medwireNews: The rate of all-cause mortality and postoperative complications at 28 days does not differ between patients who stop taking renin-angiotensin system (RAS) inhibitors 48 hours before elective noncardiac surgery and those who continue treatment until the day of surgery, suggests the Stop-or-Not trial.
However, patients who continued RAS inhibitors had a significant 31% greater risk for hypotension during surgery, note the trial researchers in JAMA.
The trial was also presented at the ESC Congress 2024, held in London, UK.
For the open-label randomized trial, which took place at 40 hospitals in France, Matthieu Legrand (University of California, San Francisco, USA) and colleagues enrolled 2222 patients scheduled for elective major noncardiac surgery who were being treated with RAS inhibitors (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for at least 3 months before the surgery.
The investigators randomly assigned the participants to either stop taking their RAS inhibitor therapy 48 hours before surgery (n=1115) or to continue taking RAS inhibitors until the day of surgery (n=1107). The participants had a mean age of 67 years, 65% were men, and the most common co-existing medical condition was hypertension, in 98% of both groups. Only 6% of patients in either group had heart failure as an ongoing condition. The predominant type of elective surgery in both groups was abdominal in 33–34% of patients.
The composite primary endpoint examined was the occurrence of all-cause mortality and major postoperative complications, including cardiovascular events, respiratory complications, acute kidney injury, unplanned admission to an intensive care unit, or sepsis, occurring within 28 days after surgery.
“Patients randomized to the preoperative RAS [inhibitor] continuation strategy had a similar rate of all-cause mortality and major postoperative complications compared with patients randomized to the RAS [inhibitor] discontinuation strategy,” say the researchers. The primary endpoint occurred in 22% of patients in the discontinuation group and in 22% of patients in the continuation group, at a nonsignificant risk ratio (RR) of 1.02.
The secondary outcome of episodes of hypotension during surgery occurred in 41% of the RAS inhibitor discontinuation group and in 54% of the RAS inhibitor continuation group, a significant difference, at a RR of 1.31. However, this higher incidence of intraoperative hypotension in the continuation group “did not translate into a higher risk of all-cause mortality and major postoperative complications,” comment Legrand et al, probably due to the rapid correction of intraoperative hypertension and short duration of low blood pressure, they say.
“The strategy of RAS [inhibitor] management before major surgery has long been a matter of debate, and the lack of large, randomized clinical trials has prevented the establishment of recommendations with high-quality evidence,” state the investigators.
They conclude: “The absence of difference in postoperative outcomes makes both strategies [of RAS inhibitor continuation and discontinuation] acceptable and safe.”
However, they note the limitations of their study, including the few patients enrolled with chronic heart failure and the possible lack of generalizability of the findings to healthcare settings in other countries.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group
JAMA 2024; doi:10.1001/jama.2024.17123
ESC Congress 2024; London, UK: 30 August–2 September
