Written by Jason Lesnick
Spoon Feed
Tenecteplase was noninferior to alteplase (tPA) in acute ischemic stroke (AIS) patients for excellent functional outcome and safety.
Tenecteplase taking over thrombolysis?
The ORIGINAL RCT was a multicenter, randomized, open-label, blinded endpoint noninferiority trial across 55 stroke centers and neurology clinics in China from 2021 to 2023. Patients had an NIHSS score of 1-25 with a measurable neurologic deficit and ≥ 30 minutes of symptoms. They were randomized within 4.5 hours of symptom onset to receive IV tenecteplase (0.25 mg/kg) or IV alteplase (0.9 mg/kg).
The primary outcome was the proportion of patients with an excellent functional outcome at 90 days (mRS 0 or 1), tested for noninferiority. Safety outcomes measured were symptomatic intracerebral hemorrhage (sICH) and 90 day all-cause mortality.
1,465 patients were included, 446 (30.4%) of whom were female. 72.7% of patients in the tenecteplase group and 70.3% of patients in the alteplase group had excellent functional outcomes (RR 1.03, 95%CI 0.97-1.09) which met the pre-specified noninferiority margin. 90-day mortality was 4.6% in the tenecteplase group and 5.8% in the alteplase group (RR 0.80, 95%CI 0.51-1.23) and sICH occurred in 9 patients (1.2%) in each group (RR 1.01, 95%CI 0.37-2.70).
How will this change my practice?
Similar to other studies we have covered on tenecteplase vs alteplase (TRACE2 and EXTEND-IA TNK), tenecteplase is noninferior to alteplase, and due to ease of administration, which decreases risk of medication errors, seems like the superior choice. We have already switched over to tenecteplase as our first-line thrombolytic in all of the hospitals where I work.
Source
Tenecteplase vs Alteplase for Patients With Acute Ischemic Stroke: The ORIGINAL Randomized Clinical Trial. JAMA. 2024 Nov 5;332(17):1437-1445. doi: 10.1001/jama.2024.14721. PMID: 39264623; PMCID: PMC11393753.
