DIFFERENCES BETWEEN WOMEN AND MEN IN EFFECT OF TENECTEPLACE VERSUS ALTEPLASE IN ACUTE STROKE (NOR-TEST) - A RANDOMIZED, CONTROLLED TRIAL

Differences between women and men in effect of tenecteplace versus alteplase in acute stroke (NOR-TEST) - a randomized, controlled trial Ihle-Hansen H, Ihle-Hansen H, Sandset EC, Hagberg G, Thommessen B, Ru00f8nning OM, Kvistad CE, Novotny V, Nu00e6ss H, Waje-Andreassen U, Thomassen L and Logallo N Background:In the Norwegian Tenecteplase Trial (NOR-TEST), patients with acute ischemic stroke were randomized to either tenecteplase or alteplase. We aimed to compare the proportions in the two treatment groups reaching good clinical outcome according to sex. Methods: NOR-TEST investigated the safety and efficacy of tenecteplase versus alteplase in acute stroke patients eligible for intravenous thrombolysis. Good clinical outcome was defined as modified Rankin Scale 0-1 at three months follow-up (analysed using unadjusted logistic regression). Results: 1100 patients were randomised; 440 (40%) were women. Mean age was the same in women and men (67.8 u00b1 15.2 years). Median NIHSS at admission was 4 (IQR 2-8) in women and 3.5 (2-7) in men. There were no differences in good clinical outcome between tenecteplase and alteplase in women or in men (OR 1.13, 95% CI 0.77 u2013 1.67, and OR 1.08, 95% CI 0.77 u2013 1.49, respectively). There was no heterogeneity in treatment effect (interaction p-value = 0.84). Conclusion: Tenecteplase was not superior to alteplase in the subgroups according to sex. Clinicaltrials.gov, number NCT01949948