on behalf of the EXTEND-IA TNK Investigators
Assessment of tenecteplase (TNK) in the elderly is limited. We assessed the safety and efficacy of TNK at 0.40 and 0.25mg/kg dosing in patients >80 years with large vessel occlusion.
Patients were enrolled in parts 1 and 2 of the EXTEND-IA TNK trials. We compared the treatment effect of TNK 0.25mg/kg, TNK 0.40mg/kg, and alteplase 0.90mg/kg, stratifying for patient age (>80 years). Outcomes evaluated include 90-day mRS, all-cause mortality, and symptomatic ICH. Treatment effect was adjusted for baseline NIHSS, age, and time from symptom onset to puncture via mixed effects proportional odds and logistic regression models.
Of the 502 patients included in analysis, 251 patients (50%) were randomized to TNK 0.25mg/kg, 150 (30%) randomized to TNK 0.40mg/kg and 101 (20%) randomized to alteplase. In patients >80 years (n=137), TNK 0.25mg/kg was associated with improved 90-day mRS (aOR=2.70, 95%CI: 1.23-5.94) and reduced mortality (aOR=0.34, 95%CI: 0.13-0.91) versus 0.40mg/kg dosing, and improved 90-day mRS (aOR=2.28, 95%CI: 1.03-5.05) versus alteplase. No difference in 90-day mRS or mortality was detected between alteplase and TNK 0.40mg/kg. Symptomatic ICH was observed in 4 patients treated with TNK 0.40mg/kg, one patient treated with alteplase and zero patients treated with TNK 0.25mg/kg (p=0.01). In patients ≤80 years, no differences in 90-day mRS, mortality, or symptomatic ICH was observed between TNK 0.25mg/kg, TNK 0.40mg/kg, and alteplase.
TNK 0.25mg/kg was associated with improved 90-day mRS and reduced mortality in patients >80 years of age. No differences between the dosing groups was observed in younger patients.
EXTEND-IA TNK Part 1: NCT02388061
EXTEND-IA TNK Part 2: NCT03340493