Number needed to treat to benefit and to harm for intravenous tissue plasminogen activator therapy in the 3- to 4.5-hour window Joint outcome table analysis of the ECASS 3 trial

Stroke

Volumn 40, Issue 7, 2009, Pages 2433-2437

  Saver, Jeffrey L ^a,b   Gornbein, Jeffrey ^a   Grotta, James ^c   Liebeskind, David ^a,b   Lutsep, Helmi ^d   Schwamm, Lee ^e   Scott, Phillip ^f   Starkman, Sidney ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF TEXAS   (United States)

^d OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^e MASSACHUSETTS GENERAL HOSPITAL   (United States)

^f UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

Author keywords

Cerebral infarction; Clinical trial; Fibrinolysis; Ischemic stroke; Thrombolysis

Indexed keywords

ALTEPLASE; PLACEBO;

ALGORITHM; ARTICLE; BOOTSTRAPPING; BRAIN ISCHEMIA; CONTROLLED STUDY; DISABILITY; EFFECT SIZE; HUMAN; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; RANDOM SAMPLE; TREATMENT OUTCOME;

ALGORITHMS; CLINICAL TRIALS AS TOPIC; FIBRINOLYTIC AGENTS; HUMANS; STROKE; THROMBOLYTIC THERAPY; TIME FACTORS; TISSUE PLASMINOGEN ACTIVATOR; TREATMENT OUTCOME;

EID: 67650084702     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/STROKEAHA.108.543561     Document Type: Article

References (22)

1. Saver JL. Time is brain-quantified. Stroke. 2006;37:263-266.
2. Marler JR, Tilley BC, Lu M, Brott TG, Lyden PC, Grotta JC, Broderick JP, Levine SR, Frankel MP, Horowitz SH, Haley EC Jr, Lewandowski CA, Kwiatkowski TP. Early stroke treatment associated with better outcome: the NINDS rt-PA stroke study. Neurology. 2000;55:1649 -1655.
3. Wardlaw J, del Zoppo G, Yamaguchi T, Berge E. Thrombolysis for acute ischaemic stroke. Cochrane Database System Rev 2003.
4. Saver JL, Kidwell CS, Starkman S. Commentary: Thrombolysis in stroke: it works! BMJ. 2002;324:727-729.
5. Hacke W, Donnan G, Fieschi C, Kaste M, von Kummer R, Broderick JP, Brott T, Frankel M, Grotta JC, Haley EC Jr, Kwiatkowski T, Levine SR, Lewandowski C, Lu M, Lyden P, Marler JR, Patel S, Tilley BC, Albers G, Bluhmki E, Wilhelm M, Hamilton S; ATLANTIS Trials Investigators; ECASS Trials Investigators; NINDS rt-PA Study Group Investigators. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004;363: 768-774.
6. NINDS rt-PA Stroke Study Group. NINDS t-PA Stroke Study Data Set. National Technical Information Service, 2006. Product number: PB2006-500032.
7. Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008;359:1317-1329.
8. McAlister FA, Straus SE, Guyatt GH, Haynes RB. Users' guides to the medical literature: XX. Integrating research evidence with the care of the individual patient Evidence-Based Medicine Working Group. JAMA. 2000;283:2829-2836.
9. Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomised trials. BMJ. 1998;316:690-693.
10. Walter SD. Number needed to treat (NNT): estimation of a measure of clinical benefit. Stat Med. 2001;20:3947-3962.
11. Saver JL. Number needed to treat estimates incorporating effects over the entire range of clinical outcomes: novel derivation method and appli-cation to thrombolytic therapy for acute stroke. Arch Neurol. 2004;61: 1066-1070.
12. Saver JL. Novel end point analytic techniques and interpreting shifts across the entire range of outcome scales in acute stroke trials. Stroke. 2007;38:3055-3062.
13. Tissue plasminogen activator (tPA): What you should know [online]. Available at: http://www.giveme5forstroke.org/docs/tPA-Flyer.pdf. Accessed November 11, 2008.
14. Saver JL. Clinical impact of NXY-059 demonstrated in the SAINT I trial: derivation of number needed to treat for benefit over entire range of functional disability. Stroke. 2007;38:1515-1518.
15. Lansberg MG, Schrooten M, Bluhmki E, Thijs VN, Saver JL. Treatment time-specific number needed to treat estimates for tissue plasminogen activator therapy in acute stroke based on shifts over the entire range of the modified Rankin Scale. Stroke. 2009;40:2079-2084.
16. Samsa G, Matchar D, Goldstein L, Bonito A, Duncan PW, Lispscomb J, Enarson C, Witter D, Venus P, Paul JE, Weinberger M. Utilities for major stroke: results from a survey of preferences among persons at increased risk for stroke. Am Heart J. 1998;136:703-713.
17. Demaerschalk BM. Thrombolytic therapy for acute ischemic stroke: the likelihood of being helped versus harmed. Stroke. 2007;38: 2215-2216.
18. van Exel NJ, Scholte op Reimer WJ, Koopmanschap MA. Assessment of post-stroke quality of life in cost-effectiveness studies: the usefulness of the Barthel Index and the EuroQoL-5D. Qual Life Res. 2004;13:427-433.
19. Patel MD, Tilling K, Lawrence E, Rudd AG, Wolfe CD, McKevitt C. Relationships between long-term stroke disability, handicap and health-related quality of life. Age Ageing. 2006;35:273-279.
20. Savitz SI, Benatar M, Saver JL, Fisher M. Outcome analysis in clinical trial design for acute stroke: physicians' attitudes and choices. Cerebrovasc Dis. 2008;26:156 -162.
21. NINDS rt-PA Stroke Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:1581-1587.
22. Saver JL. Hemorrhage after thrombolytic therapy for stroke: the clinically relevant number needed to harm. Stroke. 2007;38:2279-2283.