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

TY - JOUR

T1 - Preoperative methylprednisolone enhances recovery after endovascular aortic repair

T2 - a randomized, double-blind, placebo-controlled clinical trial

AU - de la Motte, Louise

AU - Kehlet, Henrik

AU - Vogt, Katja

AU - Nielsen, Claus H

AU - Groenvall, John B

AU - Nielsen, Henning B

AU - Andersen, Andreas

AU - Schroeder, Torben V

AU - Lönn, Lars

PY - 2014/9

Y1 - 2014/9

N2 - 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.

AB - 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.

KW - Aged

KW - Aortic Aneurysm, Abdominal

KW - Area Under Curve

KW - Blood Vessel Prosthesis Implantation

KW - Double-Blind Method

KW - Endovascular Procedures

KW - Female

KW - Glucocorticoids

KW - Humans

KW - Interleukins

KW - Length of Stay

KW - Male

KW - Methylprednisolone

KW - Postoperative Complications

KW - Preoperative Period

KW - Systemic Inflammatory Response Syndrome

KW - Treatment Outcome

U2 - 10.1097/SLA.0000000000000895

DO - 10.1097/SLA.0000000000000895

M3 - Journal article

C2 - 25115430

SN - 0003-4932

VL - 260

SP - 540

EP - 549

JO - Advances in Surgery

JF - Advances in Surgery

IS - 3

ER -