Bleeding With Asundexian Versus Placebo in Patients With Noncardioembolic Ischemic Stroke or High-Risk TIA: OCEANIC-STROKE Randomized Trial.
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Eikelboom John W, Xu Lizhen, Shoamanesh Ashkan, Dong Qiang, Hirano Teruyuki, Saver Jeffrey L, Masjuan Jaime, Demchuk Andrew M, Cordonnier Charlotte, Bereczki Daniel, Tsivgoulis Georgios, Veltkamp Roland, Staikov Ivan, Bae Hee-Joon, Campbell Bruce C V, Zini Andrea, Lee I-Hui, Kovář Martin, Mikulik Robert, Lemmens Robin, Ferro José M, Robinson Thompson, Christensen Hanne, Ozturk Serefnur, Leker Ronen R, Turcani Peter, Slowik Agnieszka, Amaya Pablo, Hoo Fan Kee, De Marchis Gian Marco, Knoflach Michael, Sylaja P N, Putaala Jukka, Coutinho Jonathan M, van der Worp H Bart, Miglane Evija, Matijošaitis Vaidas, Lindgren Arne G, Silva Gisele Sampaio, Sandset Else Charlotte, Turuspekova Saule T, Colorado Pablo, Kasner Scott E, Keller Lars, Neumann Christoph, Muehlhofer Eva, Iversen Helle Klingenberg, Silva Yolanda, Ayo-Martín Oscar, Shuaib Ashfaq, Wang Ziran, Schulze Karleen, Joundi Raed A, Sharma Mukul
Аннотация
METHODS: In the safety population, 12 254 participants received at least 1 dose of asundexian (n=6124) or placebo (n=6130). Bleeding was categorized by International Society on Thrombosis and Haemostasis criteria as major, clinically relevant nonmajor (CRNM), or minor. While-on-treatment analyses included events through 2 days after the last dose, with death and permanent discontinuation as competing risks.
RESULTS: Major bleeding occurred in 117 (1.9%) participants with asundexian and 107 (1.7%) with placebo (cause-specific hazard ratio [csHR], 1.10 [95% CI, 0.85-1.44]; P=0.46). Major or CRNM bleeding occurred in 339 (5.5%) and 307 (5.0%), respectively (csHR, 1.12 [95% CI, 0.96-1.30]; P=0.16), and any bleeding in 763 (12.5%) and 752 (12.3%) (csHR, 1.02 [95% CI, 0.93-1.13]; P=0.65). Treatment effects for major and major or CRNM bleeding were consistent across prespecified subgroups, including planned dual antiplatelet therapy. Symptomatic intracranial hemorrhage occurred in 41 (0.7%) and 36 (0.6%) participants. Any gastrointestinal bleeding occurred in 186 (3.0%) and 147 (2.4%) (csHR, 1.28 [95% CI, 1.03-1.59]), and lower gastrointestinal bleeding in 102 (1.7%) and 59 (1.0%) (csHR, 1.75 [95% CI, 1.27-2.41]), primarily rectal bleeding. Any procedure-related bleeding and any mucosal bleeding did not differ significantly.
CONCLUSIONS: Asundexian added to antiplatelet therapy reduced ischemic stroke without significantly increasing major, major or CRNM, or any bleeding. Lower gastrointestinal bleeding was more frequent with asundexian, whereas treatment effects on major and major or CRNM bleeding were consistent across prespecified subgroups.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT05686070.