Sex-Based Analysis of Workflow and Outcomes in Acute Ischemic Stroke Patients Treated With Alteplase Versus Tenecteplase.
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Kim Diana J, Singh Nishita, Catanese Luciana, Yu Amy Y X, Demchuk Andrew M, Lloret-Villas Mar I, Deschaintre Yan, Coutts Shelagh B, Khosravani Houman, Appireddy Ramana, Moreau Francois, Gubitz Gord, Tkach Aleksander, Dowlatshahi Dar, Medvedev George, Mandzia Jennifer, Pikula Aleksandra, Shankar Jai, Williams Heather, Manosalva Herbert, Siddiqui Muzaffar, Zafar Atif, Imoukhuede Oje, Hunter Gary, Phillips Stephen, Hill Michael D, Poppe Alexandre Y, Ademola Ayoola, Shamy Michel, Bala Fouzi, Sajobi Tolulope T, Swartz Richard H, Almekhlafi Mohammed A, Menon Bijoy K, Field Thalia S
Аннотация
METHODS: AcT was a multicenter, registry-linked randomized noninferiority trial comparing tenecteplase (0.25 mg/kg) with alteplase (0.9 mg/kg) in acute ischemic stroke within 4.5 hours of onset. In this post hoc analysis, baseline characteristics, workflow times, successful reperfusion (extended Thrombolysis in Cerebral Infarction score ≥2b), symptomatic intracerebral hemorrhage, 90-day functional independence (modified Rankin Scale score, 0-1), and 90-day mortality were compared by sex. Mixed-effects regression analysis was used adjusting for age, stroke severity, and occlusion site for outcomes.
RESULTS: Of 1577 patients treated with intravenous thrombolysis (2019-2022), 755 (47.9%) were women. Women were older (median, 77 [68-86] years in women versus 70 [59-79] years in men) and had a higher proportion of severe strokes (National Institutes of Health Stroke Scale score >15; 32.4% versus 24.9%) and large vessel occlusions (28.7% versus 21.5%) compared with men. All workflow times were comparable between sexes. Women were less likely to achieve functional independence (31.7% versus 39.8%; unadjusted relative risk, 0.80 [95% CI, 0.70-0.91]) and had higher mortality (17.7% versus 13.3%; unadjusted relative risk, 1.33 [95% CI, 1.06-1.69]). Adjusted analysis showed no difference in outcomes between sexes.
CONCLUSIONS: Differences in prognostic factors of age, stroke severity, and occlusion site largely accounted for higher functional dependence and mortality in women. No sex disparities were apparent in workflow quality indicators. Given the integration of the AcT trial into clinical practice, these results provide reassurance that no major sex biases are apparent in acute stroke management throughout participating Canadian centers.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03889249.