Brian van Adel, MD, FRCPC; Wieslaw Oczkowski, PhD, MD, FRCPC
What are the efficacy and safety of IV recombinant tissue plasminogen activator (rt-PA) administered within 6 hours of acute ischemic stroke (AIS) onset?
Randomized controlled trial (Third International Stroke Trial [IST-3]). Current Controlled Trials ISRCTN25765518.
Mostly unblinded (the first 276 patients and their clinicians were blinded).*
156 hospitals with organized systems of stroke care in 12 countries.
3035 patients (53% > 80 years of age, 52% women) who had signs and symptoms of clinically definite acute stroke with known onset time, exclusion of intracranial hemorrhage and structural brain lesions that could mimic stroke by computed tomography or magnetic resonance imaging, and in whom treatment could be started within 6 hours of onset. Exclusion criteria included clear indication for IV thrombolysis with rt-PA or clear contraindication to treatment.
Immediate thrombolysis with IV rt-PA, 0.9 mg/kg to a maximum of 90 mg over 1 hour (n = 1515), or control (n = 1520).
Primary outcome was the proportion of patients alive and independent (Oxford Handicap Score 0 to 2 out of 5) at 6 months. Secondary outcomes included mortality and symptomatic intracranial hemorrhage at 7 days and mortality at 6 months. 3100 patients were needed to detect a 4.7% absolute difference in the primary outcome at 6 months (80% power, α = 0.05).
Groups did not differ for the proportion of patients alive and independent or for mortality at 6 months; however, mortality and symptomatic intracranial hemorrhage were increased in the rt-PA group at 7 days (Table).
IV recombinant tissue plasminogen activator administered within 6 hours of acute ischemic stroke onset did not increase the proportion of patients alive and independent at 6 months.
Recombinant tissue plasminogen activator (rt-PA) within 6 hours of acute ischemic stroke onset†
†RBR = relative benefit reduction; other abbreviations defined in Glossary. RBI, RBR, RRI, RRR, NNH, and CI calculated from adjusted odds ratios and control event rates in article.
Adel BV, Oczkowski W. rt-PA within 6 hours of acute ischemic stroke did not improve clinical outcomes at 6 months. Ann Intern Med. ;157:JC5–7. doi: 10.7326/0003-4819-157-10-201211200-02007
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Published: Ann Intern Med. 2012;157(10):JC5-7.
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