Optimal Outcome Measures for Detecting Clinical Benefits of Early Reperfusion: Insights from the DEFUSE Study

Journal of Stroke and Cerebrovascular Diseases

Volumn 17, Issue 4, 2008, Pages 235-240

  Kakuda, Wataru ^a   Hamilton, Scott ^b   Thijs, Vincent N ^c   Lansberg, Maarten G ^b   Kemp, Stephanie ^b   Skalabrin, Elaine ^d   Albers, Gregory W ^b  

^a JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^c UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^d UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

Author keywords

acute ischemic stroke; clinical outcome measure; clinical trial; National Institutes of Health Stroke Scale; Thrombolysis

Indexed keywords

TISSUE PLASMINOGEN ACTIVATOR;

ADULT; AGED; ALGORITHM; ARTICLE; BLOOD CLOT LYSIS; CLINICAL ARTICLE; DIFFUSION WEIGHTED IMAGING; FEMALE; HUMAN; IMAGE ANALYSIS; MALE; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NEUROIMAGING; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REPERFUSION; SCORING SYSTEM; STROKE; TREATMENT OUTCOME;

ACUTE DISEASE; AGED; ALGORITHMS; BIOLOGICAL MARKERS; BRAIN; BRAIN ISCHEMIA; CEREBROVASCULAR CIRCULATION; CLINICAL TRIALS AS TOPIC; DIFFUSION MAGNETIC RESONANCE IMAGING; ENDPOINT DETERMINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; MAGNETIC RESONANCE ANGIOGRAPHY; MALE; OUTCOME ASSESSMENT (HEALTH CARE); PROSPECTIVE STUDIES; REPERFUSION; SEVERITY OF ILLNESS INDEX; STATISTICS, NONPARAMETRIC; THROMBOLYTIC THERAPY; TISSUE PLASMINOGEN ACTIVATOR;

EID: 45449110595     PISSN: 10523057     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jstrokecerebrovasdis.2008.03.001     Document Type: Article

References (14)

1. NINDS rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 333 (1995) 1581-1587
2. Hacke W., Kaste M., Fieschi C., et al. Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke: The European cooperative acute stroke study (ECASS). JAMA 274 (1995) 1017-1025
3. Hacke W., Bluhmki E., Steiner T., et al. Dichotomized efficacy end points and global end-point analysis applied to the ECASS intention-to-treat data set: Post hoc analysis of ECASS I. Stroke 29 (1998) 2073-2075
4. Hacke W., Kaste M., Fieschi C., et al. Randomized double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischemic stroke (ECASS II). Lancet 352 (1998) 1245-1251
5. Furlan A., Higashida R., Wechsler L., et al. Intra-arterial prourokinase for acute ischemic stroke: The PROACT II study; a randomized controlled trial. JAMA 282 (1999) 2003-2011
6. Lees K.R., Zivin J.A., Ashwood T., et al. NXY-059 for acute ischemic stroke. N Engl J Med 354 (2006) 588-600
7. Koziol J.A., and Feng A.C. On the analysis and interpretation of outcome measures in stroke clinical trials: Lessons from the SAINT I study of NXY-059 for acute ischemic stroke. Stroke 37 (2006) 2644-2647
8. Albers G.W., Thijs V.N., Wechsler L., et al. Diffusion and perfusion imaging evaluation for understanding stroke evolution: The DEFUSE study. Ann Neurol 60 (2006) 508-517
9. Chambers J.M., and Hastie T.J. Statistical models in S (1992), Wadsworth, Belmont, CA
10. Saver J.L. Number needed to treat estimates incorporating effects over the entire range of clinical outcomes: Novel derivation method and application to thrombolytic therapy for acute stroke. Arch Neurol 61 (2004) 1066-1070
11. Broderick J.P., Lu M., Kothari R., et al. Finding the most powerful measures of the effectiveness of tissue plasminogen activator in the NINDS tPA stroke trial. Stroke 31 (2000) 2335-2341
12. Khatri P., Neff J., Broderick J.P., et al. Revascularization end points in stroke interventional trials: Recanalization versus reperfusion in IMS-I. Stroke 36 (2005) 2400-2403
13. Khatri P., and Broderick J. Measuring treatment effect in acute stroke trials. Stroke 37 (2006) 2204
14. Bruno A., Saha C., and Williams L.S. Using change in the National Institutes of Health Stroke Scale to measure treatment effect in acute stroke trials. Stroke 37 (2006) 920-921