Prospective Randomized Evaluation of Preoperative Angiotensin-Converting Enzyme Inhibition (PREOP-ACEI)
BACKGROUND: Intraoperative hypotension is associated with an increased risk of end organ damage and death. The transient preoperative interruption of angiotensin-converting enzyme inhibitor (ACEI) therapy prior to cardiac and vascular surgeries decreases the occurrence of intraoperative hypotension.
OBJECTIVE: We sought to compare the effect of two protocols for preoperative ACEI management on the risk of intraoperative hypotension among patients undergoing noncardiac, nonvascular surgeries.
DESIGN: Prospective, randomized study.
SETTING: Midwestern urban 489-bed academic medical center.
PATIENTS: Patients taking an ACEI for at least six weeks preoperatively were considered for inclusion.
INTERVENTIONS: Randomization of the final preoperative ACEI dose to omission (n = 137) or continuation (n = 138).
MEASUREMENTS: The primary outcome was intraoperative hypotension, which was defined as any systolic blood pressure (SBP) < 80 mm Hg. Postoperative hypotensive (SBP < 90 mm Hg) and hypertensive (SBP > 180 mm Hg) episodes were also recorded. Outcomes were compared using Fisher’s exact test.
RESULTS: Intraoperative hypotension occurred less frequently in the omission group (76 of 137 [55%]) than in the continuation group (95 of 138 [69%]) (RR: 0.81, 95% CI: 0.67 to 0.97, P = .03, NNH 7.5). Postoperative hypotensive events were also less frequent in the ACEI omission group (RR: 0.49, 95% CI: 0.28 to 0.86, P = .02) than in the continuation group. However, postoperative hypertensive events were more frequent in the omission group than in the continuation group (RR: 1.95, 95%: CI: 1.14 to 3.34, P = .01).
CONCLUSION: The transient preoperative interruption of ACEI therapy is associated with a decreased risk of intraoperative hypotension.
REGISTRATION: ClinicalTrials.gov: NCT01669434.
© 2018 Society of Hospital Medicine
Over 7 million surgeries are performed in United States hospitals each year. Among these surgeries, approximately 85% are noncardiac, nonvascular (NCNV) procedures.1,2 Although the preoperative use of an angiotensin-converting enzyme inhibitor (ACEI) can be expected in as many as 13% of these surgeries,3 the optimal preoperative ACEI management strategy for patients undergoing NCNV surgeries is poorly understood.
High-quality evidence suggests that renin–angiotensin–aldosterone system (RAAS) inhibitors are associated with intraoperative hypotension among patients undergoing cardiac or vascular surgeries.4-6 Intraoperative hypotension increases the risk of 30-day mortality,7 and the duration of intraoperative hypotension increases the risk of end organ damage.8,9 This body of evidence suggests that withholding ACEIs prior to cardiac and vascular surgeries is safer than continuing ACEIs without interruption.
The evidence concerning perioperative management of ACEIs is inconclusive for patients undergoing NCNV procedures. Some studies comparing patients taking or not taking a RAAS inhibitor preoperatively describe negligible differences in the frequency of intraoperative hypotensive episodes or complications.3,10 Others have found an increased risk of intraoperative hypotension and associated postoperative adverse events in patients continuing RAAS inhibitors preoperatively.11,12 Current guideline discrepancies reflect the uncertainty of the evidence. The guidelines set by the American College of Cardiology and American Heart Association (ACC/AHA) suggest the uninterrupted perioperative continuation of RAAS inhibitors.13 The guidelines provided by the European Society of Cardiology and European Society of Anaesthesiology also suggest the continuation of RAAS inhibitors throughout the perioperative period for patients with systolic heart failure but recommend transient discontinuation for patients with hypertension.14
This randomized study aimed to compare the effect of two practical strategies for preoperative ACEI management on the perioperative blood pressure of patients undergoing NCNV surgery. The two strategies studied were the omission of the final preoperative ACEI dose and the uninterrupted continuation of ACEI therapy. We hypothesized that patients randomized to ACEI omission would experience intraoperative hypotensive episodes less frequently than those randomized to ACEI continuation.
METHODS
Study Design and Setting
We performed a prospective randomized controlled trial (ClinicalTrials.gov: NCT01669434). The study was carried out in a preoperative evaluation clinic and its affiliated 489-bed academic medical center. Anesthesiologists and internal medicine physicians work collaboratively in the clinic to assess more than 5,000 patients annually (one-third of the institution’s elective surgeries). Patients were randomized 1:1 in block sizes of 5 and 10 and stratified by age < 65 and ≥ 65 years to the omission or continuation of the final preoperative ACEI dose (whether that dose was scheduled for the morning of surgery or the night prior). Preoperative clinicians enrolled patients and subsequently assigned them to intervention groups on the basis of a sequentially numbered list. Patients and healthcare providers were not blinded to allocation status. Intraoperative and postoperative management was provided in accordance with usual care as decided by treatment team.