Main surgical procedure problems unaffected by use of renin-angiotensin system inhibitors

There was no distinction in main post-operative problems in sufferers who continued vs. stopped renin-angiotensin system inhibitors (RASIs) earlier than non-cardiac surgical procedure, in line with late-breaking analysis offered in a Sizzling Line session immediately at ESC Congress 2024.

Many sufferers who endure main surgical procedure have a historical past of hypertension, diabetes or coronary heart failure, and obtain persistent therapy with a RASI, specifically an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB). Because of an absence of conclusive knowledge from randomised trials, whether or not to cease RASIs earlier than non-cardiac surgical procedure is unsure. RASI continuation may result in intra-operative hypotension, which might end in post-operative cardiovascular occasions and acute kidney damage (AKI). Then again, RASI discontinuation may trigger post-operative hypertension, coronary heart failure or arrhythmias. The STOP-or-NOT trial was performed to clear up uncertainties and we confirmed no variations in main post-operative outcomes between stopping or not stopping RASIs.”

Matthieu Legrand, Principal Investigator, Professor, College of California at San Francisco, USA

The STOP-or-NOT trial was an open-label, randomized, managed trial performed in 40 French facilities. Sufferers scheduled for elective main non-cardiac surgical procedure who had been chronically handled with ACEIs or ARBs for no less than 3 months earlier than surgical procedure had been randomized 1:1 to proceed RASIs till the day of surgical procedure or to discontinue them 48 hours prior, i.e. to obtain their final dose 3 days earlier than surgical procedure. In each teams, it was advisable that RASI therapy was resumed as quickly as doable after surgical procedure when the oral route was deemed possible.

The first endpoint was a composite of all-cause mortality and main post-operative problems inside 28 days after surgical procedure, outlined as post-operative main cardiovascular occasions (together with acute myocardial infarction, arterial or venous thrombosis, stroke, acute pulmonary edema, cardiogenic shock, acute extreme hypertension disaster and de novo cardiac arrhythmia requiring therapeutic intervention), sepsis or septic shock, respiratory problems, unplanned intensive care unit (ICU) admission or readmission, AKI, hyperkalemia or want for surgical reintervention. Secondary endpoints included hypotension throughout surgical procedure, all-cause mortality, episodes of AKI, post-operative organ failure, and hospital and ICU size of keep through the 28 days after surgical procedure.

In complete, 2,222 sufferers had been randomized. The imply age was 67 years and 65% had been male. Ninety-eight p.c of sufferers had been handled for hypertension, 9% had persistent kidney illness, 8% had diabetes and 4% had coronary heart failure. General, 46% had been handled with ACEIs and 54% had been handled with ARBs at baseline.

For the first endpoint, the charges of all-cause mortality and main post-operative problems had been the identical (22%) within the discontinuation group and the continuation group (danger ratio [RR] 1.02; 95% confidence interval [CI] 0.87-1.19; p=0.85). The impact of the discontinuation vs. continuation of RASIs on the danger of post-operative problems was constant throughout subgroups.

Episodes of hypotension throughout surgical procedure occurred in 41% of sufferers within the discontinuation group and 54% of sufferers within the continuation group (RR 1.31; 95% CI 1.19-1.44). The median (interquartile vary) period of hypotension with a imply arterial stress beneath 60 mmHg was 6 (4-12) minutes within the discontinuation group and 9 (5-16) minutes within the continuation group (imply distinction of three.7 minutes; 95% CI 1.4-6.0). There have been no different variations in trial outcomes.

“Outcomes from the STOP-or-NOT trial could now be used inside guideline suggestions, that are typically weak. Given the shortage of distinction, each methods seem acceptable, indicating {that a} tailor-made method to RASI continuation may very well be used. A discontinuation technique could also be thought-about if there’s a explicit concern for hypotension, whereas continuation could also be most well-liked in sufferers who’re anxious about stopping their medicine or for sensible functions,” concluded Professor Legrand.