Steroid Treatment to Prevent Thoracic Endovascular Aortic Repair Postimplantation Syndrome

Summary

Postimplantation syndrome (PIS) is a common and clinically important complication following thoracic endovascular aortic repair (TEVAR). PIS is characterized by a strong systemic inflammatory response to the stent-graft implantation and is manifested by flu-like symptoms, which include fever, increased white blood count, increased levels of acute phase proteins, and fatigue, but without a clear inflammatory and infective cause. Besides, it has been demonstrated that PIS is associated with prolonged hospital stay and increased risk for postoperative complications, including acute kidney injury, postoperative delirium, and increased postoperative pain scores. Recently, there has been increasing evidence that PIS is associated with an increased risk of major adverse cardiac events (MACE) and perioperative myocardial injury. Observational studies suggest that preoperative administration of glucocorticoids may decrease the incidence of PIS after TEVAR and EVAR procedures. However, to date, there are no randomised trials that have investigated whether preoperative administration of glucocorticoids can reduce the incidence of PIS and its associated poorer treatment outcomes following TEVAR. This randomized controlled trial was designed to investigate the effect of glucocorticoid administration on reducing the incidence and improving the outcome of patients who develop PIS after TEVAR.

Timeline

Start

2026-01

Primary completion

2027-01

Completion

2029-01

Publications

• Background 16. American Psychiatric Association. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders. 2013;5th ed. Arlington, VA.
• Background Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
• Background Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
• Background Upchurch GR Jr, Escobar GA, Azizzadeh A, Beck AW, Conrad MF, Matsumura JS, Murad MH, Perry RJ, Singh MJ, Veeraswamy RK, Wang GJ. Society for Vascular Surgery clinical practice guidelines of thoracic endovascular aortic repair for descending thoracic aortic aneurysms. J Vasc Surg. 2021 Jan;73(1S):55S-83S. doi: 10.1016/j.jvs.2020.05.076. Epub 2020 Jul 3.
• Background Zhu Y, Luo S, Ding H, Liu Y, Huang W, Xie N, Li J, Xue L, Luo J. Predictors associated with an increased prevalence of postimplantation syndrome after thoracic endovascular aortic repair for type B aortic dissectiondagger. Eur J Cardiothorac Surg. 2019 May 1;55(5):998-1005. doi: 10.1093/ejcts/ezy379.
• Background 11. Dworak T, Mäurer L, Kolbenschlag J, Bockler D, Kotelis D. Preoperative corticosteroids in EVAR and TEVAR - is there an impact on postimplantation syndrome? Vascular. 2020;28(6):648-654.
• Background 10. Becquemin JP, Kelly P, Zubilewicz T, Desgranges P, Allaire E, Kobeiter H. Postimplantation syndrome after endovascular aneurysm repair: incidence, predictive factors, and outcome. Eur J Vasc Endovasc Surg. 2003;25(2):139-145.
• Background 9. Kobayashi K, Sato M, Inoue M, Shibata Y, Asai Y. Steroid pretreatment attenuates the systemic inflammatory response after endovascular aneurysm repair. J Vasc Surg. 2015;61(1):127-134.
• Background 8. Soares Ferreira R, Bastos Gonçalves F. Postimplantation syndrome after endovascular aneurysm repair. In: Koncar I, editor. Abdominal Aortic Aneurysm - From Basic Research to Clinical Practice. IntechOpen; 2018.
• Background Mannina C, Kini A, Carbone A, Neibart E, Bossone E, Prandi FR, Tadros R, Esposito G, Erbel R, Sharma SK, Lerakis S. Management of Systemic Inflammatory Response Syndrome After Cardiovascular Interventions. Diagnostic, Prognostic, and Therapeutic Implications. Am J Cardiol. 2024 Jun 15;221:84-93. doi: 10.1016/j.amjcard.2024.04.007. Epub 2024 Apr 20.
• Background Sousa J, Vilares AT. Postimplantation Syndrome Is Not Associated with Myocardial Injury after Noncardiac Surgery after Endovascular Aneurysm Repair. Ann Vasc Surg. 2020 Oct;68:275-282. doi: 10.1016/j.avsg.2020.04.014. Epub 2020 Apr 25.
• Background 5. Lee S, Kim H, Park J, Moon JY, Yang JH, Chung J, et al. Risk prediction and prognostic analysis of post-implantation syndrome after thoracic endovascular aortic repair. J Endovasc Ther. 2023;30(4):536-43.
• Background Wu Q, He J, Li H, Xie L, Zeng W, Lin X, Qiu Z, Chen L. Outcomes of post-implantation syndrome after endovascular repair for Stanford type B aortic dissection. J Vasc Surg. 2024 Jun;79(6):1326-1338. doi: 10.1016/j.jvs.2024.01.200. Epub 2024 Jan 28.
• Background Wang B, Miao M, Shi Q, Xian H, Cao Y, Wang X. Impact of post-implantation syndrome on outcomes in acute type B aortic syndrome patients undergoing endovascular repair. Vasa. 2024 Jan;53(1):53-60. doi: 10.1024/0301-1526/a001102. Epub 2023 Nov 15.
• Background de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lonn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895.
• Background Melissano G, Tshomba Y, Rinaldi E, Chiesa R. Initial clinical experience with a new low-profile thoracic endograft. J Vasc Surg. 2015 Aug;62(2):336-42. doi: 10.1016/j.jvs.2015.02.049. Epub 2015 Apr 30.

Drugs

Indications

No indication recorded.