覆膜支架与裸金属支架治疗慢性动脉粥样硬化性胃肠道缺血（CoBaGI）的随机对照试验研究方案。
Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial.
机构信息
Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
Department of Radiology, Erasmus MC University Medical Center, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands.
出版信息
Trials. 2019 Aug 20;20(1):519. doi: 10.1186/s13063-019-3609-8.
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.
背景
慢性肠系膜缺血（CMI）是胃肠道血液供应不足的结果，>90%的病例是由肠系膜动脉的动脉粥样硬化性狭窄引起的。血管重建治疗适用于诊断为动脉粥样硬化性 CMI 的患者，以缓解症状并预防与高发病率和死亡率相关的慢性肠系膜缺血急性发作。腔内治疗迅速发展，已取代手术成为 CMI 的首选治疗方法。目前，裸金属支架（BMS）是标准治疗方法，尽管回顾性研究表明，覆膜支架（CS）的通畅率明显更高。在慢性动脉粥样硬化性胃肠道缺血（CoBaGI）试验中，比较覆膜支架和裸金属支架旨在前瞻性评估 CS 与 BMS 在动脉粥样硬化性 CMI 患者中的通畅率。
方法/设计：CoBaGI 试验是一项在荷兰肠系膜缺血研究组（DMIS）的六个中心进行的随机对照、平行组、患者和研究者设盲、优效性、多中心试验。84 例经共识诊断为动脉粥样硬化性 CMI 的患者按 1:1 随机分为球囊扩张型 BMS（Palmaz Blue 带快速交换输送系统，Cordis 公司，Bridgewater，NJ，美国）或球囊扩张型 CS（Advanta V12 经导丝，Atrium Maquet Getinge Group，Hudson，NH，美国）。主要终点是 24 个月时 CT 血管造影评估的主要支架通畅率。次要终点是 6 个月和 12 个月时的主要支架通畅率和次要通畅率、无再狭窄率、无症状复发率、无再介入率、根据 EQ-5D-5L 和 SF-36 评估的生活质量以及 6、12 和 24 个月时的成本效益。
讨论
CoBaGI 试验旨在评估 CS 与 BMS 在治疗由动脉粥样硬化性肠系膜狭窄引起的 CMI 患者中的通畅率。此外，CoBaGI 试验应该能够提供这些患者在支架置入前后的生活质量及其成本效益方面的见解。CoBaGI 试验是首个在由动脉粥样硬化性肠系膜动脉狭窄引起的 CMI 患者中进行的随机对照试验。
试验注册
ClinicalTrials.gov，ID：NCT02428582。注册于 2015 年 4 月 29 日。
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