Ivabradine in Patients Undergoing Noncardiac Surgery: A Randomized Controlled Trial.
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Szczeklik Wojciech, Fronczek Jakub, Putowski Zbigniew, Włudarczyk Anna, Górka Jacek, Seczyńska Bożena, Gryszówka Dominika, Widawska Agnieszka, Białka Szymon, Palaczyński Piotr, Borys Michał, Kutnik Paweł, Czarnik Tomasz, Szczepańska Anna, Możański Marcin, Mieszkowski Marcin, Kotfis Katarzyna, Trzebicki Janusz, Sadowski Łukasz, Sołek-Pastuszka Joanna, Grudzień Paweł, Mudyna Wojciech, Misiewska-Kaczur Agnieszka, Owczuk Radosław, Kudliński Bartosz, Studzińska Dorota, Pawlik Jarosław, Makowski Adam, Ziętkiewicz Mirosław, Przydacz Mikołaj, Goździk Waldemar, Gola Wojciech, Jasiewicz Przemysław, Zhao Zhiguo, Shyr Yu, Devereaux P J, PERI-CRIT Investigators
Аннотация
METHODS: In this multicenter, double-blind, placebo-controlled trial, we assigned patients ≥45 years of age with, or at risk of, atherosclerotic disease undergoing noncardiac surgery to receive ivabradine (5 mg orally twice daily for up to 7 days, starting 1 hour before surgery) or placebo. The primary outcome was MINS within 30 days from randomization.
RESULTS: All of the 2101 participants who underwent randomization were included in the intention-to-treat population. MINS occurred in 178 of 1050 patients (17.0%) in the ivabradine group and in 159 of 1051 patients (15.1%) in the placebo group (relative risk, 1.12 [95% CI, 0.92 to 1.37]; P=0.25). Enrollment was halted at the prespecified interim analysis because of a conditional power of 6%, below the futility boundary of 20%. The intraoperative mean heart rate was lower in the ivabradine group by 3.2 beats per minute than in the placebo group (95% CI, -4.07 to -2.36), with no difference in intraoperative mean arterial pressure.
CONCLUSIONS: Among patients undergoing noncardiac surgery, ivabradine did not reduce the occurrence of MINS.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05279651.