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Randomized Controlled Trial Multicenter Study
Influence of Device Choice on the Effect of Intra-Arterial Treatment for Acute Ischemic Stroke in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands).
- Diederik W Dippel, Charles B Majoie, Yvo B Roos, Aad van der Lugt, Robert J van Oostenbrugge, Wim H van Zwam, Hester F Lingsma, Peter J Koudstaal, Kilian M Treurniet, Lucie A van den Berg, Debbie Beumer, Puck S Fransen, Olvert A Berkhemer, and MR CLEAN Investigators.
- From the Departments of Neurology (D.W.D., P.J.K., P.S.F., O.A.B.), Radiology (A.v.d.L.), and Public Health (H.F.L.), Erasmus MC University Medical Center Rotterdam, The Netherlands; Departments of Radiology (C.B.M., K.M.T., P.S.F., O.A.B.) and Neurology (Y.B.R., L.A.v.d.B.), Academic Medical Center, Amsterdam, The Netherlands; and Departments of Neurology (R.J.v.O., D.B.) and Radiology (W.H.v.Z., O.A.B.), Maastricht University Medical Center, The Netherlands. d.dippel@erasmusmc.nl.
- Stroke. 2016 Oct 1; 47 (10): 2574-81.
Background And PurposeIntra-arterial treatment by means of retrievable stents has been proven safe and effective. In MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), the choice of the type of thrombectomy device was left to the discretion of the interventionist. The aim of this study was to explore the differences in functional outcome, neurological recovery, reperfusion, extent of infarction, and adverse events according to stent type and make.MethodsThe primary outcome was functional outcome at 90 days, assessed with the modified Rankin Scale (mRS). Neuroimaging outcomes included occlusion on computed tomographic angiography at 24 hours, infarct volume at 5 to 7 days, and modified thrombolysis in cerebral infarction scores. Safety outcomes included death within 90 days and any symptomatic intracerebral hemorrhage. We analyzed possible interactions between stent type and treatment with multiple regression models. Treatment effects were adjusted for patient age, stroke severity, and collateral score.ResultsOf the 500 patients included in the trial, 233 were allocated to intervention. Of these, 124 (53%) were first treated with Trevo (adjusted common odds ratio for shift on the mRS [acOR, 1.98; 95% confidence interval, 1.30-2.92]), 31 (13%) with Solitaire (acOR, 1.90; 95% confidence interval, 0.97-3.73), 40 (17%) with other retrievable stents or mechanical devices (acOR, 0.96; 95% confidence interval, 0.51-3.93], and 38 (16%) could not be treated. There was no interaction between device and treatment effect on functional outcome and all other secondary and safety outcomes.ConclusionsWe found no evidence for a differential effect of thrombectomy for acute ischemic stroke by type of stent.Clinical Trial RegistrationURL: http://www.isrctn.com. Unique identifier: ISRCTN10888758.© 2016 American Heart Association, Inc.
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