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