Background and purpose With the recent results of clinical trials showing the marked benefit of reperfusion with stent retrievers compared to medical therapy, the Trevo registry is a real world study to assess self-reported reperfusion rates and outcomes. The study was originally planned to enroll 300 patients but has been expanded to 1000 patients.
Methods A total of 1000 patients at a maximum of 75 sites internationally will be enrolled and analyzed. The aim of the study is for to centers to enroll consecutive patients in whom the Trevo device (Trevo ProVue, XP 4 × 20 or XP 3 × 20) was used as the first device to remove a thrombus. Patients were eligible if the device was used in a patient suffering from an ischemic stroke and data was locally adjudicated and submitted to the sponsor for collation and analysis of the data. Data regarding key time points of the processes, reperfusion grade, adverse events and 90 day modified Rankin scores were collected.
Results As of February 9, 2015 a total of 200 patients have been enrolled with a target enrollment of 300 by October 2015. Currently data has been completed on 150 patients with a plan to present data on 225 patients. The mean time from last known normal to arrival to the hospital was 3.7 ± 5.6 h and 64% of patients were treated under 6 h from last known normal and 13% beyond 12 h. The majority of patients were treated for proximal ICA or M1 MCA occlusions (66%) with the rest of the patients being treated for posterior circulation or M2 MCA occlusions. General anesthesia was employed in 69% of procedures and the vast majority of these were for the procedure itself. The mean procedure time was 62 ± 440 min with an average of 1.7 ± 1 pass with the device. The rate of TICI 2B or 3 was 88% and TICI 3 was achieved in 43% of patients. The median NIHSS was reduced from 17 at admission to 8 at 24 h. A total of 33% of patients were discharged to home and 32% to inpatient acute rehab with only 14% of patients being discharged to a nursing home or hospice.
Conclusions The Trevo Retriever Registry represents the first look at the 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. Future subgroup analysis of this large cohort will help to identify areas of future research to enhance outcomes further with this treatment modality.
Disclosures R. Gupta: 1; C; Wellstar Foundation, Stryker Neurovascular, Penumbra, Covidien, Zoll. 2; C; Stryker Neurovascular, Covidien, Rapid Medical, Penumbra. R. Budzik: 2; C; Stryker Neurovascular. B. Xiang: 2; C; Stryker Neurovascular. J. English: 2; C; Stryker Neurovascular. B. Baxter: 2; C; Penumbra, Stryker Neurovascular. S. Ge: 5; C; Stryker Neurovascular. E. Veznedaroglu: 2; C; Stryker Neurovascular.
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