A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Antithrombin Supplementation in Patients at Risk for Antithrombin Deficiency After Cardiac Surgery

Medientyp: E-Artikel
Titel: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Antithrombin Supplementation in Patients at Risk for Antithrombin Deficiency After Cardiac Surgery
Beteiligte: Moront, Michael George; Woodward, Michael K.; Essandoh, Michael K.; Avery, Edwin G.; Reece, T. Brett; Brzezinski, Marek; Spiess, Bruce; Shore-Lesserson, Linda; Chen, Junliang; Henriquez, Waleska; Barceló, Miquel; Despotis, George; Karkouti, Keyvan; Levy, Jerrold H.; Ranucci, Marco; Mondou, Elsa
Erschienen: Ovid Technologies (Wolters Kluwer Health), 2022
Erschienen in: Anesthesia & Analgesia
Sprache: Englisch
DOI: 10.1213/ane.0000000000006145
ISSN: 0003-2999
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Beschreibung: <jats:sec> <jats:title>BACKGROUND:</jats:title> <jats:p>Antithrombin (AT) activity is reduced during cardiac operations with cardiopulmonary bypass (CPB), which is associated with adverse outcomes. Preoperative AT supplementation, to achieve >58% and <100% AT activity, may potentially reduce postoperative morbidity and mortality in cardiac operations with CPB. This prospective, multicenter, randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of preoperative treatment with AT supplementation in patients at risk for low AT activity after undergoing cardiac surgery with CPB.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS:</jats:title> <jats:p>A total of 425 adult patients were randomized (1:1) to receive either a single dose of AT (n = 213) to achieve an absolute increase of 20% above pretreatment AT activity or placebo (n = 212) before surgery. The study duration was approximately 7 weeks. The primary efficacy end point was the percentage of patients with any component of a major morbidity composite (postoperative mortality, stroke, acute kidney injury [AKI], surgical reexploration, arterial or venous thromboembolic events, prolonged mechanical ventilation, and infection) in the 2 groups. Secondary end points included AT activity, blood loss, transfusion requirements, duration of intensive care unit (ICU), and hospital stays. Safety was also assessed.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS:</jats:title> <jats:p>Overall, 399 patients (men, n = 300, 75.2%) with a mean (standard deviation [SD]) age of 66.1 (11.7) years, with the majority undergoing complex surgical procedures (n = 266, 67.9%), were analyzed. No differences in the percentage of patients experiencing morbidity composite outcomes between groups were observed (AT-treated 68/198 [34.3%] versus placebo 58/194 [29.9%]; <jats:italic toggle="yes">P</jats:italic> = .332; relative risk, 1.15). After AT infusion, AT activity was significantly higher in the AT group (108% [42–143]) versus placebo group (76% [40–110]), and lasted up to postoperative day 2. At ICU, the frequency of patients with AT activity ≥58% in the AT group (81.5%) was significantly higher (<jats:italic toggle="yes">P</jats:italic> < .001) versus placebo group (43.2%). Secondary end point analysis did not show any advantage of AT over placebo group. There were significantly more patients with AKI (<jats:italic toggle="yes">P</jats:italic> < .001) in the AT group (23/198; 11.6%) than in the placebo group (5/194, 2.6%). Safety results showed no differences in treatment-emergent adverse events nor bleeding events between groups.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS:</jats:title> <jats:p>AT supplementation did not attenuate adverse postoperative outcomes in our cohort of patients undergoing cardiac surgery with CPB.</jats:p> </jats:sec>
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