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jueves, 5 de marzo de 2020

Alteplase for Stroke

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By EM PharmD - March 4th, 2020
Ditch Alteplase for Stroke. It’s the easiest way to save $250,000/year.
For almost 25 years, rt-PA (Alteplase) has been the exclusive drug therapy for acute ischemic stroke. Despite the availability of other fibrinolytics that have established roles in cardiology by maintaining therapeutic benefits while improving safety (bleeding), agents like TNKase (aka tenecteplase) have not been a real consideration. But that has been changing over the past few years. 
In fact, a recent meta-analysis of 5 RCTs demonstrated the noninferiority of TNKase when compared to rt-PA in mRS of 0-1 at 3 months [n=1585, 57.9% vs 55.4%, respectively with a random-effect informal risk difference of 4% (95% CI -1% to 8%) meeting non-inferiority margin of -1.3%]. When extending the mRS scale to 0-2 at 3 months, the results were similar, however, the lower end of the 95% CI of -4% was within 2 of the 3 non-inferiority margins (-6.5%, -5% but not -1.3%). Furthermore, there were similar rates of symptomatic ICH between groups of 3% in each group (95% CI -1% to 2%)...
..."The findings suggest that the 0.40 mg/kg dose of tenecteplase does not confer an advantage over the 0.25 mg/kg dose in patients with large vessel occlusion ischemic stroke in whom endovascular thrombectomy is planned.
What’s left unanswered from this study is whether patients not undergoing planned endovascular thrombectomy would see a similar benefit. Based on all the available data, I would estimate that if a difference in efficacy did exist, it would be small and not significant..."

References for Ditch Alteplase for Stroke:
  • Burgos AM, Saver JL. Evidence that Tenecteplase Is Noninferior to Alteplase for Acute Ischemic Stroke Meta-Analysis of 5 Randomized Trials. Stroke. 2019;50:2156–2162
  • Campbell BCV, Mitchell PJ, Churilov L, et al. Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial. JAMA. Published online February 20, 2020.