Vascular Surgery, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.
Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool, UK.
BMJ Open. 2021 Nov 30;11(11):e054493. doi: 10.1136/bmjopen-2021-054493.
In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?'
UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.
The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.
ISRCTN85731188.
在所有腹主动脉瘤（AAA）中，有三分之一的瘤颈较短（肾下型）或存在其他不利的解剖学特征，使得手术更加复杂、危险和昂贵。手术选择包括开放手术修复和血管内修复（EVAR）技术，包括分支型 EVAR、带附加物的 EVAR（烟囱/内支架）和超适应证标准 EVAR。英国复杂型动脉瘤研究（UK-COMPASS）的目的是回答由英国国家卫生与保健优化研究所卫生技术评估（NIHR HTA）计划提出的研究问题：“对于肾下型 AAA 的管理策略，包括分支型血管内修复，其临床和成本效益如何？”
UK-COMPASS 是一项队列研究，比较了不同策略治疗复杂型 AAA 的临床和成本效益，策略的分层因素包括生理适应性和解剖复杂性，并对基线风险和适应证偏倚进行了统计学校正。研究有两个数据流。首先，从医院病例统计和国家血管登记处（NVR）获取常规收集的数据。对 2017 年 11 月 1 日至 2019 年 10 月 31 日期间在英格兰接受择期 AAA 修复手术的所有患者的术前 CT 扫描进行 Corelab 分析，以准确识别和纳入所有治疗的复杂动脉瘤。其次，从英格兰各研究点获取关于生活质量和治疗成本的报告数据。研究点招募还包括直径大于 55 毫米的复杂动脉瘤患者，这些患者的手术被推迟（采用药物治疗）。主要观察指标是围手术期全因死亡率。随访中位数为 5 年。
该研究已获得伦理委员会、保密咨询小组和卫生研究管理局的全面监管批准。与国民保健制度数字服务部和 NVR 签订了数据共享协议。传播将通过 NIHR HTA 报告、同行评议期刊和会议进行。
ISRCTN85731188。
