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Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol

Louisa J D van Dijk1,2, Jihan Harki3, Desirée van Noord3,4

  • 1Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands. l.vandijk@erasmusmc.nl.

Trials
|August 21, 2019
PubMed

Insights

The CoBaGI trial compares covered stents (CS) to bare-metal stents (BMS) for treating chronic mesenteric ischemia (CMI). This study aims to determine which stent type offers better long-term patency and patient outcomes in atherosclerotic CMI.

Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Gastroenterology

Background:

  • Chronic mesenteric ischemia (CMI) stems from reduced blood flow to the intestines, primarily due to atherosclerotic narrowing of mesenteric arteries.
  • Revascularization is crucial for managing CMI, preventing severe complications, and improving patient quality of life.
  • Endovascular therapy is now the preferred treatment for CMI, with ongoing research into optimal stent technologies.

Purpose of the Study:

  • To prospectively evaluate and compare the primary stent patency rates of covered stents (CS) versus bare-metal stents (BMS) in patients with atherosclerotic CMI.
  • To assess secondary endpoints including restenosis, symptom recurrence, re-intervention rates, quality of life, and cost-effectiveness.
  • To establish CS as a potentially superior option to BMS for treating CMI.

Main Methods:

  • The CoBaGI trial is a randomized, controlled, blinded, multicenter superiority trial involving 84 patients.
  • Participants are randomized 1:1 to receive either a balloon-expandable BMS or a balloon-expandable CS.
  • The primary endpoint is primary stent patency at 24 months, assessed via CT angiography.

Main Results:

  • The study is designed to provide definitive data on stent patency at 24 months.
  • Secondary analyses will examine patency at 6 and 12 months, alongside clinical outcomes.
  • Quality of life and cost-effectiveness will also be analyzed over the 24-month period.

Conclusions:

  • The CoBaGI trial is the first randomized controlled trial investigating CS versus BMS for CMI caused by atherosclerotic mesenteric stenosis.
  • Results will inform clinical practice regarding the optimal stent choice for CMI treatment.
  • The study will also offer insights into the impact of stenting on patient quality of life and its economic implications.
Abstract

Keywords:
AtherosclerosisBare-metal stentCeliac arteryChronic mesenteric ischemiaCovered stentEndovascular revascularizationSuperior mesenteric artery

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