Covered stents versus Bare-metal stents in c hronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial

Louisa J. D. van Dijk*, Jihan Harki, Desiree van Noord, Hence J. M. Verhagen, Jeroen J. Kolkman, Robert H. Geelkerken, Marco J. Bruno, Adriaan Moelker, Ron Balm, Gert Jan de Borst, Juliette T. Blauw, Olaf J. Bakker, Hessel C. J. L. Buscher, Bram Fioole, Jaap F. Hamming, Daniel A. F. van den Heuvel, Eline S. van Hattum, Jan Willem Hinnen, Maarten J. van der Laan, Kaatje LenaertsDesiree van Noord, Maikel P. Peppelenbosch, Andre S. van Petersen, Pepijn Rijnja, Peter J. van der Schaar, Luke G. Terlouw, Jean Paul P. M. de Vries, Dammis Vroegindeweij, Dutch Mesenteric Ischemia Study group (DMIS)

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background: Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the first choice of treatment in CMI. Bare-metal stents (BMS) are standard care currently, although retrospective studies suggested significantly higher patency rates for covered stents (CS). The Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI) trial is designed to prospectively assess the patency of CS versus BMS in patients with atherosclerotic CMI.

Methods/design: The CoBaGI trial is a randomized controlled, parallel-group, patient-and investigator-blinded, superiority, multicenter trial conducted in six centers of the Dutch Mesenteric Ischemia Study group (DMIS). Eighty-four patients with a consensus diagnosis of atherosclerotic CMI are 1:1 randomized to either a balloon-expandable BMS (Palmaz Blue with rapid-exchange delivery system, Cordis Corporation, Bridgewater, NJ, USA) or a balloon-expandable CS (Advanta V12 over-the-wire, Atrium Maquet Getinge Group, Hudson, NH, USA). The primary endpoint is the primary stent-patency rate at 24 months assessed with CT angiography. Secondary endpoints are primary stent patency at 6 and 12 months and secondary patency rates, freedom from restenosis, freedom from symptom recurrence, freedom from re-intervention, quality of life according the EQ-5D-5 L and SF-36 and cost-effectiveness at 6, 12 and 24 months.

Discussion: The CoBaGI trial is designed to assess the patency rates of CS versus BMS in patients treated for CMI caused by atherosclerotic mesenteric stenosis. Furthermore, the CoBaGI trial should provide insights in the quality of life of these patients before and after stenting and its cost-effectiveness. The CoBaGI trial is the first randomized controlled trial performed in CMI caused by atherosclerotic mesenteric artery stenosis.

Original languageEnglish
Article number519
Number of pages9
JournalTrials
Volume20
Issue number1
DOIs
Publication statusPublished - 20 Aug 2019

Keywords

  • Endovascular revascularization
  • Bare-metal stent
  • Covered stent
  • Chronic mesenteric ischemia
  • Atherosclerosis
  • Celiac artery
  • Superior mesenteric artery
  • CHRONIC MESENTERIC ISCHEMIA
  • HEALTH SURVEY
  • MANAGEMENT
  • ARTERY
  • TONOMETRY
  • DIAGNOSIS
  • SF-36

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