Steroid Treatment to Prevent Thoracic Endovascular Aortic Repair Postimplantation Syndrome

NCT07328906 | Not Yet Recruiting DMC

• 1 other identifier: STOP TEVAR PIS
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Injury; MACE; Mortality; Postimplantation Syndrome

Keywords

postimplantation syndrome; methylprednisolone; TEVAR; myocardial injury; MACE; mortality

Outcome Measures

Primary Outcomes (1)

• Incidence of PIS

  Post-implantation syndrome would be defined as the occurrence of elevated body temperature (\>38.0°C), with the presence of leukocytosis (\>12,000/mm³), and an increase in the level of C-reactive protein (\>10g/L) during the first five days postoperatively, despite negative blood cultures.

  5 days postoperatively

Secondary Outcomes (6)

• incidence of myocardial injury

  first 3 days postoperatively

• incidence of MACE

  2 years postoperatively

• intensity of postoperative pain

  two days postoperatively

• degree of aortic remodeling

  one month and two years postoperatively

• 30-day mortality rate

  one month postoperatively

Other Outcomes (2)

• surgical complications

  30 days after TEVAR

• non-surgical complications

  30-days after TEVAR

Study Arms (2)

MP (experimental group)

EXPERIMENTAL

Intervention: methylprednisolone preoperatively 30 mg/kg. Patients in the MP group will receive 30 mg/kg of methylprednisolone, dissolved in 100 mL of saline, via a 30-minute slow intravenous infusion.

Drug: Methylprednisolone (MP)

Control group (placebo)

PLACEBO COMPARATOR

Patients randomized to the placebo group will receive 100 mL of physiological solution two hours prior to the intervention.

Drug: Placebo (saline)

Interventions

Placebo (saline) DRUG

Patients randomized to the placebo group would receive 100 mL of physiological solution two hours prior to the intervention.

Control group (placebo)

Methylprednisolone (MP) DRUG

Patients in the MP group would receive 30 mg/kg of methylprednisolone, dissolved in 100 mL of saline, via a 30-minute slow intravenous infusion.

MP (experimental group)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients admitted due to endovascular treatment of aortic dissection type B or thoracoabdominal aortic aneurysm in whom elective, open repair is planned.
• Patients capable of giving informed consent.
• Patients who are estimated to be available for long-term follow-up.

You may not qualify if:

• emergency procedures, the existence of severe renal insufficiency (serum creatinine \>176 µmol/L or estimated glomerular filtration rate \< 30 mL/min/1.73 m2), severe liver insufficiency (ALT value more than twice the upper limit or bilirubin levels more than twice the reference values), uncontrolled diabetes mellitus (fasting glycemia above 13.9 mmol/L, i.e. the value glycosylated hemoglobin over 8.5%), existence of active infection or sepsis, autoimmune disease, chronic pain syndromes, proven allergy to methylprednisolone, existence of gastric or duodenal ulcer, immunosuppressive or chemotherapy in the previous three months, active malignant disease, genetic diseases of connective tissue, pregnancy, critical lower limb ischemia, previous endovascular procedure on the aorta, preoperative administration of corticosteroids for any reason, significantly impaired cognitive status or psychiatric illness, acute peri/myocarditis, advanced heart failure, as well as voluntary refusal to participate in the study

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

Belgrade, Serbia

Location

Related Publications (16)

• 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.

  PMID: 22890468 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.

  PMID: 30165617 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.

  PMID: 32628988 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.

  PMID: 30521031 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.

  PMID: 38649128 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.

  PMID: 32339692 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.

  PMID: 38286152 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.

  PMID: 37965717 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.

  PMID: 25115430 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.

  PMID: 25935267 BACKGROUND

MeSH Terms

Interventions

Methylprednisolone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Igor Koncar, MD, Ph.D.

CONTACT

+381668300290; dr.koncar@gmail.com

Ksenija Jovanovic, MD, Ph.D.

CONTACT

+381668300966; ksenia.stevanovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgeon, MD, Ph.D.

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

SE (1)