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Tenecteplase in Ais

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92 views2 pages

Tenecteplase in Ais

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api-550597190
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Tenecteplase for thrombolysis in stroke patients:

Systematic review and meta-analysis 1


March 4, 2021 Lauren Wathen, PharmD

Objective: To compare efficacy and safety of alteplase versus tenecteplase in acute ischemic stroke

Background
AHA/American Stroke Society Guidelines for the Management of Acute Ischemic Stroke 2

IV alteplase is recommended for selected patients who can be treated within 4.5 hours of
ischemic stroke symptom onset or patient last known well or at baseline state.

It may be reasonable to choose tenecteplase over IV alteplase in patients without


contraindications for IV fibrinolysis who are also eligible to undergo mechanical thrombectomy.

Alteplase 3 Tenecteplase 4
FDA Approved Uses: FDA Approved Uses:
- Acute ischemic stroke - Acute myocardial infarction
- Acute myocardial infarction Dosing: 0.25 mg/kg IV bolus, maximum 25 mg
- Acute massive pulmonary embolism Metabolism: Primarily hepatic
Dosing: 0.9 mg/kg, maximum 90 mg; 10% Elimination half-life: Biphasic
given as IV bolus, 90% as drip over 60 min - Initiation: 20-24 minutes
Metabolism: Primarily hepatic - Terminal: 90-130 minutes
Elimination half-life: 5 minutes How supplied: tenecteplase 50 mg kit
How Supplied: alteplase 100 mg kit Cost: $6,028.20 for tenecteplase 50 mg kit
Cost: $8,163.21 for alteplase 100 mg kit Misc: Incompatible with D5

Study Design & Inclusion Criteria


Systematic review and meta-analysis
Inclusion Criteria:
- Original studies comparing tenecteplase to alteplase in human adult patients undergoing
acute thrombolysis for acute ischemic stroke
- Experimental and observational studies included

Baseline Characteristics 
Endpoints
Efficacy Safety
Functional status at 3 months Intracranial hemorrhage (ICH)
-Excellent: mRS=0-1
-Good: mRS=0-2
Early neurological improvement Symptomatic ICH

Recanalization 3-month mortality

Statistics
Each endpoint was defined using absolute risk difference
- Pooled using random effects models
2
Heterogeneity measured using the I  statistic (≥50% considered significant)
Network meta-analysis was used to assess effect of tenecteplase dosing on studied outcomes
- Stratified into 3 groups: 0.1 mg/kg, 0.2-0.25 mg/kg, and 0.4-0.5 mg/kg

Results
N=8 studies included (6 RCTs, 2 Observational studies); N=2031 participants total

Efficacy Safety
Excellent functional outcome Rates of ICH
ARD=0.03, 95% CI [-0.01;0.08] ARD=-0.02, 95% CI [-0.06;0.01]
Good functional outcome
ARD=0.07, 95% CI [-0.02;0.16]
Symptomatic ICH
ARD=0.00, 95% CI [-0.01;0.02]
Early neurological improvement
ARD=0.10, 95% CI [0.02;0.17]
3-month mortality
Rates of recanalization ARD=0.00, 95% CI [-0.03;0.03]
ARD=0.11, 95% CI [0.01;0.20]

I 2 >50% for all efficacy analyses except excellent functional outcome I 2 <50% for all safety analyses

Conclusions
Author's Conclusion: Tenecteplase is a reasonable alternative to alteplase for thrombolysis in
patients with acute ischemic stroke.
Strengths Limitations
Relatively large meta-analysis High rates of heterogeneity in efficacy outcomes
Includes RCTs and observational studies Neurological improvement and recanalization
outcomes not consistent across studies
Most RCTs included were open-label
1. Oliveira M, Fidalgo M, Fontao L, et al. Tenecteplase for thrombolysis in stroke patients: Systematic review and meta-analysis. Am J Emerg Med. 2021;42:31-37.
doi:10.1016/j.ajem.2020.12.026.
2. Powers WJ, Rabenstein AA, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early
Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019;15(12):e344-
e418. doi: 10.1161/STR.0000000000000211.
3. Alteplase. Package insert. Genentech Inc.; 2018.
4. Tenecteplase. Package insert. Genentech Inc.;2018..

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