Background Real life practice can differ significantly from criteria in randomized clinical trials (RCT), including patient population, treatment criteria, and broader treatment times. Distinguishing device performance in these two different scenarios is critical in applying RCT data to routine clinical practice.
Objective The TREVO Stent-Retriever Acute Stroke (TRACK) Registry aimed to assess the real-world safety, angiographic, and clinical efficacy of the TREVO device in comparison to the results from the TREVO-2 clinical trial.
Design/methods The TRACK Registry recruited clinical sites within the USA. Demographic, clinical, angiographic, and outcome data on patients treated with the TREVO device were collected. Symptomatic intracranial hemorrhage (sICH) was defined as any parenchymal hematoma, SAH, or IVH associated with a worsening of the NIHSS score by≥4 within 24 h. The primary outcome was achieving TICI≥2a revascularization. Secondary outcomes were mRS at 3 months, mortality, and sICH.
Results 23 centers contributed data on 586 patients for the final analysis. Baseline demographics were: 48.6% female, 68.3% white, mean age 65.8 ± 14.9 years, median baseline NIHSS of 17 (IQR 13–22), M1 (54.2%)/ICA(17.1%)/VB(13.7%) occlusion, IV-tPA use 50.4%, general anesthesia 63.2%, balloon guide catheter use 47.0%, mean fluoroscopic time 26.2 ± 22.1 min, and a median revascularization time of 65.5 (IQR 37–105.75) minutes.
The TICI ≥2a and TICI ≥2b revascularization rates were 92.4% (537/581) and 80.4% (467/581), compared to the operator reported TICI ≥ 2a rate of 85% and core laboratory adjudicated TICI ≥2b of 68% in TREVO-2. Good outcome (mRS≤2) was demonstrated in 48.3% (240/497), compared to 40% (TREVO-2). The rate of sICH was 7.5% (43/574), compared to 4% (TREVO-2). 90-day mortality was 20.1% (100/497) versus 29% in TREVO-2.
Multivariate logistic regression analysis demonstrated that younger patients, lower baseline NIHSS, revascularization success (TICI ≥2B), and use of conscious sedation were independent predictors of good clinical outcome. Independent predicators of mortality included older patients, higher baseline NIHSS, vertebral-basilar occlusion, lack of IV-tPA use, failure to achieve revascularization, and sICH.
Conclusion The investigator-initiated TRACK Registry demonstrates that the post-marketing TREVO stent-retriever performance in routine clinical practice is comparable to the TREVO-2 trial, with improved revascularization success, good outcome, and decreased mortality.
Disclosures O. Zaidat: 1; C; Stryker, Covidien. 2; C; Stryker, Covidien. A. Castonguay: None. R. Nogueira: None. P. Ramakrishnan: None. D. Haussen: None. A. Lima: None. J. English: None. H. Farid: None. E. Veznedaroglu: None. M. Binning: None. A. Puri: None. S. Hou: None. V. Janardhan: None. N. Vora: None. R. Budzik: None. A. Alshekhlee: None. M. Abraham: None. R. Edgell: None. M. Taqi: None. E. Lin: None. R. Khoury: None. M. Mokin: None. A. Majjhoo: None. M. Kabbani: None. M. Froehler: None. I. Finch: None. S. Prabhakaran: None. R. Novakovic: None. T. Nguyen: None. J. Wesley: None.
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