Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Issue 5 (May 2018)

• Record Type: Journal Article
• Authors: Zaidat, Osama O.; Bozorgchami, Hormozd; Ribó, Marc; Saver, Jeffrey L.; Mattle, Heinrich P.; Chapot, René; Narata, Ana Paula; Francois, Olivier; Jadhav, Ashutosh P.; Grossberg, Jonathan A.; Riedel, Christian H.; Tomasello, Alejandro; Clark, Wayne M.; Nordmeyer, Hannes; Lin, Eugene; Nogueira, Raul G.; Yoo, Albert J.; Jovin, Tudor G.; Siddiqui, Adnan H.; Bernard, Thierry; Claffey, Mairsíl; Andersson, Tommy; Ribo, M.; Hetts, S.; Hacke, W.; Mehta, Brijesh; Hacein-Bey, L.; Kim, A.; Abou-Chebl, A.; Shabe, P.; Hetts, S.; Hacein-Bey, L.; Kim, A.; Abou-Chebl, A.; Dix, J.; Gurian, J.; Zink, W.E.; Dabus, G.; O'Leary,, N.; Reilly, A.; Lee, K.; Foley, J.; Dolan, M.; Hartley, E.; Clark, T.; Nadeau, K.; Shama, J.; Hull, L.; Brown, B.; Priest, R.; Nesbit, G.; Horikawa, M.; Hoak, D.; Petersen, B.; Beadell, Noah; Herrick, Kory; White, C.; Stacey, M.; Ford, S.; Liu, J.; Ribó, M.; Sanjuan,, E.; Sanchis, M.; Molina, C.; Rodríguez-Luna,, D.; Boned Riera, S.; Pagola, J.; Rubiera, M.; Juega, J.; Rodríguez, N.; Muller, N.; Stauder, M.; Stracke, P.; Heddier, M.; Charron, V.; Decock, A.; Herbreteau, D.; Bibi, R.; De Sloovere, A.S.; Doutreloigne, I.; Pieters, D.; Dewaele, T.; Bourgeois, P.; Vanhee, F.; Vanderdouckt, P.; Vancaster, E.; Baxendell, L.; Gilchrist, V.; Cannon, Y.; Graves, C.; Armbruster, K.; Jovin, T.; Jankowitz, B.; Ducruet, A.; Aghaebrahim, A.; Kenmuir, C.; Shoirah, H.; Molyneaux, B.; Tadi, P.; Walker, G.; Starr, M.; Doppelheuer, S.; Schindler, K.; Craft, L.; Schultz, M.; Perez, H.; Park, J.; Hall, A.; Mitchell, A.; Webb, L.; Haussen, D.; Frankel, M.; Bianchi, N.; Belagaje, S.; Mahdi, N.; Lahoti, S.; Katema, A.; Winningham, M.; Anderson, A.; Tilley, D.A.; Steinhauser, T.; Scott, D.; Thacker, A.; Calderon, V.; Lin, E.; Becke, S.; Krieter, S.; Jansen, O.; Wodarg, F.; Larsen, N.; Binder, A.; Wiesen, C.; Hartney, M.; Bookhagan, L.; Ross, H.; Gay, J.; Snyder, K.; Levy, E.; Davies, J.; Sonig, A.; Rangel-Castilla, L.; Mowla, A.; Shakir, H.; Fennell, V.; Atwal, G.; Natarajan, S.; Beecher, J.; Thornton, J.; Cullen, A.; Brennan, P.; O'Hare, A.; Asadi, H.; Budzik, R.; Taylor, M.; Jennings, M.; Laube, F.; Jackson, J.; Gatrell, R.; Reebel, L.; Albon, A.; Gerniak, J.; Groezinger, K.; Lauf, M.; Voraco, N.; Pema, P.; Davis, T.; Hicks, W.; Mejilla, J.; Teleb, M.; Sunenshine, P.; Russo, E.; Flynn, R.; Twyford, J.; Ver Hage, A.; Smith, E.; Apolinar, L.; Blythe, S.; Maxan, J.; Carter, J.; Taschner, T.; Bergmann, U.; Meckel, S.; Elsheik, S.; Urbach, H.; Maurer, C.; Egger, K.; Niesen, W.D.; Baxter, B.W.; Knox,, A.; Hazelwood, B.; Quarfordt, S.; Calvert, J.; Hawk, H.; Malek,, R.; Padidar, A.; Tolley, U.; Gutierrez, A.; Mordasini, P.; Seip, T.; Balasubramaniam, R.; Gralla, J.; Fischer, U.; Zibold, F.; Piechowiak, E.; DeLeacy, R.; Apruzzeses, R.; Alfonso, C.; Haslett, J.; Fifi, J.; Mocco, J.; Starkman, S.; Guzy,, J.; Grunberg, N.; Szeder, V.; Tateshima, S.; Duckwiler, G.; Nour, M.; Liebeskind, D.; Tang, X.; Hinman, J.; Tipirneni, A.; Yavagal, D.; Guada, L.; Bates, K.; Balladeras, S.; Bokka, S.K.; Suir, S.; Caplan, J.; Kandewall, P.; Peterson, E.; Starke, R.M.; Puri, A.; Hawk, M.; Brooks, C.; L'Heurex, J.; Ty, K.; Rex, D.; Massari, F.; Wakhloo, A.; Lozano, D.; Rodrigua, K.D.; Pierot, L.; Fabienne, M.; Sebastien, S.; Emmoinoli, M.G.;
• Is Part Of: Stroke. Volume 49:Issue 5(2018)
• Publication Date: 2018-05
• Subjects: goals -- humans -- reperfusion -- stroke -- thrombectomy; Cerebrovascular disease -- Periodicals; Cerebral circulation -- Periodicals; 616.81
• DOI: 10.1161/STROKEAHA.117.020125
• Languages: English
• ISSNs: 0039-2499

Abstract

Abstract : 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. Abstract : Supplemental Digital Content is available in the text.