Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Feb;29(2):609-614.
doi: 10.1111/ene.15126. Epub 2021 Oct 4.

Sex differences in the Norwegian Tenecteplase Trial (NOR-TEST)

Håkon Ihle-Hansen  1 , Else Charlotte Sandset  2   3 , Hege Ihle-Hansen  1   2 , Guri Hagberg  1   2 , Bente Thommessen  4 , Ole Morten Rønning  4   5 , Christopher Elnan Kvistad  6 , Vojtech Novotny  6 , Halvor Naess  6 , Ulrike Waje-Andreassen  6 , Lars Thomassen  6 , Nicola Logallo  6
Affiliations
Randomized Controlled Trial

Sex differences in the Norwegian Tenecteplase Trial (NOR-TEST)

Håkon Ihle-Hansen et al. Eur J Neurol. 2022 Feb.

Abstract

Background and purpose: Sex differences in acute ischemic stroke is of increasing interest in the era of precision medicine. We aimed to explore sex disparities in baseline characteristics, management and outcomes in patients treated with intravenous thrombolysis included in the Norwegian Tenecteplase trial (NOR-TEST).

Methods: NOR-TEST was an open-label, randomized, blinded endpoint trial, performed from 2012 to 2016, comparing treatment with tenecteplase to treatment with alteplase within 4.5 h after acute ischemic stroke symptom onset. Sex differences at baseline, treatment and outcomes were compared using multivariable logistic regression models. Heterogeneity in treatment was evaluated by including an interaction term in the model.

Results: Of 1100 patients enrolled, 40% were women, and in patients aged >80 years, the proportion of women was greater than men (19% vs. 14%; p = 0.02). Women had a lower burden of cardiovascular risk factors, such as diabetes mellitus (11% vs. 15%; p = 0.05) and a higher mean high-density lipoprotein cholesterol level (1.7 ± 0.6 mmol/L vs. 1.3 ± 0.4 mmol/L; p < 0.001), and a higher proportion of women had never smoked (45% vs. 33%; p < 0.001) compared with men. While there was no sex difference in time from onset of symptoms to admission, door to needle time or in-hospital workup, women were admitted with more severe stroke (National Institutes of Health Stroke Scale [NIHSS] score 6.2 ± 5.6 vs. 5.3 ± 5.1; p = 0.01). Stroke mimic diagnosis was more common in women (21% vs. 15%; p = 0.01). There were no significant sex differences in clinical outcome, measured by the NIHSS, the modified Rankin Scale, intracranial hemorrhage and mortality.

Conclusion: Women were underrepresented in number in NOR-TEST. The included women had a lower cardiovascular risk factor burden and more severe strokes.

Trial registration: ClinicalTrials.gov NCT01949948.

Keywords: intravenous thrombolysis; sex differences; stroke; tenecteplase; women's health.

PubMed Disclaimer

References

REFERENCES

    1. Cordonnier C, Sprigg N, Sandset EC, et al. Stroke in women - from evidence to inequalities. Nat Rev Neurol. 2017;13:521-532.
    1. Spence JD, Pilote L. Importance of sex and gender in atherosclerosis and cardiovascular disease. Atherosclerosis. 2015;241:208-210.
    1. Tsivgoulis G, Katsanos AH, Caso V. Under-representation of women in stroke randomized controlled trials: inadvertent selection bias leading to suboptimal conclusions. Ther Adv Neurol Disord. 2017;10:241-244.
    1. Appelros P, Stegmayr B, Terént A. Sex differences in stroke epidemiology: a systematic review. Stroke. 2009;40:1082-1090.
    1. Gargano JW, Wehner S, Reeves MJ. Do presenting symptoms explain sex differences in emergency department delays among patients with acute stroke? Stroke. 2009;40:1114-1120.

Publication types

Associated data