Department of Surgery & Cancer, Imperial College London, London, UK.
Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
Eur J Vasc Endovasc Surg. 2021 Jun;61(6):909-918. doi: 10.1016/j.ejvs.2021.02.009. Epub 2021 Mar 23.
To encompass the needs of all stakeholders and allow effective data synthesis from trials, registries, and other studies; a core outcome set for infrarenal abdominal aortic aneurysm (AAA) repair is needed. In this first stage, the aim was to report the range, frequency, and time of pre-specified outcomes reported following AAA repair.
Medline, Embase, and CENTRAL databases 2010 - 2019 were searched using ProQuest Dialog™.
The systematic review was reported to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA), PROSPERO registration CRD42019130119. Outcomes were coded using Core Outcome Measures in Effectiveness Trials (COMET) taxonomy and presented separately for intact and rupture repairs, endovascular aneurysm repair (EVAR) and open repair, and time from repair (acute < 90 days vs. ≥ 1 year) (COMET Initiative 1582).
For intact AAA and rupture repair, a total of 231 and 70 reports with 589 255 and 177 465 patients respectively were included: only 98 and 19 respectively provided ≥ 1 year outcomes. Most studies were retrospective, with 13 randomised trials of intact AAA repair and five randomised trials of ruptured AAA repair. For intact AAA, the most common pre-specified COMET taxonomy outcomes were mortality (181), vascular complications (137), and re-intervention (52). EVAR studies dominated the vascular outcomes in acute and later time periods: excluding 47 reports from device registries, reduced vascular outcomes to 83. For ruptured AAA, the three most common outcomes were mortality (64), vascular (11), and hospital stay (10). The range of outcomes reported was wide with functioning outcomes reported from most randomised trials but few retrospective studies.
This review identifies the paucity of long term data and the disproportionate attention paid to vascular complications vs. patient functioning outcomes, this skew being accentuated by reporting from EVAR device registries. These data will inform focus groups, prior to a pan-European Delphi consensus, involving clinicians, patients, carers and providers, for developing core outcomes for repair of intact and ruptured AAA.
为了满足所有利益相关者的需求，并允许对试验、登记处和其他研究进行有效的数据综合，需要制定一个用于肾下腹部主动脉瘤（AAA）修复的核心结局集。在第一阶段，目的是报告 AAA 修复后预先指定的结果的范围、频率和时间。
使用 ProQuest DialogTM 搜索了 Medline、Embase 和 CENTRAL 数据库 2010 年至 2019 年的数据。
该系统评价按照系统评价和荟萃分析报告的首选项目（PRISMA）以及 PROSPERO 注册 CRD42019130119 进行报告。使用有效性试验核心结局测量（COMET）分类法对结果进行编码，并分别为完整和破裂修复、血管内动脉瘤修复（EVAR）和开放修复以及修复后时间（急性 < 90 天与 ≥ 1 年）（COMET 倡议 1582）进行呈现。
对于完整的 AAA 和破裂修复，总共分别纳入了 231 份和 70 份报告，分别有 589 255 名和 177 465 名患者：只有 98 份和 19 份分别提供了 ≥ 1 年的结果。大多数研究为回顾性研究，其中有 13 项关于完整 AAA 修复的随机试验和 5 项关于破裂 AAA 修复的随机试验。对于完整的 AAA，最常见的预先指定的 COMET 分类法结果是死亡率（181）、血管并发症（137）和再干预（52）。EVAR 研究在急性和后期时间段主导了血管结局：排除 47 份来自设备登记处的报告后，血管结局减少到 83 个。对于破裂的 AAA，三个最常见的结果是死亡率（64）、血管（11）和住院时间（10）。报告的结果范围很广，大多数随机试验都报告了功能结局，但很少有回顾性研究报告。
本综述确定了缺乏长期数据和对血管并发症与患者功能结局的关注不成比例的问题，这种倾向因来自 EVAR 设备登记处的报告而加剧。这些数据将为涉及临床医生、患者、护理人员和提供者的泛欧德尔福共识前焦点小组提供信息，以便为完整和破裂的 AAA 修复制定核心结局。
