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FACP. Colegio de médicos de Tarragona Nº 4305520 / fgcapriles@gmail.com

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viernes, 27 de mayo de 2016

Low doses tPA in Acute Ischemic Stroke

The ENCHANTED Trial

R.E.B.E.L.EM - May 26, 2016 - Posted by Anand Swaminathan
Ref: 
Anderson CS et al. Low-dose versus standard-dose intravenous alteplase in acute ischemic stroke. NEJM 2016. PMID: 27161018
"Background: Despite continued debate on the efficacy of alteplase (tPA), it currently remains one of the major interventions directed at patients presenting with acute ischemic stroke. The current standard dose of the drug is 0.9 mg/kg given over 1 hour. It is unclear whether lower doses would be equally effective in increasing good neurologic outcomes after stroke while simultaneously decreasing the rate of intracerebral hemorrhage (ICH); the most serious side effect. Evidence showing that lower doses of tPA are non-inferior to standard-dose tPA could lead to a shift in treatment. 
Clinical Question: Is low-dose tPA non-inferior to standard-dose tPA in terms of death or disability at 90 days in the treatment of acute ischemic stroke presenting within 4.5 hours of symptom onset?
Author’s Conclusions: “This trial involving predominantly Asian patients with acute ischemic stroke did not show the noninferiority of low-dose alteplase to standard-dose alteplase with respect to death and disability at 90 days. There were significantly fewer symptomatic intracerebral hemorrhages with low-dose alteplase.”
Our Conclusions: Low-dose tPA did not meet the upper limit of the prespecified non-inferiority threshold for the odds ratio in comparison to standard-dose tPA for the primary outcome of death or disability at 90 days. However, low-dose tPA performed extremely well in this study. Low-dose tPA patients were more likely to be alive at both 7 and 90 days with a lower ICH rate.
Potential Impact to Current Practice: As this study did not show non-inferiority of the low-dose tPA approach, we do not think it will alter overall treatment strategies. However, in patients with CVA who are eligible for systemic thrombolytics and in whom the doctor and patient both think would benefit from the drug but have increased risk of bleeding, low-dose tPA may be provide an alternative approach.
Bottom Line: Low-dose tPA achieved similar outcomes to standard-dose tPA with lower mortality and ICH rates. Although this study does not prove non-inferiority of low-dose tPA, it also does not show superiority of standard-dose tPA.