title: 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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00989729.
authors.affiliation: *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.
authors.forename: Louise
authors.initials: L
authors.lastname: de la Motte
authors.forename: Henrik
authors.initials: H
authors.lastname: Kehlet
authors.forename: Katja
authors.initials: K
authors.lastname: Vogt
authors.forename: Claus H
authors.initials: CH
authors.lastname: Nielsen
authors.forename: John B
authors.initials: JB
authors.lastname: Groenvall
authors.forename: Henning B
authors.initials: HB
authors.lastname: Nielsen
authors.forename: Andreas
authors.initials: A
authors.lastname: Andersen
authors.forename: Torben V
authors.initials: TV
authors.lastname: Schroeder
authors.forename: Lars
authors.initials: L
authors.lastname: Lönn
mesh_terms: D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000601:surgery*; D019540:Area Under Curve; D019917:Blood Vessel Prosthesis Implantation; D004311:Double-Blind Method; D057510:Endovascular Procedures; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007378:Interleukins / Q000097:blood; D007902:Length of Stay; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D057234:Preoperative Period; D018746:Systemic Inflammatory Response Syndrome / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D007378:Interleukins; D008775:Methylprednisolone