Comparison of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Management Strategies Before Cardiac Surgery: A Pilot Randomized Controlled Registry Trial

Sean van Diepen, Colleen M Norris, Yinggan Zheng, Jayan Nagendran, Michelle M Graham, Damaris Gaete Ortega, Derek R Townsend, Justin A Ezekowitz, Sean M Bagshaw, Sean van Diepen, Colleen M Norris, Yinggan Zheng, Jayan Nagendran, Michelle M Graham, Damaris Gaete Ortega, Derek R Townsend, Justin A Ezekowitz, Sean M Bagshaw

Abstract

Background Postoperative clinical outcomes associated with the preoperative continuation or discontinuation of angiotensin-converting enzyme inhibitors ( ACEIs ) or angiotensin receptor blockers ( ARBs ) before cardiac surgery remain unclear. Methods and Results In a single-center, open-label, randomized, registry-based clinical trial, patients undergoing nonemergent cardiac surgery were assigned to ACEI / ARB continuation or discontinuation 2 days before surgery. Among the 584 patients screened, 261 met study criteria and 126 (48.3%) patients were enrolled. In total,121 patients (96% adherence; 60 to continuation and 61 to ACEI / ARB discontinuation) underwent surgery and completed the study protocol, and follow-up was 100% complete. Postoperative intravenous vasopressor use (78.3% versus 75.4%, P=0.703), vasodilator use (71.7% versus 80.3%, P=0.265), vasoplegic shock (31.7% versus 27.9%, P=0.648), median duration of vasopressor (10 versus 5 hours, P=0.494), and vasodilator requirements (10 versus 9 hours, P=0.469) were not significantly different between the continuation and discontinuation arms. No differences were observed in the incidence of acute kidney injury (1.7% versus 1.6%, P=0.991), stroke (no events, mortality (1.7% versus 1.6%, P=0.991), median duration of mechanical ventilation (6 versus 6 hours, P=0.680), and median intensive care unit length of stay (43 versus 27 hours, P=0.420) between the treatment arms. Conclusions A randomized study evaluating the routine continuation or discontinuation of ACEIs or ARB s before cardiac surgery was feasible, and treatment assignment was not associated with differences in postoperative physiological or clinical outcomes. These preliminary findings suggest that preoperative ACEI / ARB management strategies did not affect the postoperative course of patients undergoing cardiac surgery. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifier: NCT 02096406.

Trial registration: ClinicalTrials.gov NCT02096406.

Keywords: angiotensin receptor blocker; angiotensin‐converting enzyme inhibitor; cardiac surgery; vasoplegia.

Figures

Figure 1
Figure 1
Study cohort diagram. ACEI indicates angiotensin‐converting enzyme inhibitor; ARB, angiotensin receptor blocker; CABG, coronary artery bypass grafting; mITT, modified intention to treat.
Figure 2
Figure 2
Incidence of postoperative inopressor requirement, intravenous vasodilatory use, and vasoplegic shock by randomized treatment assignment. Error bars are 95% confidence intervals of point estimates. ACE indicates angiotensin‐converting enzyme inhibitor; ARB, angiotensin receptor blocker.

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