7. tPA tPA Placebo Placebo 32 20 17 6.4 21 0.1 Excellent Recovery (%) Total Death Rate (%) Hemorrhage NINDS rt-PA Stroke Trial N Engl J Med 333; 24. Dec 1995
8. IV tPA for Acute Ischemic Stroke, Negative studies ECASS I ECASS II ATLANTIS Study/ Year RCT/1995 RCT/1998 RCT/1999 N 620 800 613 rtPA dose 1.1 mg/Kg 0.9 mg/Kg 0.9 mg/Kg Treatment Window 0-6 hs 0-6 hs 3-5 hs Primary Outcome BI, RS at 90 days BI, RS at 90 days NIHHS, BI, RS and GSW at 30 and 90 days Results No difference in Primary end point with increase mortality and risk of ICH in rtPA group Similar to ECASS I without increase in mortality in control group No differences in primary end point between groups. Increase in ICH rate and mortality Inconvenients Less strict BP control, higher dose, and window 80% were treated at 4-5 h Average time to Tx 4.5 hs Observations Subgroup treated within 3 hs had benefit with rtPA
9. RCT of IV tPA for Acute Ischemic Stroke Study N Dose Time window ECASS I 650 1.1 0-6 NINDS 624 0.9 0-3 ECASS II 800 0.9 0-6 ATLANTIS A 142 0.9 0-6 ATLANTIS B 619 0.9 3-5
10. Association of outcome with early stroke treatment: Pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004; 363(9411):768-74 Time (mins) Odds Ratio for favorable outcomes 95% CI Interval 0-90 2.8 1.8-4.5 91-180 1.5 1.1-2.1 181-270 1.4 1.1-1.9 271-360 1.2 0.9-1.5
11. Association of outcome with early stroke treatment: Pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004; 363(9411):768-74