Primary results of the multicenter ARISE II study (Analysis of Revascularization in Ischemic Stroke With EmboTrap)

Osama O. Zaidat, Hormozd Bozorgchami, Marc Ribó, Jeffrey L. Saver, Heinrich P. Mattle, René Chapot, Ana Paula Narata, Olivier Francois, Ashutosh P. Jadhav, Jonathan A. Grossberg, Christian H. Riedel, Alejandro Tomasello, Wayne Clark, Hannes Nordmeyer, Eugene Lin, Raul G. Nogueira, Albert J. Yoo, Tudor G. Jovin, Adnan H. Siddiqui, Thierry BernardMairsíl Claffey, Tommy Andersson

Research output: Contribution to journalArticle

14 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1107-1115
Number of pages9
JournalStroke
Volume49
Issue number5
DOIs
StatePublished - Jan 1 2018

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Brain Ischemia
Stroke
Equipment and Supplies
Stents
Cerebral Hemorrhage
Safety
Reperfusion
Thrombectomy
Bayes Theorem
Mortality
Multicenter Studies
Meta-Analysis
Prospective Studies
Confidence Intervals

Keywords

  • Goals
  • Humans
  • Reperfusion
  • Stroke
  • Thrombectomy

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Primary results of the multicenter ARISE II study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). / 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; Nordmeyer, Hannes; Lin, Eugene; Nogueira, Raul G.; Yoo, Albert J.; Jovin, Tudor G.; Siddiqui, Adnan H.; Bernard, Thierry; Claffey, Mairsíl; Andersson, Tommy.

In: Stroke, Vol. 49, No. 5, 01.01.2018, p. 1107-1115.

Research output: Contribution to journalArticle

Zaidat, OO, Bozorgchami, H, Ribó, M, Saver, JL, Mattle, HP, Chapot, R, Narata, AP, Francois, O, Jadhav, AP, Grossberg, JA, Riedel, CH, Tomasello, A, Clark, W, Nordmeyer, H, Lin, E, Nogueira, RG, Yoo, AJ, Jovin, TG, Siddiqui, AH, Bernard, T, Claffey, M & Andersson, T 2018, 'Primary results of the multicenter ARISE II study (Analysis of Revascularization in Ischemic Stroke With EmboTrap)', Stroke, vol. 49, no. 5, pp. 1107-1115. https://doi.org/10.1161/STROKEAHA.117.020125
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 ; Nordmeyer, Hannes ; Lin, Eugene ; Nogueira, Raul G. ; Yoo, Albert J. ; Jovin, Tudor G. ; Siddiqui, Adnan H. ; Bernard, Thierry ; Claffey, Mairsíl ; Andersson, Tommy. / Primary results of the multicenter ARISE II study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). In: Stroke. 2018 ; Vol. 49, No. 5. pp. 1107-1115.
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T1 - Primary results of the multicenter ARISE II study (Analysis of Revascularization in Ischemic Stroke With EmboTrap)

AU - Zaidat, Osama O.

AU - Bozorgchami, Hormozd

AU - Ribó, Marc

AU - Saver, Jeffrey L.

AU - Mattle, Heinrich P.

AU - Chapot, René

AU - Narata, Ana Paula

AU - Francois, Olivier

AU - Jadhav, Ashutosh P.

AU - Grossberg, Jonathan A.

AU - Riedel, Christian H.

AU - Tomasello, Alejandro

AU - Clark, Wayne

AU - Nordmeyer, Hannes

AU - Lin, Eugene

AU - Nogueira, Raul G.

AU - Yoo, Albert J.

AU - Jovin, Tudor G.

AU - Siddiqui, Adnan H.

AU - Bernard, Thierry

AU - Claffey, Mairsíl

AU - Andersson, Tommy

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - Goals

KW - Humans

KW - Reperfusion

KW - Stroke

KW - Thrombectomy

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