Heinrich P Mattle1, Carl Scarrott2, Mairsil Claffey3, John Thornton4, Juan Macho5, Christian Riedel6, Michael Söderman7, Alain Bonafé8, Michel Piotin9, John Newell10, Tommy Andersson7,11. 1. 1 Department of Neurology, Inselspital, University of Bern, Bern, Switzerland. 2. 2 School of Mathematics and Statistics, University of Canterbury, Canterbury, New Zealand. 3. 3 Cerenovus, Galway, Ireland. 4. 4 Department of Neuroradiology, Beaumont Hospital, Dublin, Ireland. 5. 5 Hospital Clinico de Barcelona, Barcelona, Spain. 6. 6 Department of Neuroradiology, University Hospital, Kiel, Germany. 7. 7 Departments of Neuroradiology and Clinical Neuroscience, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden. 8. 8 CHU Montpellier, Hôpital Gui de Chauliac, Montpellier, France. 9. 9 Hôpital Rothschild, Paris, France. 10. 10 School of Mathematics, Statistics and Applied Mathematics, National University of Ireland, Galway, Ireland. 11. 11 Department of Medical Imaging, AZ Groeninge, Kortrijk, Belgium.
Abstract
BACKGROUND AND PURPOSE: The goal of the analysis of revascularisation in ischaemic stroke with EmboTrap study (ARISE I) was to demonstrate the effectiveness of EmboTrap. METHODS: ARISE I was an open label, single arm, multicentre, prospective study for the treatment of acute stroke due to large vessel occlusion. The primary outcome was revascularisation of the target vessel as measured by the modified thrombolysis in cerebrovascular infarction (mTICI) score of at least 2b following thrombectomy with EmboTrap. For comparison of the ARISE I results a meta-analysis of eight randomised controlled trials was performed. RESULTS: ARISE I enrolled 40 patients. Their baseline characteristics that are predictors of stroke outcome and procedure timings in ARISE I were similar to those reported in recent randomised controlled trials. The primary outcome, good revascularisation rates (mTICI 2b/3 scores) after three or fewer passes with EmboTrap were 75% (95% confidence interval (CI) 62-88%), which is the same as 74% found in randomised controlled trials (difference of 0.8%, P = 0.95). After additional EmboTrap passes or the use of another device mTICI 2b/3 scores rose to 85% (95% CI 74-96%), which was also similar to the randomised controlled trials (difference 11%, P = 0.38). The high revascularisation rates in ARISE I converted into 64% good clinical outcomes (modified Rankin scale ≤2) compared to 50% in randomised controlled trials (difference 14%; 95% CI -13.7-41.7%; P = 0.32). CONCLUSIONS: ARISE I demonstrates that thrombectomy using the EmboTrap stent retriever yields similar results to devices that were used in recent randomised controlled trials for the treatment of stroke due to large vessel occlusions. ClinicalTrials.gov identifier NCT02190552.
BACKGROUND AND PURPOSE: The goal of the analysis of revascularisation in ischaemic stroke with EmboTrap study (ARISE I) was to demonstrate the effectiveness of EmboTrap. METHODS: ARISE I was an open label, single arm, multicentre, prospective study for the treatment of acute stroke due to large vessel occlusion. The primary outcome was revascularisation of the target vessel as measured by the modified thrombolysis in cerebrovascular infarction (mTICI) score of at least 2b following thrombectomy with EmboTrap. For comparison of the ARISE I results a meta-analysis of eight randomised controlled trials was performed. RESULTS: ARISE I enrolled 40 patients. Their baseline characteristics that are predictors of stroke outcome and procedure timings in ARISE I were similar to those reported in recent randomised controlled trials. The primary outcome, good revascularisation rates (mTICI 2b/3 scores) after three or fewer passes with EmboTrap were 75% (95% confidence interval (CI) 62-88%), which is the same as 74% found in randomised controlled trials (difference of 0.8%, P = 0.95). After additional EmboTrap passes or the use of another device mTICI 2b/3 scores rose to 85% (95% CI 74-96%), which was also similar to the randomised controlled trials (difference 11%, P = 0.38). The high revascularisation rates in ARISE I converted into 64% good clinical outcomes (modified Rankin scale ≤2) compared to 50% in randomised controlled trials (difference 14%; 95% CI -13.7-41.7%; P = 0.32). CONCLUSIONS: ARISE I demonstrates that thrombectomy using the EmboTrap stent retriever yields similar results to devices that were used in recent randomised controlled trials for the treatment of stroke due to large vessel occlusions. ClinicalTrials.gov identifier NCT02190552.
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