Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial

Maura Marcucci, Thomas W Painter, David Conen, Vladimir Lomivorotov, Daniel I Sessler, Matthew T V Chan, Flavia K Borges, Kate Leslie, Emmanuelle Duceppe, María José Martínez-Zapata, Chew Yin Wang, Denis Xavier, Sandra N Ofori, Michael Ke Wang, Sergey Efremov, Giovanni Landoni, Ydo V Kleinlugtenbelt, Wojciech Szczeklik, Denis Schmartz, Amit X Garg, Timothy G Short, Maria Wittmann, Christian S Meyhoff, Mohammed Amir, David Torres, Ameen Patel, Kurt Ruetzler, Joel L Parlow, Vikas Tandon, Edith Fleischmann, Carisi A Polanczyk, Andre Lamy, Raja Jayaram, Sergey V Astrakov, William Ka Kei Wu, Chao Chia Cheong, Sabry Ayad, Mikhail Kirov, Miriam de Nadal, Valery V Likhvantsev, Pilar Paniagua, Hector J Aguado, Kamal Maheshwari, Richard P Whitlock, Michael H McGillion, Jessica Vincent, Ingrid Copland, Kumar Balasubramanian, Bruce M Biccard, Sadeesh Srinathan, Samandar Ismoilov, Shirley Pettit, David Stillo, Andrea Kurz, Emilie P Belley-Côté, Jessica Spence, William F McIntyre, Shrikant I Bangdiwala, Gordon Guyatt, Salim Yusuf, P J Devereaux; POISE-3 Trial Investigators and Study Groups

BACKGROUND

Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively.

METHODS

To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery.

DESIGN

Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723).

SETTING

110 hospitals in 22 countries.

PATIENTS

7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications.

INTERVENTION

In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery.

MEASUREMENTS

The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment.

RESULTS

The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term.

LIMITATION

Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels.

CONCLUSIONS

In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications.

PRIMARY FUNDING SOURCE

Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.