Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke: Pooled Analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data

Joseph P Broderick; Olvert A Berkhemer; Yuko Y Palesch; Diederik W J Dippel; Lydia D Foster; Yvo B W E M Roos; Aad van der Lugt; Thomas A Tomsick; Charles B L M Majoie; Wim H van Zwam; Andrew M Demchuk; Robert J van Oostenbrugge; Pooja Khatri; Hester F Lingsma; Michael D Hill; Bob Roozenbeek; Edward C Jauch; Tudor G Jovin; Bernard Yan; Rüdiger von Kummer; Carlos A Molina; Mayank Goyal; Wouter J Schonewille; Mikael Mazighi; Stefan T Engelter; Craig S Anderson; Judith Spilker; Janice Carrozzella; Karla J Ryckborst; L Scott Janis; Kit N Simpson; IMS III Investigators; MR CLEAN Investigators

doi:10.1161/STROKEAHA.115.011397

Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke: Pooled Analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data

Stroke. 2015 Dec;46(12):3416-22. doi: 10.1161/STROKEAHA.115.011397. Epub 2015 Oct 20.

Authors

Joseph P Broderick¹, Olvert A Berkhemer¹, Yuko Y Palesch¹, Diederik W J Dippel¹, Lydia D Foster¹, Yvo B W E M Roos¹, Aad van der Lugt¹, Thomas A Tomsick¹, Charles B L M Majoie¹, Wim H van Zwam¹, Andrew M Demchuk¹, Robert J van Oostenbrugge¹, Pooja Khatri¹, Hester F Lingsma¹, Michael D Hill¹, Bob Roozenbeek¹, Edward C Jauch¹, Tudor G Jovin¹, Bernard Yan¹, Rüdiger von Kummer¹, Carlos A Molina¹, Mayank Goyal¹, Wouter J Schonewille¹, Mikael Mazighi¹, Stefan T Engelter¹, Craig S Anderson¹, Judith Spilker¹, Janice Carrozzella¹, Karla J Ryckborst¹, L Scott Janis¹, Kit N Simpson¹; IMS III Investigators; MR CLEAN Investigators

Affiliation

¹ From the Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati, OH (J.P.B., P.K., J.S., J.C., T.A.T.); Division of Emergency Medicine (E.C.J.), Department of Public Health Sciences (Y.Y.P., L.D.F.), and Department of Healthcare Management and Leadership (K.N.S.), Medical University of South Carolina, Charleston; Calgary Stroke Program, Seaman Family MR Research Centre, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada (A.M.D., M.D.H., M.G., K.J.R.); the Stroke Institute, University of Pittsburgh Medical Center, PA (T.G.J.); Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia (B.Y.); Department of Neuroradiology, Dresden University Stroke Center, University Hospital, Dresden, Germany (R.v.K.); Neurovascular Unit, Department of Neurology, Hospital Universitari Vall d'Hebron, Barcelona, Spain (C.A.M.); Department of Neurology, University Medical Center Utrecht and the Rudolph Magnus Institute of Neurosciences, Utrecht, the Netherlands (W.J.S.); St. Antonius Hospital, Nieuwegein, the Netherlands (W.J.S.); Department of Neurology and Stroke Center, Lariboisière Hospital, Paris, France (M.M.); Department of Neurology, Basel University Hospital, Basel, Switzerland (S.T.E.); the George Institute for Global Health, Royal Prince Alfred Hospital, University of Sydney, Sydney (C.S.A.); and the National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.); the Department of Radiology (O.A.B., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Academic Medical Center, Amsterdam, the Netherlands; Department of Neurology (D.W.J.D., B.R.), Radiology (A.v.d.L.), and Public Health (H.F.L.), Erasmus MC University Medical Center, Rotterdam, Netherlands; and Department of Radiology (W.H.v.Z.) and N

Abstract

Background and purpose: We assessed the effect of endovascular treatment in acute ischemic stroke patients with severe neurological deficit (National Institutes of Health Stroke Scale score, ≥20) after a prespecified analysis plan.

Methods: The pooled analysis of the Interventional Management of Stroke III (IMS III) and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trials included participants with an National Institutes of Health Stroke Scale score of ≥20 before intravenous tissue-type plasminogen activator (tPA) treatment (IMS III) or randomization (MR CLEAN) who were treated with intravenous tPA ≤3 hours of stroke onset. Our hypothesis was that participants with severe stroke randomized to endovascular therapy after intravenous tPA would have improved 90-day outcome (distribution of modified Rankin Scale scores), when compared with those who received intravenous tPA alone.

Results: Among 342 participants in the pooled analysis (194 from IMS III and 148 from MR CLEAN), an ordinal logistic regression model showed that the endovascular group had superior 90-day outcome compared with the intravenous tPA group (adjusted odds ratio, 1.78; 95% confidence interval, 1.20-2.66). In the logistic regression model of the dichotomous outcome (modified Rankin Scale score, 0-2, or functional independence), the endovascular group had superior outcomes (adjusted odds ratio, 1.97; 95% confidence interval, 1.09-3.56). Functional independence (modified Rankin Scale score, ≤2) at 90 days was 25% in the endovascular group when compared with 14% in the intravenous tPA group.

Conclusions: Endovascular therapy after intravenous tPA within 3 hours of symptom onset improves functional outcome at 90 days after severe ischemic stroke.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424 (IMS III) and ISRCTN10888758 (MR CLEAN).

Keywords: clinical trial; endovascular procedures; stroke; tissue-type plasminogen activator.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

MeSH terms

Aged
Brain Ischemia / diagnosis
Brain Ischemia / epidemiology
Brain Ischemia / therapy*
Disease Management*
Early Medical Intervention
Endovascular Procedures / adverse effects
Endovascular Procedures / methods*
Female
Humans
Male
Middle Aged
Netherlands / epidemiology
Severity of Illness Index*
Statistics as Topic* / methods
Stroke / diagnosis
Stroke / epidemiology
Stroke / therapy*
Tissue Plasminogen Activator / administration & dosage
Tissue Plasminogen Activator / adverse effects
Treatment Outcome

Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke: Pooled Analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data

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Abstract

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