices was studied as a function of time last seen normal as well as etiology of stroke.
Methods The study design is a prospective, open-label, consecutive enrollment, multi-center, global registry of all patients who undergo mechanical thrombectomy for acute stroke using the Trevo stent retriever as the initial device. Subgroup analysis of enrolled patients with 90 day follow-up was performed.
Results As of March, 24, 2017, a total of 1846 patients were enrolled. The median NIHSS at admission was 15.5 (IQR 11–20). Most patients (67.4%) were treated at 6 hours or less from last known normal with a median procedure time of 50 min (8–286 min). Subgroup analysis of patients presenting within 6 hours of symptom onset and those presenting beyond 6 hours showed no significant difference in patient demographics or medical comorbidities. In addition, there was no difference in complication rate or 90 day outcome between the two groups. The time last seen normal to arterial puncture was 0–3 hours in 23.3%, 3–6 hours 44.1%, 6–8 hours 11.3% and >8 hours in 21. 2% of patients. The mean time last known well to arterial puncture was 7.2±22.8 hours. The mean number of passes with any thrombectomy device, including Trevo, was 1.92±1.37 with a range of 1 to 12 passes. The mean number of passes with the Trevo device was 1.68±1.07 with a range of 1 to 10 passes. Adjunctive devices were use at site of thrombus in 23.6% of patients with aspiration catheter being most frequent (8.9%) and typically associated with worse outcomes in multivariate analyses ( OR 0.61 [0.46–0.82, p<0.001). We see slightly more cardo embolic etiology in the <6 hour group (57.5% vs 50.6, p=0.008) We see slightly fewer passes in the <6 vs >6 cohort (1.6 vs 1.8, p=0.02). Despite differences in TLSW, age, or admission NIHSS, an increased number of device passes (>3) was associated with significantly worse recanalization (OR, 0.287 [0.169–0.488], p<0.0001) and worse mRS outcome (OR, 0.335 [0.206–0.547], p<0.0001).
Conclusions The Trevo Retriever Registry represents the first look at real world data with stent retriever use in the era of clinical trials showing the overwhelming benefit of stent retrievers to treat acute ischemic stroke. This data represents real world use of the Trevo Retriever in regards to the typical number of passes and devices required for recanalization.
Disclosures M. Binning: None. E. Veznedaroglu: 2; C; stryker. B. Baxter: None. J. English: None. R. Budzik: None. B. Bartolini: None. D. Liebeskind: None. A. Krajina: None. R. Gupta: None. R. Nogueira: None.