Background The MR CLEAN multicenter randomized clinical trial demonstrated the safety and effectiveness of intra-arterial treatment within 6 h after stroke onset in patients with acute ischemic stroke (AIS) caused by proximal intracranial occlusion in the anterior circulation.
Objective To present the clinical and angiographic outcomes of a MR CLEAN-like population within the real-world multicenter TREVO Stent-Retriever Acute Stroke (TRACK) Post-marketing Registry and assess its performance relative to the MR CLEAN population.
Design/methods The investigator-initiated TRACK Registry recruited sites within North America to submit retrospective data on consecutive patients treated with the TREVO device. A TRACK sub-cohort matched to the MR CLEAN interventional population (based on the following criteria: anterior circulation occlusion, time of onset to groin puncture ≤6 hrs, NIHSS ≥2) was identified (TRACK-MRCL) and compared to the MR CLEAN interventional and control (MRC-I, MRI-C) group of 233 and 267 patients, respectively. The groups were evaluated for differences in the clinical (mRS at 3 months, mortality, and sICH) and angiographic outcomes (TICI revascularization grades).
Results 409 patients underwent treatment using the TREVO device in 18 centers. Of those patients, 250 patients were included in the TRACK-MRCL group. Demographics of the TRACK-MRCL, MRC-I, and MRC-C groups (respectively): median age (IQR) 69 (55–78) versus 65.8 (54.5–76.0), and 65.7 (55.5–76.4); median NIHSS (IQR) 18 (14–22) versus 17 (14–21), and 18 (14–22); male 49.2% vs. 57.9%, and 58.8%, p = 0.12; ICA occlusion 20.4% vs. 25.3%, and 28.2%, p = 0.19; M1 occlusion 59.2% vs. 66.1%, and 62%, p = 0.13; IV-tPA use 67.2% vs. 87.1%, 90.6%, p = 0.0001; general anesthesia use 65.5% vs. 37.5%, p = 0.0001; median time of onset to groin puncture (min) (IQR) 215 (169.8–268.5) versus 260 (210–313). TICI ≥ 2a and TICI ≥ 2b revascularization rates were 92.8% vs. 80.6% (p = 0.0002) and 83.6% vs. 58.7% (p = 0.0001) in the TRACK-MRCL and MRC-I groups, respectively. sICH was noted in 8.5% of TRACK-MRCL patients compared to 7.7% and 6.4% in the MRC-I and
MRC-C groups, respectively (p = 0.87). In TRACK-MRCL patients with available 90-day outcomes, 47.3% (113/239) had achieved a good clinical outcome (mRS 0–2) versus 32.6% (76/233) and 13.1% (35/267) in the MRC-I and MRC-C groups, respectively (p = 0.0014). Mortality was 14.2% (34/239) in the TRACK-MRCL cohort versus 9.0% (21/233) and 8.2% (22/267) in the MRC-I and MRC-C groups, respectively (p = 0.09).
Conclusion Although not directly comparable, this sub-analysis of a real-world TREVO stent-retriever registry patient matched to MR CLEAN population demonstrated consistent higher rates of good clinical and revascularization outcomes than the MR CLEAN control group.
Disclosures A. Castonguay: None. O. Zaidat: 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.
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