Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap)
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. 
Published: April 2018

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.