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ECASS III: WHAT DOES IT MEAN

ECASS-III: WHAT DOES IT STAND FOR?. European Cooperative Acute Stroke Study?the third such study. ECASS-III: A little history. In 1995, the NINDS study group reported that patients with acute ischemic stroke (AIS) who received alteplase (IVtPA) within 3 h after the onset of symptoms were at least 3

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ECASS III: WHAT DOES IT MEAN

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    1. ECASS III: WHAT DOES IT MEAN? Kathleen M. Wiese, D.O. Vascular Neurologist Wilmington Health Associates

    2. ECASS-III: WHAT DOES IT STAND FOR? European Cooperative Acute Stroke Study—the third such study

    3. ECASS-III: A little history In 1995, the NINDS study group reported that patients with acute ischemic stroke (AIS) who received alteplase (IVtPA) within 3 h after the onset of symptoms were at least 30% more likely to have minimal or no disability at 90 days compared to those who received placebo.

    4. ECASS-III: A little history Two European trials, ECASS and ECASS II, investigated a time window of up to 6 hours but failed to show efficacy of thrombolytic treatment A subsequent re-analysis of the NINDS study and a pooled analysis of data from 6 randomized trials with 2275 pts showed a clear association between treatment efficacy and the interval between the onset of symptoms and IVtPA treatment

    5. ECASS-III: A little history In the pooled analysis, a favorable outcome was observed even if treatment was given between 3 and 4.5 hours, with an OR of 1.4 for a favorable outcome with IV tPA. This analysis also suggested that a longer time window was not associated with higher rates of sICH or death.

    6. ECASS-III: A little history IV tPA initiated within 3 hours is the only medical therapy currently available for the treatment of acute ischemic stroke (AIS). It is substantially underused, however, due to the restricted time frame for treatment. It is estimated that fewer than 2% of pts receive this therapy in most countries.

    7. ECASS-III: A little history In 2002, the European Medicines Evaluation Agency (EMEA) approved the use of tPA for treatment of stroke within 3h This was contingent on 2 conditions: completion of a registry of pts treated with tPA within 3 h (Safe Implementation of Thrombolysis in Stroke-Monitoring Study, SITS-MOST) and

    8. ECASS-III: History completion of a prospective, randomized, placebo-controlled trial of tPA use within 3-4.5 hours—ECASS-III In 2008, ECASS-III was completed showing that there was benefit to treating with tPA within the 3 to 4.5 hour range.

    9. ECASS-III: The Study 821 patients (18-80 yo) enrolled in multiple centers 418 received tPA within 3-4.5 h 403 were treated with placebo the dosing regimen was 0.9mg/kg (max 90 mg) with 10% of dose given as bolus and the remaining drug as an infusion over an hour the median time to dosing was 3 h 59 mins

    10. ECASS-III: Exclusion Criteria pts older than 80 yo NIHSS>25 anyone taking oral anticoagulants those with previous stroke and diabetes Otherwise, the traditional tPA inclusion and exclusion criteria were expected.

    11. ECASS-III: OUTCOMES Two ways of measuring success: Primary efficacy outcome: modified Rankin scale score of 0 to 1 at 90 d post-treatment Global favorable outcome score=mRS of 0 to 1 at 90 d + Barthel Index score >= 95 + NIHSS score of 0 or 1 + a Glasgow Outcome Score of 1

    12. ECASS-III: OUTCOMES 52.4% of patients treated with tPA attained a mRS score of 0 to 1 (no or minimal disability) at 90 d 45.2% of placebo pts attained such OR 1.34, P=0.04 (statistically significant difference): The odds for a favorable outcome—functionality at 90 days—were 34% higher with the receipt of IV tPA.

    13. ECASS-III: OUTCOMES In the global analysis, the outcome was also improved with alteplase as compared to placebo: OR 1.28, P<0.05 The odds for a favorable outcome –the ability to return to functional independence—after stroke were 28% higher with IVtPA than with placebo.

    14. ECASS-III: ICH rates sICH rate was 2.4% in tPA pts sICH rate was 0.2% in placebo pts P=0.008 Mortality did not differ significantly between groups: 66 patients died 32 of the 418 pts (7.7%) in the IVtPA group 34 of the 403 pts (8.4%) in the placebo group

    15. ECASS-III: SIGNIFICANCE These results are c/w the results from prior studies and pooled analyses of previous trials AHA: Level B evidence that IV tPA can be given safely within the 3-4.5 h time window Confirmation of this study is encouraged

    16. ECASS-III: SIGNIFICANCE Although ECASS-III demonstrated that tPA can be given to stroke pts safely within an extended time window of 3-4.5 hours, delays in evaluation and treatment should be avoided, because the opportunity for improvement is greater with earlier treatment. Treatment with IVtPA is nearly twice as effective when administered within the first 1.5 h post-stroke onset (vs 1.5-3 hrs)

    17. ECASS-III: TIME IS BRAIN Odds ratio for the global outcome: 2.81 for an interval of 0 to 90 mins 1.55 for 91 to 180 mins 1.34 (ECASS-III) to 1.4 (pooled analysis) for 181 to 270 mins

    18. ECASS-III: SIGNIFANCE For 1 patient to have a favorable outcome (0 to 1 on mRS), the number needed to treat is 6 with the extended time window. The likelihood of help to harm ratio is 6:1: ‘We help 6 patients for every 1 we harm when we treat in the 3 to 4.5 hr time window.’ (Saver)

    19. ECASS-III:SIGNIFICANCE ‘Treatment with tPA in the 3 to 4.5 hour window confers benefit to about half as many patients as treatment under 3 hours, with no alteration in the conferral of harm.’ (Saver)

    20. ECASS-III: SIGNIFICANCE The use of IVtPA outside of the 3 hour window has not been FDA approved. Use of IVtPA within the 3-4.5 hour window requires patient and/or POA approval.

    21. Questions?

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