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

Zaidat, O. O.; Bozorgchami, H.; Ribo, M.; Saver, J. L.; Mattle, Heinrich; Chapot, R.; Narata, A. P.; Francois, O.; Jadhav, A. P.; Grossberg, J. A.; Riedel, C. H.; Tomasello, A.; Clark, W. M.; Nordmeyer, H.; Lin, E.; Nogueira, R. G.; Yoo, A. J.; Jovin, T. G.; Siddiqui, A. H.; Bernard, T.; ... (2018). Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke, 49(5), pp. 1107-1115. Lippincott Williams & Wilkins 10.1161/strokeaha.117.020125

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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.

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