EXCELLENT Registry: A Prospective, Multicenter, Global Registry of Endovascular Stroke Treatment With the EMBOTRAP Device.
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Nogueira Raul G, Andersson Tommy, Haussen Diogo C, Yoo Albert J, Hanel Ricardo A, Zaidat Osama O, Hacke Werner, Jovin Tudor G, Fiehler Jens, De Meyer Simon F, Brinjikji Waleed, Doyle Karen M, Kallmes David F, Liebeskind David S, Virmani Renu, Kokoszka Malgosia A, Inoa Violiza, Humphries William, Woodward Keith B, Jabbour Pascal M, François Olivier, Levy Elad I, Bozorgchami Hormozd, Boor Stephan, Cohen Jose E, Dashti Shervin R, Taqi Muhammad A, Budzik Ronald F, Schirmer Clemens M, Hussain M Shazam, Estrade Laurent, De Leacy Reade A, Puri Ajit S, Chitale Rohan V, Brekenfeld Caspar, Siddiqui Adnan H
Аннотация
METHODS: EXCELLENT is a prospective, global registry of patients with acute ischemic stroke treated with EMBOTRAP as the first-line mechanical thrombectomy device conducted at 34 sites (25 sites contributing clot) from September 2018 to March 2021, utilizing core imaging and central histology laboratories blinded to clinical data, independent 90-day modified Rankin Scale assessment and Clinical Events Committee.
RESULTS: After screening 3799 patients, a total of 997 subjects (mean age, 70.0±14.2 years; 51.8% women; 19.7% non-White) were included. The first-pass modified Treatment in Cerebral Infarction (mTICI) ≥2b rate was 64.5% (623/966), first-pass mTICI ≥2c was 39.1% (378/966), and final mTICI ≥2b was 94.5% (931/985). A total of 427/912 (46.8%) patients achieved a 90-day modified Rankin Scale of 0 to 2 or ≤baseline. Embolization to a new territory occurred in 0.2% (2/984), and symptomatic intracranial hemorrhage at 24 hours in 1.6% (16/997). The 90-day mortality was 19.1% (175/918). Device- and/or procedure-related serious adverse events occurred in 5.9% (54/912) through 90 days. The mean RBC percentage of retrieved clots was 45.62±21.372. Among patients who achieved mTICI ≥2b with the first pass, 15.7% (52/331) and 9.7% (32/331), respectively, had RBC-poor (<25%) and RBC-rich (>75%) clots. Patients with no clot retrieved in any procedural pass had a lower percentage of hyperdense or susceptibility vessel sign on baseline imaging (58.9% versus 74.7%; P<0.001), pointing to a potential preprocedure indicator of challenging clot.
CONCLUSIONS: The EXCELLENT registry informs real-world practices in mechanical thrombectomy and sheds light on the range of clots effectively retrieved by current technology. This is the first report of detailed patient characteristics where mechanical thrombectomy maneuvers failed to remove any clot material. Although the composition of nonretrievable clots cannot be assessed histologically, the results support the notion that no retrieval may be correlated with imaging findings suggesting clots lower in RBC.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03685578.