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

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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.

          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.

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          Most cited references22

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          Evaluation of diagnostic tests when there is no gold standard. A review of methods.

          To generate a classification of methods to evaluate medical tests when there is no gold standard. Multiple search strategies were employed to obtain an overview of the different methods described in the literature, including searches of electronic databases, contacting experts for papers in personal archives, exploring databases from previous methodological projects and cross-checking of reference lists of useful papers already identified. All methods available were classified into four main groups. The first method group, impute or adjust for missing data on reference standard, needs careful attention to the pattern and fraction of missing values. The second group, correct imperfect reference standard, can be useful if there is reliable information about the degree of imperfection of the reference standard and about the correlation of the errors between the index test and the reference standard. The third group of methods, construct reference standard, have in common that they combine multiple test results to construct a reference standard outcome including deterministic predefined rules, consensus procedures and statistical modelling (latent class analysis). In the final group, validate index test results, the diagnostic test accuracy paradigm is abandoned and research examines, using a number of different methods, whether the results of an index test are meaningful in practice, for example by relating index test results to relevant other clinical characteristics and future clinical events. The majority of methods try to impute, adjust or construct a reference standard in an effort to obtain the familiar diagnostic accuracy statistics, such as sensitivity and specificity. In situations that deviate only marginally from the classical diagnostic accuracy paradigm, these are valuable methods. However, in situations where an acceptable reference standard does not exist, applying the concept of clinical test validation can provide a significant methodological advance. All methods summarised in this report need further development. Some methods, such as the construction of a reference standard using panel consensus methods and validation of tests outwith the accuracy paradigm, are particularly promising but are lacking in methodological research. These methods deserve particular attention in future research.
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            A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease.

            This trial was conducted to determine if covered stents offer a patency advantage over bare-metal stents in the treatment of aortoiliac arterial occlusive disease.
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              Durability of the balloon-expandable covered versus bare-metal stents in the Covered versus Balloon Expandable Stent Trial (COBEST) for the treatment of aortoiliac occlusive disease

              The Covered vs Balloon Expandable Stent Trial (COBEST) is the first multicenter trial to investigate the patency of covered stents (CSs) and bare-metal stents (BMSs) in the treatment of aortoiliac arterial disease. The short-term results demonstrated that CSs were superior to BMSs in maintaining patency for TransAtlantic Inter-Society Consensus (TASC) C and D lesions at 18 months and were equivalent to BMSs for TASC B lesions. The current study was conducted to determine if the initial patency advantage of CSs over BMSs was sustained at the 5-year follow-up.
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                Author and article information

                Contributors
                +31 10 704 0704 , l.vandijk@erasmusmc.nl
                +31 10 704 0704 , j.harki@erasmusmc.nl
                +31 10 461 6161 , D.Leemreis@franciscus.nl
                +31 10 704 0112 , h.verhagen@erasmusmc.nl
                +31 53 487 2410 , J.Kolkman@mst.nl
                +31 53 487 3442 , R.Geelkerken@mst.nl
                +31 10 704 0704 , m.bruno@erasmusmc.nl
                +31 10 703 2886 , a.moelker@erasmusmc.nl
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                20 August 2019
                20 August 2019
                2019
                : 20
                : 519
                Affiliations
                [1 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Gastroenterology and Hepatology, , Erasmus MC University Medical Center, ; ’s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands
                [2 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Radiology, , Erasmus MC University Medical Center, ; ’s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands
                [3 ]ISNI 0000 0004 0459 9858, GRID grid.461048.f, Department of Gastroenterology and Hepatology, , Franciscus Gasthuis and Vlietland, ; Kleiweg 500, 3045 PM Rotterdam, The Netherlands
                [4 ]ISNI 000000040459992X, GRID grid.5645.2, Department of Vascular Surgery, , Erasmus MC University Medical Center, ; ’s-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands
                [5 ]ISNI 0000 0004 0399 8347, GRID grid.415214.7, Department of Gastroenterology and Hepatology, , Medisch Spectrum Twente, ; Postbus 50 000, 7500 KA Enschede, The Netherlands
                [6 ]ISNI 0000 0000 9558 4598, GRID grid.4494.d, Department of Gastroenterology and Hepatology, , University Medical Center Groningen, ; Postbus 30.001, 9700 RB Groningen, The Netherlands
                [7 ]ISNI 0000 0004 0399 8347, GRID grid.415214.7, Department of Vascular Surgery, , Medisch Spectrum Twente, ; Postbus 50 000, 7500 KA Enschede, The Netherlands
                [8 ]ISNI 0000 0004 0399 8953, GRID grid.6214.1, TechMed Centre, Faculty Science and Technology, , University Twente, ; Postbus 50 000, 7500 KA Enschede, The Netherlands
                Author information
                http://orcid.org/0000-0002-6507-5666
                Article
                3609
                10.1186/s13063-019-3609-8
                6700968
                31429792
                5d5992b8-dc3e-46b7-8c9b-89dd0d7df1cc
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 21 October 2018
                : 23 July 2019
                Funding
                Funded by: Atrium Maquet Getinge Group
                Award ID: Unrestricted grant
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2019

                Medicine
                endovascular revascularization,bare-metal stent,covered stent,chronic mesenteric ischemia,atherosclerosis,celiac artery,superior mesenteric artery

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