Switching to Tenecteplase for Stroke Thrombolysis

Abstract

Background and Purpose: Due to practical advantages, increasing trial safety data, recent Australian Guideline endorsement and local population needs we switched to tenecteplase for stroke thrombolysis from alteplase. We describe our change process and real-world outcome data. Methods: Mixed-methods including stakeholder engagement, preimplementation and postimplementation surveys, and assessment of patient treatment rates, metrics, and clinical outcomes preimplementation and postimplementation adjusting regression analyses for age, sex, National Institutes of Health Stroke Scale, premorbid modified Rankin Scale score, and thrombectomy using New Zealand National Stroke Registry data. Results: Preswitch consultation involved stroke and emergency clinicians, pharmacists, national regulatory bodies, and hospital legal teams. All survey responders (90% response rate) supported the proposed change and remained satisfied 12 months postimplementation. Between January 2018 and February 2021, we treated 555 patients with alteplase and 283 with tenecteplase. Patients treated with tenecteplase had greater odds of a favorable modified Rankin Scale using both shift (adjusted odds ratio, 1.60 [95% CI, 1.15-2.22]) and dichotomous analyses (modified Rankin Scale score, 0-2; adjusted odds ratio, 2.17 [95% CI, 1.31-3.59]) and shorter median (interquartile range) door-to-needle time (median, 53 [38-73.5] versus 61 minutes [45-85], P=0.0002). Symptomatic intracranial hemorrhage rates (tenecteplase 1.8% versus 3.4%; adjusted odds ratio, 0.46 [95% CI, 0.13-1.64]), death by day 7 (tenecteplase 7.5% versus 11.8%; adjusted odds ratio, 0.46 [95% CI, 0.21-0.99]), and median (interquartile range) needle to groin time for the 42 transferred regional patients (tenecteplase 155 [113-248] versus 200 [158-266]; P=0.27) did not significantly differ. Conclusions: Following stakeholder endorsement, a region-wide switch from alteplase to tenecteplase was successfully implemented. We found evidence of benefit and no evidence of harm.