PreOperative Methylprednisolone on Thoracic Endovascular Repair for Reducing Post-implantation Syndrome (POMTEVAR)

Summary

POMTEVAR trial is a multicenter, open-label and prospective random controlled study. Approximately 158 patients will be randomly allocated to thoracic endovascular repair (TEVAR) alone group or TEVAR plus methylprednisolone group and managed with respective treatment strategies. All study patients will be followed up in the outpatient clinic and undergo CT scans after 3 months from randomization. The primary objective is to test the hypothesis that PIS is lower in TEVAR plus methylprednisolone group than that in TEVAR alone group. The secondary objective is to test the hypothesis that changes of postoperative inflammatory indicators, incidence of postoperative acute renal failure and postoperative delirium, postoperative pain score are lower in TEVAR plus methylprednisolone group than that in TEVAR alone. In addition, 3-month all-cause death, 3-month major adverse cardiovascular events, 3-month aorta-related adverse events and 3-month aortic remodeling are compared between groups.

Timeline

Start

2022-05-01

Primary completion

2024-05-01

Completion

2024-10-01

Publications

• Background Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.
• Background Bossone E, LaBounty TM, Eagle KA. Acute aortic syndromes: diagnosis and management, an update. Eur Heart J. 2018 Mar 1;39(9):739-749d. doi: 10.1093/eurheartj/ehx319.
• Background Evangelista A, Isselbacher EM, Bossone E, Gleason TG, Eusanio MD, Sechtem U, Ehrlich MP, Trimarchi S, Braverman AC, Myrmel T, Harris KM, Hutchinson S, O'Gara P, Suzuki T, Nienaber CA, Eagle KA; IRAD Investigators. Insights From the International Registry of Acute Aortic Dissection: A 20-Year Experience of Collaborative Clinical Research. Circulation. 2018 Apr 24;137(17):1846-1860. doi: 10.1161/CIRCULATIONAHA.117.031264.
• Background Liu D, Luo H, Lin S, Zhao L, Qiao C. Comparison of the efficacy and safety of thoracic endovascular aortic repair with open surgical repair and optimal medical therapy for acute type B aortic dissection: A systematic review and meta-analysis. Int J Surg. 2020 Nov;83:53-61. doi: 10.1016/j.ijsu.2020.08.051. Epub 2020 Sep 11.
• Background Li FR, Wu X, Yuan J, Wang J, Mao C, Wu X. Comparison of thoracic endovascular aortic repair, open surgery and best medical treatment for type B aortic dissection: A meta-analysis. Int J Cardiol. 2018 Jan 1;250:240-246. doi: 10.1016/j.ijcard.2017.10.050. Epub 2017 Oct 16.
• Background De La Motte L, Vogt K, Panduro Jensen L, Groenvall J, Kehlet H, Veith Schroeder T, Lonn L. Incidence of systemic inflammatory response syndrome after endovascular aortic repair. J Cardiovasc Surg (Torino). 2011 Feb;52(1):73-9.
• 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 Arnaoutoglou E, Papas N, Milionis H, Kouvelos G, Koulouras V, Matsagkas MI. Post-implantation syndrome after endovascular repair of aortic aneurysms: need for postdischarge surveillance. Interact Cardiovasc Thorac Surg. 2010 Oct;11(4):449-54. doi: 10.1510/icvts.2010.242628. Epub 2010 Jul 19.
• Background Belkin N, Jackson BM, Foley PJ, Damrauer SM, Kalapatapu V, Golden MA, Fairman RM, Kelz RR, Wang GJ. Length of Stay after Thoracic Endovascular Aortic Repair Depends on Indication and Acuity. Ann Vasc Surg. 2019 Feb;55:157-165. doi: 10.1016/j.avsg.2018.06.027. Epub 2018 Sep 11.
• Background Chan TCW, Cheung CW, Wong SSC, Chung AYF, Irwin MG, Chan PK, Fu H, Yan CH, Chiu KY. Preoperative dexamethasone for pain relief after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1157-1167. doi: 10.1097/EJA.0000000000001372.
• 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 Nienaber CA, Clough RE, Sakalihasan N, Suzuki T, Gibbs R, Mussa F, Jenkins MP, Thompson MM, Evangelista A, Yeh JS, Cheshire N, Rosendahl U, Pepper J. Aortic dissection. Nat Rev Dis Primers. 2016 Jul 21;2:16053. doi: 10.1038/nrdp.2016.53.
• Background Czerny M, Schmidli J, Adler S, van den Berg JC, Bertoglio L, Carrel T, Chiesa R, Clough RE, Eberle B, Etz C, Grabenwoger M, Haulon S, Jakob H, Kari FA, Mestres CA, Pacini D, Resch T, Rylski B, Schoenhoff F, Shrestha M, von Tengg-Kobligk H, Tsagakis K, Wyss TR; EACTS/ESVS scientific document group. Current options and recommendations for the treatment of thoracic aortic pathologies involving the aortic arch: an expert consensus document of the European Association for Cardio-Thoracic surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):133-162. doi: 10.1093/ejcts/ezy313. No abstract available.
• Background Polderman JA, Farhang-Razi V, Van Dieren S, Kranke P, DeVries JH, Hollmann MW, Preckel B, Hermanides J. Adverse side effects of dexamethasone in surgical patients. Cochrane Database Syst Rev. 2018 Nov 23;11(11):CD011940. doi: 10.1002/14651858.CD011940.pub3.

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