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

VL - 260

SP - 540

EP - 549

JO - Advances in Surgery

JF - Advances in Surgery

SN - 0003-4932

IS - 3

ER -