Ivabradine Shows No Benefit in Preventing Heart Injury During noncardiac Surgery,Trial Finds
Krakow,Poland - A large,randomized clinical trial has found that ivabradine,a medication used to slow heart rate,does not reduce the risk of myocardial injury after noncardiac surgery,even in patients with existing heart disease or risk factors. The PREVENT-MINS trial, halted early due to futility, challenges the hypothesis that simply lowering heart rate during surgery automatically protects the heart.
The study, conducted at 26 hospitals in Poland, involved 2,101 patients aged 45 and older undergoing noncardiac surgery who either had established atherosclerotic disease (coronary artery disease, peripheral artery disease, or prior stroke) or significant risk factors like diabetes, hypertension, or age over 70. Participants were randomly assigned to receive either ivabradine (5mg twice daily for up to 7 days, starting an hour before surgery) or a placebo.
Researchers tracked the incidence of myocardial injury after noncardiac surgery (MINS) within 30 days of randomization. Results revealed MINS occurred in 17.0% of the ivabradine group compared to 15.1% in the placebo group – a statistically non-significant difference (relative risk [RR] 1.12; 95% confidence interval [CI] 0.92 to 1.37; p=0.25).
Interestingly,a subgroup analysis revealed a potential increased risk of MINS among patients with a prior history of coronary artery disease (RR 1.49; 95% CI 1.03 to 2.16), while no such increase was observed in those without a history of the condition (RR 0.98; 95% CI 0.78 to 1.24).
While ivabradine did successfully lower intraoperative heart rate by an average of 3.2 beats per minute compared to placebo, there was no difference in blood pressure. the drug was also associated with a higher incidence of clinically important bradycardia (RR 1.18; 95% CI 1.00 to 1.40).
The trial was originally designed to enroll around 2,500 patients, but the self-reliant Data Monitoring Committee recommended early termination in March 2025 after an interim analysis indicated futility.
“Ivabradine did not reduce the risk of MINS in patients undergoing noncardiac surgery,” stated Professor Wojciech Szczeklik, Principal Investigator from Jagiellonian University Medical College, Krakow, Poland. ”Heart-rate lowering was modest and the possible higher MINS incidence in patients with known coronary artery disease is contrary to our original hypothesis. Further research is needed to establish a method to safely control the heart’s stress associated with noncardiac surgery.”
The rationale behind the study stemmed from the understanding that increased heart rate during surgery can elevate myocardial oxygen consumption, potentially leading to a supply-demand imbalance and heart injury. Beta-blockers have been used to mitigate this risk, but carry their own potential complications. Ivabradine was investigated as a potentially safer alternative due to its more selective heart-rate lowering effect. However, the PREVENT-MINS trial suggests that simply slowing the heart isn’t enough to prevent MINS in this patient population.Source: European Society of Cardiology (ESC) – https://www.escardio.org/The-ESC/press-Office/Press-releases/Ivabradine-did-not-reduce-the-occurrence-of-myocardial-injury-after-noncardiac-surgery
