TY - JOUR
T1 - Covered stents versus Bare-metal stents in c hronic atherosclerotic Gastrointestinal Ischemia (CoBaGI)
T2 - study protocol for a randomized controlled trial
AU - van Dijk, Louisa J. D.
AU - Harki, Jihan
AU - van Noord, Desiree
AU - Verhagen, Hence J. M.
AU - Kolkman, Jeroen J.
AU - Geelkerken, Robert H.
AU - Bruno, Marco J.
AU - Moelker, Adriaan
AU - Balm, Ron
AU - de Borst, Gert Jan
AU - Blauw, Juliette T.
AU - Bakker, Olaf J.
AU - Buscher, Hessel C. J. L.
AU - Fioole, Bram
AU - Hamming, Jaap F.
AU - van den Heuvel, Daniel A. F.
AU - van Hattum, Eline S.
AU - Hinnen, Jan Willem
AU - van der Laan, Maarten J.
AU - Lenaerts, Kaatje
AU - van Noord, Desiree
AU - Peppelenbosch, Maikel P.
AU - van Petersen, Andre S.
AU - Rijnja, Pepijn
AU - van der Schaar, Peter J.
AU - Terlouw, Luke G.
AU - de Vries, Jean Paul P. M.
AU - Vroegindeweij, Dammis
AU - Dutch Mesenteric Ischemia Study group (DMIS)
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/8/20
Y1 - 2019/8/20
N2 - 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.
AB - 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.
KW - Endovascular revascularization
KW - Bare-metal stent
KW - Covered stent
KW - Chronic mesenteric ischemia
KW - Atherosclerosis
KW - Celiac artery
KW - Superior mesenteric artery
KW - CHRONIC MESENTERIC ISCHEMIA
KW - HEALTH SURVEY
KW - MANAGEMENT
KW - ARTERY
KW - TONOMETRY
KW - DIAGNOSIS
KW - SF-36
U2 - 10.1186/s13063-019-3609-8
DO - 10.1186/s13063-019-3609-8
M3 - Article
C2 - 31429792
SN - 1745-6215
VL - 20
JO - Trials
JF - Trials
IS - 1
M1 - 519
ER -