Background Recent randomized clinical trials (RCTs) demonstrated the efficacy of mechanical thrombectomy using stent-retrievers in patients with acute ischemic stroke (AIS) with large vessel occlusions; however, it remains unclear if these results translate to a real-world setting. The TREVO Stent-Retriever Acute Stroke (TRACK) multicenter Registry aimed to evaluate the use of the Trevo device in everyday clinical practice.
Methods Twenty-three centers enrolled consecutive AIS patients treated from March 2013 through August 2015 with the Trevo device. The primary outcome was deﬁned as achieving a Thrombolysis in Cerebral Infarction (TICI) score of ≥2b. Secondary outcomes included 90-day modified Rankin Scale (mRS), mortality, and symptomatic intracranial hemorrhage (sICH).
Results A total of 634patients were included. Mean age was 66.1±14.8 years and mean baseline NIH Stroke Scale (NIHSS) score was 17.4±6.7; 86.7% had an anterior circulation occlusion. Mean time from symptom onset to puncture and time to revascularization were 363.1±264.5 min and 78.8±49.6 min, respectively. 80.3% achieved TICI ≥2b. 90-day mRS ≤2 was achieved in 47.9%, compared with 51.4% when restricting the analysis to the anterior circulation and within 6 hours (similar to recent AHA/ASA guidelines), and 54.3% for those who achieved complete revascularization. The 90-day mortality rate was 19.8%. Independent predictors of clinical outcome included age, baseline NIHSS, use of balloon guide catheter, revascularization, and sICH.
Conclusion The TRACK Registry results demonstrate the generalizability of the recent thrombectomy RCTs in real-world clinical practice. No differences in clinical and angiographic outcomes were shown between patients treated within the AHA/ASA guidelines and those treated outside the recommendations.
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Contributors All authors participated in the design, conception, data gathering, writing, meaningful editing, suggestions, and feedback on the final manuscript.
Funding Stryker Neurovascular; limited coordinating center administrative grant. No per patient cost was provided.
Competing interests IL is consultant for Metronic, Stryker, Penumbra, and Cordis. MM is consultant for Claret Medical, Nogueira-Stryker Neurovascular (Trevo-2 Trial Principal Investigator – modest; DAWN Trial Principal Investigator – no compensation, TREVO Registry Steering Committee – no compensation), Medtronic (SWIFT Trial Steering Committee – modest; SWIFT-Prime Trial Steering Committee – no compensation; STAR Trial Angiographic Core Lab – significant), Penumbra (3D Separator Trial Executive Committee – no compensation), Neuravi (ARISE-2 Steering Committee – no compensation), Genentech (Physician Advisory Board – modest), Allm Inc (Physician Advisory Board – no compensation), Editor-In-Chief Interventional Neurology Journal (no compensation). SRS is a consultant for Stryker Neurovascular. OOZ is overall PI for TRACK – no compensation, Arise II – modest, Co-PI Therapy Trial – modest, Steering committee STRATIS registry – modest.
Ethics approval Ethics approval was provided by Mercy Health St. Vincent Hospital institutional review board and the ethics committee at each participating institution.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement There are no additional unpublished data from this particular study comparing the post marketing experience of the TREVO device with the industry sponsored prospective study. Additional questions are being addressed by other sub-papers currently under development.
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