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

2018; Lippincott Williams & Wilkins; Volume: 49; Issue: 5 Linguagem: Inglês

10.1161/strokeaha.117.020125

1524-4628

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 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, Nivardo Rodríguez Conde, 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 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, V. 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, Leticia Manuel‐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, T. Seip, R. Balasubramaniam, Jan Gralla, Urs Fischer, Felix Zibold, Eike I. Piechowiak, Reade De Leacy, R. Apruzzeses, Alfonso Castro‐Beiras, 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, Fabienne Marie Soudre, S. Sebastien, M.G. Emmoinoli,

Cerebrovascular and Carotid Artery Diseases

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— Between October 2015 and February 2017, 227 patients were enrolled and treated with the EmboTrap device. The primary efficacy end point (mTICI ≥2b within 3 passes) was achieved in 80.2% (95% confidence interval, 74%–85% versus 56% performance goal criterion; P 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.