Safety and efficacy of MRI-based selection for recombinant tissue plasminogen activator treatment: Responder analysis of outcome in the 3-hour time window

Cerebrovascular Diseases

Volumn 27, Issue 3, 2009, Pages 223-229

  Sølling, Christine ^a   Hjort, Niels ^a   Ashkanian, Mahmoud ^a   Østergaard, Leif ^a   Andersen, Grethe ^a  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

Author keywords

Acute ischemic stroke; Acute management; Imaging; Recombinant tissue plasminogen activator

Indexed keywords

ALTEPLASE;

ADULT; AGED; ARTICLE; BRAIN HEMORRHAGE; BRAIN INFARCTION; CEREBROVASCULAR ACCIDENT; COMPUTER ASSISTED TOMOGRAPHY; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; FEMALE; HOSPITALIZATION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; SYMPTOMATOLOGY; TREATMENT OUTCOME;

AGED; CEREBRAL ANGIOGRAPHY; CEREBRAL HEMORRHAGE; DIFFUSION MAGNETIC RESONANCE IMAGING; DRUG ADMINISTRATION SCHEDULE; FEMALE; FIBRINOLYTIC AGENTS; HUMANS; INFUSIONS, INTRAVENOUS; MAGNETIC RESONANCE ANGIOGRAPHY; MALE; MIDDLE AGED; PATIENT SELECTION; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; RECOMBINANT PROTEINS; REGISTRIES; SEVERITY OF ILLNESS INDEX; STROKE; THROMBOLYTIC THERAPY; TISSUE PLASMINOGEN ACTIVATOR; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME;

EID: 58749092194     PISSN: 10159770     EISSN: None     Source Type: Journal    
DOI: 10.1159/000196819     Document Type: Article

References (25)

1. Kang DW, Chalela JA, Dunn W, Warach S: MRI screening before standard tissue plasminogen activator therapy is feasible and safe. Stroke 2005;36:1939-1943.
2. Thomalla G, Schwark C, Sobesky J, Bluhmki E, Fiebach JB, Fiehler J, Zaro WO, Kucinski T, Juettler E, Ringleb PA, Zeumer H, Weiller C, Hacke W, Schellinger PD, Rother J: Outcome and symptomatic bleeding complications of intravenous thrombolysis within 6 h in MRI-selected stroke patients: comparison of a German multicenter study with the pooled data of ATLANTIS, ECASS, and NINDS tPA trials. Stroke 2006;37:852-858.
3. Kohrmann M, Juttler E, Fiebach JB, Huttner HB, Siebert S, Schwark C, Ringleb PA, Schellinger PD, Hacke W: MRI versus CT-based thrombolysis treatment within and beyond the 3 h time window after stroke onset: a cohort study. Lancet Neurol 2006;5:661-667.
4. Fiebach JB, Schellinger PD, Jansen O, Meyer M, Wilde P, Bender J, Schramm P, Juttler E, Oehler J, Hartmann M, Hahnel S, Knauth M, Hacke W, Sartor K: CT and diffusion-weighted MR imaging in randomized order: diffusion-weighted imaging results in higher accuracy and lower interrater variability in the diagnosis of hyperacute ischemic stroke. Stroke 2002;33:2206-2210.
5. Derex L, Hermier M, Adeleine P, Pialat JB, Wiart M, Berthezene Y, Philippeau F, Honnorat J, Froment JC, Trouillas P, Nighoghossian N: Clinical and imaging predictors of intracerebral haemorrhage in stroke patients treated with intravenous tissue plasminogen activator. J Neurol Neurosurg Psychiatry 2005;76:70-75.
6. Scott PA, Silbergleit R: Misdiagnosis of stroke in tissue plasminogen activator-treated patients: characteristics and outcomes. Ann Emerg Med 2003;42:611-618.
7. Selim M, Kumar S, Fink J, Schlaug G, Caplan LR, Linfante I: Seizure at stroke onset: should it be an absolute contraindication to thrombolysis? Cerebrovasc Dis 2002;14:54-57.
8. Barber PA, Zhang J, Demchuk AM, Hill MD, Buchan AM: Why are stroke patients excluded from TPA therapy? An analysis of patient eligibility. Neurology 2001;56:1015-1020.
9. Smith EE, Abdullah AR, Petkovska I, Rosenthal E, Koroshetz WJ, Schwamm LH: Poor outcomes in patients who do not receive intravenous tissue plasminogen activator because of mild or improving ischemic stroke. Stroke 2005;36:2497-2499.
10. Gonzales N, Albright KC, Noser EA, Khaja AM, Shaltoni HM, Romman A, Baraniuk MS, Moye LA, Grotta JC: 'Mild strokes' should not exclude patients from therapy. Stroke 2006;37:621.
11. Murray GD, Barer D, Choi S, Fernandes H, Gregson B, Lees KR, Maas AI, Marmarou A, Mendelow AD, Steyerberg EW, Taylor GS, Teasdale GM, Weir CJ: Design and analysis of phase III trials with ordered outcome scales: the concept of the sliding dichotomy. J Neurotrauma 2005;22:511-517.
12. Young FB, Lees KR, Weir CJ: Improving trial power through use of prognosis-adjusted end points. Stroke 2005;36:597-601.
13. Adams HP Jr, Leclerc JR, Bluhmki E, Clarke W, Hansen MD, Hacke W: Measuring outcomes as a function of baseline severity of ischemic stroke. Cerebrovasc Dis 2004;18:124-129.
14. Thomassen L, Waje-Andreassen U, Naess H, Elvik MK, Russell D: Long-term effect of intravenous thrombolytic therapy in acute stroke: responder analysis versus uniform analysis of excellent outcome. Cerebrovasc Dis 2005;20:470-474.
15. Saver JL, Yafeh B: Confirmation of tPA treatment effect by baseline severity-adjusted end point reanalysis of the NINDS-tPA stroke trials. Stroke 2007;38:414-416.
16. Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G: Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet 2007;369:275-282.
17. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med 1995;333:1581-1587.
18. Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P: Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet 1998;352:1245-1251.
19. Hacke W, Kaste M, Olsen TS, Orgogozo JM, Bogousslavsky J: European Stroke Initiative: recommendations for stroke management. Organisation of stroke care. J Neurol 2000;247:732-748.
20. Rother J, Schellinger PD, Gass A, Siebler M, Villringer A, Fiebach JB, Fiehler J, Jansen O, Kucinski T, Schoder V, Szabo K, Junge-Hulsing GJ, Hennerici M, Zeumer H, Sartor K, Weiller C, Hacke W: Effect of intravenous thrombolysis on MRI parameters and functional outcome in acute stroke <6 h. Stroke 2002;33:2438-2445.
21. Savitz SI, Lew R, Bluhmki E, Hacke W, Fisher M: Shift analysis versus dichotomization of the modified Rankin scale outcome scores in the NINDS and ECASS-II trials. Stroke 2007;38:3205-3212.
22. von Kummer R: Effect of training in reading CT scans on patient selection for ECASS II. Neurology 1998;51:S50-S52.
23. Chalela JA, Kidwell CS, Nentwich LM, Luby M, Butman JA, Demchuk AM, Hill MD, Patronas N, Latour L, Warach S: Magnetic resonance imaging and computed tomography in emergency assessment of patients with suspected acute stroke: a prospective comparison. Lancet 2007;369:293-298.
24. Davis DP, Robertson T, Imbesi SG: Diffusion-weighted magnetic resonance imaging versus computed tomography in the diagnosis of acute ischemic stroke. J Emerg Med 2006;31:269-277.
25. Hjort N, Butcher K, Davis SM, Kidwell CS, Koroshetz WJ, Rother J, Schellinger PD, Warach S, Østergaard L: Magnetic resonance imaging criteria for thrombolysis in acute cerebral infarct. Stroke 2005;36:388-397.