Objective: The Trevo Registry is designed to assess real world outcomes of the Trevo Retriever in patients experiencing ischemic stroke. This is the largest prospective study for acute stroke intervention, with 1247 patients currently enrolled and 90 day outcomes in 1021 patients. The primary endpoint is revascularization status based on post-procedure TICI score and secondary endpoints include 90-day mRS, 90-day mortality, neurological deterioration at 24 hours and device/procedure related adverse events.
Methods: The study is a prospective, open-label, consecutive enrollment, multi-center, international registry of patients undergoing mechanical thrombectomy for acute stroke using the Trevo stent retriever as the initial device. Enrollment is expected to reach 2000 subjects at up to 100 sites.
Results: As of August 13, 2016 a total of 1247 patients were enrolled. The median NIHSS at admission was 16 (IQR 11-20). Most patients (66.2%) were treated at >/= 6 hours from last known normal with a median procedure time of 50 minutes (32-77). The occlusion site was M1 or M2 in 74.5%. General anesthesia was employed in 46.6% of procedures. TICI 2b or 3 revascularization was 92.8% with an average of 1.6 passes with the device. Median NIHSS at 24 hours and discharge was 6 and 4 respectively. Fifty-five percent of patients had mRS ≤2 at 3 months and the overall mortality rate was 15.4%. Patients treated after 8 hours of symptom onset had a 94.9% revascularization rate and 52.8% mRS ≤2 at 3 months. The symptomatic ICH rate was 1.2%. Patients who met the revised AHA criteria for thrombectomy were found to have 58.4% mRS 0-2 at 90 days.
Conclusions: The Trevo Retriever Registry represents the first 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. Due to the fact that this data represents real world use of the Trevo Retriever, (e.g. subjects pre-stroke mRS >1 (16.5%) and those treated 6-24 hours after stroke symptoms (33.8%), this data cannot be compared to the results from recent trials with restricted eligibility criteria. Future subgroup analysis of this large cohort will help to identify areas of future research to enhance outcomes further with this treatment modality.