Abstract 81: Tenecteplase is Non-Inferior to Alteplase for Acute Ischemic Stroke: Formal Meta-Analysis of 5 Completed Randomized Trials
| Autor: | Adrian M Burgos, Jeffrey L. Saver |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Advanced and Specialized Nursing
medicine.medical_specialty business.industry medicine.medical_treatment Tenecteplase Thrombolysis Guideline medicine.disease law.invention Randomized controlled trial law Meta-analysis Internal medicine Medicine In patient Neurology (clinical) Cardiology and Cardiovascular Medicine business Acute ischemic stroke Stroke medicine.drug |
| Zdroj: | Stroke. 50 |
| ISSN: | 1524-4628 0039-2499 |
| Popis: | Background: Tenecteplase (TNK), a newer lytic easier to administer than alteplase (ALT), was recognized in the 2018 US AHA/ASA Guideline Update as an alternative to ALT in patients with acute ischemic stroke (AIS). But this recommendation was advanced based on informal consideration, rather than formal meta-analysis, of completed RCTs. Methods: Systematic literature search identified all RCTs comparing TNK vs ALT; formal non-inferiority meta-analysis was conducted per PRISMA guidelines. Based on a prior non-inferiority lytic AIS trial (ENCHANTED), the primary meta-analytic endpoint was disability-free (mRS 0-1) outcome at 3m, with a non-inferiority margin of 0.88. Additional efficacy and safety outcomes were also analyzed. Results: The systematic search identified 5 trials enrolling 1585 patients (828 TNK, 757 ALT). Across all trials, mean age was 70.8, 58.5% were male, baseline NIHSS was mean 7.0, and time from last known well to treatment start was mean 148 mins. All ALT patients received standard 0.9 mg/kg dosing, while TNK dosing was 0.1 mg/kg in 6.8%, 0.25 mg/kg in 24.6%, and 0.4 mg/kg in 68.6%. For the primary endpoint, rates of disability-free (mRS 0-1) 3m outcome were: TNK 57.9% vs ALT 55.4%, RR 1.06 (95%CI 0.98-1.16) (Figure). The lower 95%CI bound fell well within the 0.88 non-inferiority margin. Similar results were seen for the additional efficacy endpoints: functional independence (mRS 0-2): TNK 71.9% vs ALT 70.5%, RR 1.02 (95% CI 0.96-1.09); and mRS shift analysis. For safety endpoints, lower event rates reduced power, but point estimates were also consistent with non-inferiority: Symptomatic ICH - TNK 3% vs ALT 3%, RR 0.96 (95% CI 0.56-1.65). Death – TNK 7.6% vs ALT 8.1%, RR 0.86 (95% CI 0.62-1.21). Conclusion: Accumulated clinical trial evidence provides strong evidence indicating that TNK is non-inferior to ALT in the treatment of AIS. These findings provide formal support for the recent guideline recommendation to consider TNK an alternative to ALT. |
| Databáze: | OpenAIRE |
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