dc.contributor.author | Zaidat, Osama O. | |
dc.contributor.author | Bozorgchami, Hormozd | |
dc.contributor.author | Ribó, Marc | |
dc.contributor.author | Saver, Jeffrey L. | |
dc.contributor.author | Mattle, Heinrich P. | |
dc.contributor.author | Chapot, René | |
dc.contributor.author | Narata, Ana Paula | |
dc.contributor.author | Francois, Olivier | |
dc.contributor.author | Jadhav, Ashutosh P. | |
dc.contributor.author | Grossberg, Jonathan A. | |
dc.contributor.author | Riedel, Christian H. | |
dc.contributor.author | Tomasello, Alejandro | |
dc.contributor.author | Clark, Wayne M. | |
dc.contributor.author | Nordmeyer, Hannes | |
dc.contributor.author | Lin, Eugene | |
dc.contributor.author | Nogueira, Raul G. | |
dc.contributor.author | Yoo, Albert J. | |
dc.contributor.author | Jovin, Tudor G. | |
dc.contributor.author | Siddiqui, Adnan H. | |
dc.contributor.author | Bernard, Thierry | |
dc.contributor.author | Claffey, Mairsíl | |
dc.contributor.author | Andersson, Tommy | |
dc.date.accessioned | 2018-09-20T16:28:56Z | |
dc.date.available | 2018-09-20T16:28:56Z | |
dc.date.issued | 2018-04-11 | |
dc.identifier.citation | 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 (2018). Primary results of the multicenter arise ii study (analysis of revascularization in ischemic stroke with embotrap). Stroke 49 (5), | |
dc.identifier.issn | 0039-2499,1524-4628 | |
dc.identifier.uri | http://hdl.handle.net/10379/14509 | |
dc.description.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. | |
dc.publisher | Ovid Technologies (Wolters Kluwer Health) | |
dc.relation.ispartof | Stroke | |
dc.rights | Attribution-NonCommercial-NoDerivs 3.0 Ireland | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/3.0/ie/ | |
dc.subject | goals | |
dc.subject | humans | |
dc.subject | reperfusion | |
dc.subject | stroke | |
dc.subject | thrombectomy | |
dc.subject | individual patient data | |
dc.subject | endovascular thrombectomy | |
dc.subject | randomized-trials | |
dc.subject | stent-retriever | |
dc.subject | outcomes | |
dc.subject | metaanalysis | |
dc.subject | therapy | |
dc.subject | device | |
dc.subject | aspiration | |
dc.subject | occlusions | |
dc.title | Primary results of the multicenter arise ii study (analysis of revascularization in ischemic stroke with embotrap) | |
dc.type | Article | |
dc.identifier.doi | 10.1161/strokeaha.117.020125 | |
dc.local.publishedsource | https://www.ahajournals.org/doi/pdf/10.1161/STROKEAHA.117.020125 | |
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