Circulation journal : official journal of the Japanese Circulation Society · 2025
P2Y12 Reaction Units With Prasugrel in Acute Large Artery Atherosclerosis and Transient Ischemic Attack: An Open-Label Randomized Controlled Study, ACUTE-PRAS.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Fujimoto Shigeru, Iguchi Yasuyuki, Yamagami Hiroshi, Koga Masatoshi, Itabashi Ryo, Yakushiji Yusuke, Kowata Kazuma, Kimura Naoto, Terasawa Yuka, Shimizu Takahiro, Miyazaki Yuichi, Oki Koichi, Masuo Osamu, Matsuoka Hideki, Arakawa Shuji, Ueda Toshihiro, Tanaka Ryota, Hashimoto Wataru, Abe Satoru, Kato Go, Furugori Taketoshi, Kimura Kazumi, ACUTE-PRAS Investigators
Аннотация
BACKGROUND: The antiplatelet effect of prasugrel for acute ischemic stroke or transient ischemic attack (TIA) remains unclear. This study compared platelet reactivity between prasugrel and clopidogrel, considering cytochrome P450 family 2 subfamily C member 19 (CYP2C19) gene polymorphisms (extensive metabolizers [EM], intermediate metabolizers [IM], and poor metabolizers [PM]), in patients with acute large artery atherosclerosis (LAA) or high-risk TIA.
METHODS AND RESULTS: In this multicenter open-label randomized controlled study, patients with acute LAA or high-risk TIA received prasugrel or clopidogrel with aspirin. The primary endpoint was platelet reaction units (PRU) 5 days after the start of drug administration, stratified according to CYP2C19 polymorphism. In all, 176 patients participated (88 in each group). Compared with the clopidogrel group, PRU on Day 5 in the prasugrel group were significantly lower in the overall population (adjusted mean 136.0 vs. 169.9; estimated difference -33.9; 95% confidence interval [CI] -49.0, -18.8), EM group (118.5 vs. 144.8; estimated difference -26.2; 95% CI -48.0, -4.4), and IM group (140.3 vs. 173.1; estimated difference -32.8; 95% CI -56.6, -9.0), and tended to be lower in the PM group (164.7 vs. 196.2; estimated difference -31.6; 95% CI -68.3, 5.1). The prevalence of new infarct lesions was comparable between the prasugrel and clopidogrel groups, as was the incidence of adverse events (30.7% vs. 26.1%, respectively) and bleeding events up to Day 5 of administration.
CONCLUSIONS: In patients with acute LAA or high-risk TIA, prasugrel resulted in stable inhibition of platelet aggregation 5 days after starting drug administration compared with clopidogrel, regardless of CYP2C19 polymorphisms.
METHODS AND RESULTS: In this multicenter open-label randomized controlled study, patients with acute LAA or high-risk TIA received prasugrel or clopidogrel with aspirin. The primary endpoint was platelet reaction units (PRU) 5 days after the start of drug administration, stratified according to CYP2C19 polymorphism. In all, 176 patients participated (88 in each group). Compared with the clopidogrel group, PRU on Day 5 in the prasugrel group were significantly lower in the overall population (adjusted mean 136.0 vs. 169.9; estimated difference -33.9; 95% confidence interval [CI] -49.0, -18.8), EM group (118.5 vs. 144.8; estimated difference -26.2; 95% CI -48.0, -4.4), and IM group (140.3 vs. 173.1; estimated difference -32.8; 95% CI -56.6, -9.0), and tended to be lower in the PM group (164.7 vs. 196.2; estimated difference -31.6; 95% CI -68.3, 5.1). The prevalence of new infarct lesions was comparable between the prasugrel and clopidogrel groups, as was the incidence of adverse events (30.7% vs. 26.1%, respectively) and bleeding events up to Day 5 of administration.
CONCLUSIONS: In patients with acute LAA or high-risk TIA, prasugrel resulted in stable inhibition of platelet aggregation 5 days after starting drug administration compared with clopidogrel, regardless of CYP2C19 polymorphisms.