Abstract
BackgroundChronic 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/designThe 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.DiscussionThe 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.Trial registrationClinicalTrials.gov, ID: NCT02428582. Registered on 29 April 2015.
Highlights
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
The CoBaGI trial is designed to assess the patency rates of covered stents (CS) versus Bare-metal stents (BMS) in patients treated for CMI caused by atherosclerotic mesenteric stenosis
The CoBaGI trial is the first randomized controlled trial performed in CMI caused by atherosclerotic mesenteric artery stenosis
Summary
The CoBaGI trial is designed to compare the patency rate of BMS (standard care) with CS in patients with CMI based on atherosclerotic mesenteric stenosis. The CoBaGI trial is the first randomized controlled trial to compare BMS with CS in patients with CMI based on an atherosclerotic mesenteric stenosis. A pivotal inclusion criterion for the CoBaGI trial is a consensus diagnosis of CMI based on atherosclerotic mesenteric artery stenosis which is established in a multidisciplinary meeting joined by gastroenterologists, interventional radiologists and vascular surgeons. The CoBaGI trial is a multicenter, randomized controlled, patient- and investigator-blinded superiority trial comparing BMS (standard of care) with CS in patients with CMI caused by an atherosclerotic stenosis at the origin of the mesenteric artery.
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