Tenecteplase Versus Alteplase Between 3 and 4.5 Hours in Low National Institutes of Health Stroke Scale. Issue 2 (February 2019)

• Record Type: Journal Article
• Authors: Rønning, Ole Morten; Logallo, Nicola; Thommessen, Bente; Tobro, Håkon; Novotny, Vojtech; Kvistad, Christopher E.; Aamodt, Anne Hege; Næss, Halvor; Waje-Andreassen, Ulrike; Thomassen, Lars
• Is Part Of: Stroke. Volume 50:Issue 2(2019)
• Publication Date: 2019-02
• Subjects: intention to treat analysis -- intracranial hemorrhages -- mortality -- odds ratio -- tenecteplase; Cerebrovascular disease -- Periodicals; Cerebral circulation -- Periodicals; 616.81
• DOI: 10.1161/STROKEAHA.118.024223
• Languages: English
• ISSNs: 0039-2499

Abstract

Abstract : Background and Purpose—: Thrombolysis with alteplase has beneficial effect on outcome and is safe within 4.5 hours. The present study compares the efficacy and safety of tenecteplase and alteplase in patients treated 3 to 4.5 hours after ischemic stroke. Methods—: The data are from a prespecified substudy of patients included in The NOR-TEST (Norwegian Tenecteplase Stroke Trial), a randomized control trial comparing tenecteplase with alteplase. Results—: The median admission National Institutes of Health Stroke Scale for this study population was 3 (interquartile range, 2–6). In the intention-to-treat analysis, 57% of patients that received tenecteplase and 53% of patients that received alteplase reached good functional outcome (modified Rankin Scale score of 0–1) at 3 months (odds ratio, 1.19; 95% CI, 0.68–2.10). The rates of intracranial hemorrhage in the first 48 hours were 5.7% in the tenecteplase group and 6.7% in the alteplase group (odds ratio, 0.84; 95% CI, 0.26–2.70). At 3 months, mortality was 5.7% and 4.5%, respectively. After excluding stroke mimics and patients with modified Rankin Scale score of >1 before stroke, the proportion of patients with good functional outcome was 61% in the tenecteplase group and 57% in the alteplase group (odds ratio, 1.24; 95% CI, 0.65–2.37). Conclusions—: Tenecteplase is at least as effective as alteplase to achieve a good clinical outcome in patients with mild stroke treated between 3 and 4.5 hours after ischemic stroke. Clinical Trial Registration—: URL:https://www.clinicaltrials.gov . Unique identifier: NCT01949948.