Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap)

Authors: Osama O. Zaidat, Hormozd Bozorgchami, Marc Ribó, Jeffrey L. Saver, Heinrich P. Mattle, René Chapot, Ana Paula Narata, Olivier François, Ashutosh P. Jadhav, Jonathan A Grossberg, Christian Heiner Riedel, Alejandro Tomasello, Wayne M. Clark, Hannes Nordmeyer, Eugene Lin, Raul G. Nogueira, Albert J. Yoo, Tudor G. Jovin, Adnan H. Siddiqui, Thierry Bernard, Mairsíl Claffey, Tommy Andersson, Marc Ribó, Steven W. Hetts, Werner Hacke, Brijesh Mehta, Lotfi Hacein‐Bey, A. Kim, Alex Abou‐Chebl, Peter Shabe, Steven W. Hetts, Lotfi Hacein‐Bey, A. Kim, Alex Abou‐Chebl, J. Dix, Joan Gurian, Wolfgang Zink, Guilherme Dabus, Neil O’Leary, Anne F. Reilly, K. Lee, J. A. Foley, Matthew J. Dolan, E. Hartley, Tamara D. Clark, Kari C. Nadeau, Joseph M. Shama, M. Louise Hull, Benjamin L. Brown, Ryan Priest, Gary M. Nesbit, Masahiro Horikawa, D. Hoak, Barbara A. Petersen, Noah Beadell, Kory Herrick, Christopher J. White, Michael Stacey, S. Ford, Jesse Liu, Marc Ribó, Estela Sanjuán, Mireia Sanchis, C. Marín Molina, David Rodríguez‐Luna, Sandra Boned Riera, J Pagola, Marta Rubiera, Jesús Juega, N. Rodríguez, Nicole Müller, Michael C. Stauder, Paul Stracke, Markus Heddier, Vladimir Charron, Aliette Decock, Denis Herbreteau, Richard Bibi, A.S. De Sloovere, I. Doutreloigne, Denis Pieters, Tom Dewaele, P. Bourgeois, F. Vanhee, P. Vanderdouckt, E. Vancaster, Lisa Baxendell, Valerie Gilchrist, Y. Cannon, Caran Graves, K. Armbruster, Tudor G. Jovin, Brian T. Jankowitz, Andrew F. Ducruet, Amin Aghaebrahim, Cynthia L. Kenmuir, Hazem Shoirah, Bradley J. Molyneaux, P. Tadi, Gregory Walker, Mark D. Starr, Shannon Doppelheuer, Kaspar Schindler, Lynette L. Craft, M. Schultz, Héctor Pérez, J. Park, Alex Hall, A. Mitchell, Laura E. Webb, Diogo C Haussen, Michael Frankel, Nicolas Bianchi, Samir Belagaje, N. Mahdi, Sourabh Lahoti, Anna Katema, Maryl L. Winningham, A. Anderson, Denise Tilley, T. Steinhauser, David A. Scott, A.A. Thacker, Virginie Calderon, Eugene Lin, S. Becke, S Krieter, Olav Jansen, Fritz Wodarg, Naomi Larsen, Andreas Binder, Chris Wiesen, Mary L. Hartney, L. Bookhagan, Heather J. Ross, J. Gay, Kenneth V. Snyder, Elad I. Levy, Jason M. Davies, Ashish Sonig, Leonardo Rangel-Castilla, Ashkan Mowla, Hakeem J Shakir, Victoria Fennell, G. Atwal, Shobha Natarajan, Jeffrey S. Beecher, John Thornton, Alexis E. Cullen, Paul Brennan, Alan O’Hare, Hamed Asadi, R Budzik, Matthew Taylor, Maria Rain Jennings, F. Laube, J. Brooks Jackson, R. Gatrell, Laura Reebel, A. Albon, J. Gerniak, Katherine M. Groezinger, Meghan Lauf, N. Voraco, Peter Pema, Tom Davis, William J. Hicks, J Mejilla, Mohamed Teleb, Peter Sunenshine, Elizabeth Russo, Robert Flynn, J. Twyford, Anna Ver Hage, Smith Ee, L. Apolinar, Sarah Ganz Blythe, J. Maxan, Jonathan Carter, T. Taschner, Ulrike Bergmann, Stephan Meckel, Somaia Elsheik, Horst Urbach, Christoph J. Maurer, Karl Egger, Wolf‐Dirk Niesen, B Baxter, A. Knox, Bill Hazelwood, Steven Quarfordt, John W. Calvert, H. Hawk, R.S. Malek, Arash Padidar, Ursula Tolley, Ángela Gutiérrez, Pasquale Mordasini, Tomas Seip, R. Balasubramaniam, Jan Gralla, Urs Fischer, Felix Zibold, Eike I. Piechowiak, R. DeLeacy, R. Apruzzeses, C. Alfonso, J.W. Haslett, Johanna T Fifi, J Mocco, Sidney Starkman, J Guzy, Neil E. Grunberg, Viktor Szeder, Satoshi Tateshima, Gary Duckwiler, May Nour, David S. Liebeskind, Xiangqi Tang, J. Hinman, Aaryani Tipirneni‐Sajja, Dileep R. Yavagal, Luis Guada, Karen Bates, S. Balladeras, Satheesh K Bokka, S. Suir, Jason P. Caplan, P. Kandewall, Eric D. Peterson, Robert M. Starke, Ajit S Puri, Michael A. Hawk, C Brooks, J. L’Heurex, K. Ty, D Rex, Francesco Massari, Ajay K. Wakhloo, Diego Lozano, K.D. Rodrigua, Laurent Pierot, M. Fabienne, S. Sebastien, M.G. Emmoinoli - Stroke 2018 cited by 149

BACKGROUND AND PURPOSE: EmboTrap is a novel stent retriever designed to achieve rapid and substantial flow restoration in acute ischemic stroke secondary to large-vessel occlusions. Here, we evaluated EmboTrap's safety and efficacy compared with established stent retrievers. METHODS: ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) was a single-arm, prospective, multicenter study, comparing the EmboTrap device to a composite performance goal criterion derived using a Bayesian meta-analysis from the pivotal SWIFT (Solitaire device) and TREVO 2 (Trevo device) trials. Patients at 11 US and 8 European sites were eligible for inclusion if they had large-vessel occlusions and moderate-to-severe neurological deficits within 8 hours of symptom onset. The primary efficacy end point was achievement of modified Thrombolysis in Cerebral Ischemia (mTICI) reperfusion scores of ≥2b within 3 EmboTrap passes as adjudicated by the core laboratory. The primary safety end point was a composite of symptomatic intracerebral hemorrhage and serious adverse device effects. Secondary end points included functional independence (modified Rankin Scale, 0-2) and all-cause mortality at 90 days. RESULTS: value, <0.0001), and mTICI 2c/3 was 65%. After all interventions, mTICI 2c/3 was achieved in 76%, and mTICI ≥2b was 92.5%. The rate of first pass (mTICI ≥2b following a single pass) was 51.5%. The primary safety end point composite rate of symptomatic intracerebral hemorrhage or serious adverse device effects was 5.3%. Functional independence and all-cause mortality at 90 days were 67% and 9%, respectively. CONCLUSIONS: The EmboTrap stent-retriever mechanical thrombectomy device demonstrated high rates of substantial reperfusion and functional independence in patients with acute ischemic stroke secondary to large-vessel occlusions. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02488915.