Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial.

Abstract:

OBJECTIVE:To evaluate effects of preoperative high-dose glucocorticoid on the inflammatory response and recovery after endovascular aortic aneurysm repair (EVAR). BACKGROUND:The postimplantation syndrome after EVAR may delay recovery due to the release of proinflammatory mediators. Glucocorticoids may reduce postoperative inflammatory responses and enhance recovery, but with limited information on EVAR. METHODS:A single-center, randomized, double-blind, placebo-controlled trial of 153 patients undergoing elective EVAR between November 2009 and January 2013. Patients received 30 mg/kg of methylprednisolone (MP) (n = 77) or placebo (n = 76) preoperatively. Primary outcome was a modified version of the systemic inflammatory response syndrome. Secondary outcome measures were the effect on inflammatory biomarkers, morbidity, and time to meet discharge criteria. RESULTS:Of 153 randomized patients, 150 (98%) were evaluated for the primary outcome. MP reduced systemic inflammatory response syndrome from 92% to 27% (P < 0.0001) (number needed to treat = 1.5), maximal plasma interleukin 6 from 186 pg/mL [interquartile range (IQR) = 113-261 pg/mL] to 20 pg/mL (IQR = 11-28 pg/mL) (P < 0.001) and fulfillment of discharge criteria was shorter [2 days (IQR = 2-4 days) vs 3 days (IQR = 3-4 days)] (P < 0.001). C-reactive protein, temperature, interleukin 8, and soluble tumor necrosis factor receptor were also reduced (P < 0.001) by MP. Myeloperoxidase, D-dimer, and matrix metalloproteinase 9 were not modified. No differences in 30-day medical (23% vs 36%) (P = 0.1) or surgical (20% vs 21%) morbidity were found in the active group versus the placebo group. CONCLUSIONS:Preoperative MP attenuates the inflammatory response with a faster recovery after EVAR for abdominal aortic aneurysms. Further safety and dose-response studies are required to allow recommendations for general practice. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00989729.

journal_name

Ann Surg

journal_title

Annals of surgery

authors

de la Motte L,Kehlet H,Vogt K,Nielsen CH,Groenvall JB,Nielsen HB,Andersen A,Schroeder TV,Lönn L

doi

10.1097/SLA.0000000000000895

subject

Has Abstract

pub_date

2014-09-01 00:00:00

pages

540-8; discussion 548-9

issue

3

eissn

0003-4932

issn

1528-1140

pii

00000658-201409000-00015

journal_volume

260

pub_type

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