EP46* First pass effect and associated clot characteristics in the EXCELLENT registry – Interim analysis

Journal of NeuroInterventional Surgery(2021)

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Introduction EXCELLENT (NCT03685578) is a prospective, single-arm, multicenter, real-world international registry of mechanical thrombectomy (MT) for stroke with the EmboTrap device as first line treatment. The study entails thrombus analysis of specimens collected with each MT pass. Aim of the Study To compare rates of mRS 0–2 at 90 days and clot characteristics in subjects with and without first pass effect (FPE). Methods FPE was defined as mTICI 2c/3 after one pass and non-FPE as mTICI 2c/3 after >1 pass as adjudicated by an independent core lab. Clot analysis was performed by independent central labs blinded to clinical data. mRS at 90 days was scored by investigators blinded to procedural data. Results Overall mTICI2c/3 rates were 63.7% (326/512). FPE was achieved in 37.1% (190/512) and non-FPE in 26.6% (136/512) subjects. 90 day mRS 0–2 or equal to pre-stroke was achieved in 47.2% (75/159) with FPE and in 42.1% (51/121) non-FPE patients. All-cause 90-day mortality was 19.1% (34/178) in subjects with FPE and 26.4% (34/129) in subjects with non-FPE. Major thrombus components (mean% ±SD) were as follows: RBC: FPE 45.88±20.54, non-FPE 39.08±18.23, and first pass mTICI Conclusions The high rate of ‘real-world’ FPE observed in EXCELLENT was associated with improved clinical outcomes. Clots retrieved with FPE had higher RBC and lower fibrin content compared to non FPE and to first pass mTICI Disclosure EXCELLENT is sponsored by Cerenovus. Dr. Jovin is a consultant for Neuravi, Codman Neurovascular, Stryker (PI DAWN; unpaid), Fundacio Ictus (PI REVASCAT; unpaid), and holds stock in Anaconda, Silk Road, and Blockade Medical.
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