Due to its greater ease of administration, increasing trial evidence reporting safety, and recent Australian Guideline endorsement we switched to tenecteplase for stroke thrombolysis from alteplase. We describe our change process and real-world post-implementation outcomes.
We consulted early and widely, conducted pre- and post-implementation surveys, and assessed patient outcomes/treatment metrics pre- and post-implementation, adjusting regression analyses for age, sex, NIHSS, pre-morbid mRS, and thrombectomy.
The Central New Zealand Hyper-Acute Stroke Network serves 1.17 million people. Pre-switch 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 post-implementation. Between January 2018 and February 2021, we treated 555 patients with alteplase pre- and 284 with tenecteplase post-switch, which occured on 2 March 2020. Population-based thrombolysis rates were unchanged (23.9 vs 24.3 per 100,000/year). Patients treated with tenecteplase had greater odds of a favourable mRS using both shift (aOR=1.67; 95%CI=1.19-2.33) and dichotomous analyses (mRS 0-2; aOR=1.95; 95%CI=1.17-3.25) and shorter median (IQR) door-to-needle time (median 53 (38-73.5) vs 61 minutes (45-85), p=0.0002). Symptomatic intracranial haemorrhage rates (tenecteplase 1.8% vs 3.4%, aOR 0.46; 95%CI=0.13-1.63), death by day seven (tenecteplase 7.5% vs 11.8%; aOR 0.54; 95%CI=0.27-1.10), and median (IQR) needle to groin time for the 42 transferred regional patients (tenecteplase 155 (113-248) vs 200 (158-266);p=0.27) did not significantly differ.
Following stakeholder consultation and endorsement, a region-wide switch from alteplase to tenecteplase was successfully implemented. Our real-world outcome data found evidence of benefit and no evidence of harm.