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Preoperative Methylprednisolone Enhances Recovery After Endovascular Aortic Repair: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

de la Motte, Louise MD, PhD*; Kehlet, Henrik Prof. MD, PhD, FACS (Hon); Vogt, Katja MD, DMSc*; Nielsen, Claus H. MD, PhD; Groenvall, John B. MD§; Nielsen, Henning B. MD, DMSc; Andersen, Andreas*; Schroeder, Torben V. Prof. MD, DMSC; Lönn, Lars Prof. MD, PhD*,§

doi: 10.1097/SLA.0000000000000895
Papers of the 134th ASA Annual Meeting

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.

A single, preoperative high dose of methylprednisolone reduced the systemic inflammatory response syndrome and proinflammatory responses to elective endovascular repair of aortic aneurysms and consequently enhanced achievement of discharge criteria.

*Dept. of Vascular Surgery, Rigshospitalet, and University of Copenhagen, Copenhagen, Denmark

Section for Surgical Pathophysiology, Rigshospitalet, and University of Copenhagen, Copenhagen, Denmark

Institute for Inflammation Research, Dept. of Infectious Diseases and Rheumatology, Rigshospitalet, and University of Copenhagen, Copenhagen, Denmark

§Dept. of Cardiovascular Radiology, Rigshospitalet, and University of Copenhagen, Copenhagen, Denmark

Dept. of Anesthesiology, Rigshospitalet, and University of Copenhagen, Copenhagen, Denmark

Center for Clinical Education, Capital Region of Denmark, and University of Copenhagen, Copenhagen, Denmark.

Reprints: Louise de la Motte, MD, PhD, Dept. of Vascular Surgery, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark. E-mail: louise.de.la.motte@regionh.dk.

Disclosure: Supported by the Danish Heart Foundation, the Tove & John Girotti Foundation, the Aase & Ejnar Danielsens Foundation, Fonden til Lægevidenskabens Fremme (administered by the A.P. Møller Foundation), the Arvid Nilssons Foundation, the Toyota Foundation, the Overlæge Edgar Schnohr & Gilberte Schnohr's Foundation, and research funds from Copenhagen University Hospital, Rigshospitalet. The authors declare no conflicts of interest.

© 2014 by Lippincott Williams & Wilkins.