Wojciech Szczeklik, Jakub Fronczek, Zbigniew Putowski, Anna Włudarczyk, Jacek Górka, Bożena Seczyńska, Dominika Gryszówka, Agnieszka Widawska, Szymon Białka, Piotr Palaczyński, Michał Borys, Paweł Kutnik, Tomasz Czarnik, Anna Szczepańska, Marcin Możański, Marcin Mieszkowski, Katarzyna Kotfis, Janusz Trzebicki, Łukasz Sadowski, Joanna Sołek-Pastuszka, Paweł Grudzień, Wojciech Mudyna, Agnieszka Misiewska-Kaczur, Radosław Owczuk, Bartosz Kudliński, Dorota Studzińska, Jarosław Pawlik, Adam Makowski, Mirosław Ziętkiewicz, Mikołaj Przydacz, Waldemar Goździk, Wojciech Gola, Przemysław Jasiewicz, Zhiguo Zhao, Yu Shyr, P J Devereaux
{"title":"Ivabradine in Patients Undergoing Noncardiac Surgery: A Randomized Controlled Trial.","authors":"Wojciech Szczeklik, Jakub Fronczek, Zbigniew Putowski, Anna Włudarczyk, Jacek Górka, Bożena Seczyńska, Dominika Gryszówka, Agnieszka Widawska, Szymon Białka, Piotr Palaczyński, Michał Borys, Paweł Kutnik, Tomasz Czarnik, Anna Szczepańska, Marcin Możański, Marcin Mieszkowski, Katarzyna Kotfis, Janusz Trzebicki, Łukasz Sadowski, Joanna Sołek-Pastuszka, Paweł Grudzień, Wojciech Mudyna, Agnieszka Misiewska-Kaczur, Radosław Owczuk, Bartosz Kudliński, Dorota Studzińska, Jarosław Pawlik, Adam Makowski, Mirosław Ziętkiewicz, Mikołaj Przydacz, Waldemar Goździk, Wojciech Gola, Przemysław Jasiewicz, Zhiguo Zhao, Yu Shyr, P J Devereaux","doi":"10.1161/CIRCULATIONAHA.125.076704","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Perioperative beta blockade lowers heart rate and decreases the risk of myocardial infarction but increases the risk of hypotension, death, and stroke. Ivabradine, a selective heart rate-lowering agent, may prevent prognostically important myocardial injury after noncardiac surgery (MINS) without causing hemodynamic instability.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]; <i>P</i>=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.</p><p><strong>Conclusions: </strong>Among patients undergoing noncardiac surgery, ivabradine did not reduce the occurrence of MINS.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT05279651.</p>","PeriodicalId":10331,"journal":{"name":"Circulation","volume":" ","pages":"1126-1135"},"PeriodicalIF":38.6000,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCULATIONAHA.125.076704","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/30 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Perioperative beta blockade lowers heart rate and decreases the risk of myocardial infarction but increases the risk of hypotension, death, and stroke. Ivabradine, a selective heart rate-lowering agent, may prevent prognostically important myocardial injury after noncardiac surgery (MINS) without causing hemodynamic instability.
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.
期刊介绍：
Circulation is a platform that publishes a diverse range of content related to cardiovascular health and disease. This includes original research manuscripts, review articles, and other contributions spanning observational studies, clinical trials, epidemiology, health services, outcomes studies, and advancements in basic and translational research. The journal serves as a vital resource for professionals and researchers in the field of cardiovascular health, providing a comprehensive platform for disseminating knowledge and fostering advancements in the understanding and management of cardiovascular issues.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
