Article Text
Abstract
Introduction/Purpose Rapid reperfusion is associated with the best clinical outcomes following thrombectomy. Multiple first pass effect (FPE) definitions exist based on the extent of reperfusion, with previous work showing that first pass eTICI (expanded Treatment in Cerebral Ischemia) 2c-3 is the optimal discriminator of good outcome. Emerging data suggest an equally beneficial effect of eTICI 2b67 compared to eTICI 2c. Using data from the CLEAR study of the NeVa device, we sought to compare outcomes following eTICI 2b67 reperfusion to determine whether it should be included into the optimal FPE definition.
Materials and Methods A secondary analysis of the prospective, multicenter, FDA-regulated CLEAR trial was conducted on the Intention to Treat (ITT) study population of 139 patients. An independent core lab prospectively adjudicated eTICI including the 2b67 threshold during the trial. Good outcome (90-day mRS 0-2) rates were compared between individual eTICI score levels at procedure end (final eTICI). The association between the number of passes to achieve eTICI 2b67 or greater and the likelihood of a good clinical outcome at 90 days (mRS 0-2) was assessed with logistic regression. Significance was taken at P<0.05.
Results The proportion of final eTICI scores were 2a in 2 patients (1.4%), 2b50 in 11 (7.9%), 2b67 in 20 (14.4%), 2c in 45 (32.4%), and 3 in 61 (43.9%). Good outcomes were seen in none of the final 2a patients, 45.5% (5/11) of 2b50, 60% (12/20) of 2b67, 59.1% (26/44) of 2c, and 72.1% (44/61) of 3 (P=0.02, Cochran-Armitage trend test) (see figure). First pass eTICI 2b67-3 was seen in 64.0% (89/139). Good outcome rate was 73.0% (65/89) with FP 2b67-3 versus 44.9% (22/49) without (P=0.001, Chi-squared). For the 125 subjects that achieved an eTICI score of 2b67-3, the odds of a good outcome decreased by a multiple of 0.545 for each additional pass completed (p-value = 0.005).
Conclusion Core lab-adjudicated data from CLEAR reveal equivalent rates of good outcome between final eTICI 2b67 and final eTICI 2c reperfusion, supporting eTICI 2b67-3 as an optimal benchmark of treatment success. NeVa results in eTICI 2b67-3 in almost two-thirds of patients after a single pass.
Disclosures A. Yoo: 1; C; Medtronic, Cerenovus, Penumbra, Stryker, Genentech. 2; C; Vesalio, Cerenovus, Penumbra, Zoll Circulation, Philips Neurovascular. 4; C; Insera Therapeutics, Nicolab. S. Geyik: 2; C; Stryker, Microvention, Medtronic. M. Froehler: 1; C; Genentech, Vesalio, Siemens. 2; C; Cerenovus, Balt, Jacobs Institute, Kai Medical, Oculus. C. Maurer: None. T. Kass-Hout: None. O. Zaidat: None. R. Nogueira: 1; C; Cereous, Viz-AI, Qu’Appelle Medical, Turvi, Vastrad, Vision. 2; C; Anaconda, Biogen, Cereous, Genentech, Philips, Hibernia, Imperative Care, Medtronic, Phenox, Philips, Prolong Pharmaceuticals, Stryker Neurovascular, Shanghai Wallaby, Synchrony. 4; C; Astrocyte, Brain mix, Cerebrates, Retrieve, Corinda’s Vascular Robotics, Vesalio, Viz-AI, Rapid Pulse, Perfuse. R. Hanel: 2; C; Vesalio, Rapid Medical, Medtronic, Stryker, Cerenovous, Balt, Phenox, Elum, MIVI. 4; C; ThromX,, Cerebrotech, Endostream, RIST, REIST, Serenity, BendIT. L. Pierot: None. L. Spelle: 1; C; Philips. 2; C; Balt, Medtronic, Microvention, Stryker. D. Lopes: None. A. Hassan: 2; C; Medtronic, Microvention, Cerenovus, Stryker, Penumbra, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care. Š. Audrius: 2; C; Microvention, Vesalio, Stryker. E. Lin: None. M. Ribó: None. J. Blasco: None. M. Taqi: None. A. Badruddin: None. A. Siddiqui: 1; C; NIH - 1R01EB030092-01. 2; C; Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200 LLC, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Inc.. 4; C; Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd., BlinkTBI, Inc., Borvo Medical, Inc., Cerebrotech Medical Systems, Inc., Cerevatech Medical, Inc., Cognition Medical, Collavidence. 6; C; Brain Aneurysm Foundation Carol W. Harvey Chair of Research. T. Miller: 2; C; CARPL.ai. S. Hussain: 1; C; Medtronic Neurovascular, Stryker Neurovascular, Rapid Medical. 2; C; Cerenovus. D. Haussen: 2; C; Cerenovus, Stryker Neurovascular, Chiesi USA, Brainomix, Poseydon Medical. 4; C; VizAI and Motif. 6; C; Jacobs Institute/Medtronic, Vesalio, Frontiers in Neurology. K. Woodward: 2; C; Cerenovus, Medtronic, Microvention, Penumbra, Stryker. C. Groden: None. A. Consoli: None. I. Chaudry: 2; C; Celt/Vasorum, Microvention, Medtronic, Imperative Care, Q’Apel. 4; C; Imperative Care, Celt/Vasorum, Synchron, Endostream, Cerebrotech, Q’Apel, RIST, Three Rivers Medical, Neuolutions, Radical Medical, Tulavi, viseon, VMT, Vastrax, Serenity Medical. C. Ramsey: None. A. Maud: None. J. Bentley: None. W. Brinjikji: None. A. Bajrami: None. M. Sahnoun: 2; C; Vesalio. J. Fiehler: None. R. Gupta: 1; C; Vesalio, Rapid Medical, Cerenovous, Medtronic, Stryker, Zoll.