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

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. Trial registration ClinicalTrials.gov, ID: NCT02428582 . Registered on 29 April 2015. Electronic supplementary material The online version of this article (10.1186/s13063-019-3609-8) contains supplementary material, which is available to authorized users.

European guidelines on chronic mesenteric ischaemia – joint United European Gastroenterology, European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Gastrointestinal and Abdominal Radiology, Netherlands Association of Hepatogastroenterologists, Hellenic Society of Gastroenterology, Cardiovascular and Interventional Radiological Society of Europe, and Dutch Mesenteric Ischemia Study group clinical guidelines on the diagnosis and treatment of patients with chronic mesenteric

“…The results of a randomised controlled trial (NCT02428582) comparing the CS and BMS are awaited. 107 Comparative data on PMAS with a drugeluting stent (DES) is not available in the literature.…”

“…A randomised controlled trial comparing the BMS and CS is currently underway and results are expected in 2021. 107 However, questions concerning the role of the DES in the mesenteric arteries and the optimal revascularization strategy in patients with an in-stent stenosis remain unanswered. Development of validated software tools for accurate grading of in-stent stenosis on CTA, using the transstenotic mean arterial pressure gradient under angiography as a reference, is another important research topic.…”

Chronic mesenteric ischemia: Clinical practice guidelines from the Society for Vascular Surgery

“…Similarly, they reported that the freedom from restenosis (89 6 10% vs 49 6 14%; P < .04), freedom from symptom recurrence (100% vs 64 6 9%; P ¼ .001), and freedom from reintervention (100% vs 72 6 9%; P ¼ .03) were all better for the covered stents in the reintervention group. Notably, van Dijk et al 130 have published the study protocol for a randomized trial (CoBaGI) comparing balloonexpandable covered vs balloon-expandable bare-metal stents for CMI.…”

Endovascular Pressure Measurements to Assess the Functional Severity of Mesenteric Arterial Stenoses

“…Technical success was achieved in 89.5% of 38 revascularizations. Stent specifications could not be assessed because 19 of the 38 (50%) revascularization procedures were included in an ongoing double blinded randomized controlled trial, comparing the patency of bare metal stents (Palmaz Blue; Cordis, Baar, Switzerland) with the patency of covered stents (V12, Atrium Medical Corporation, Merrimack, NH) (13).…”