Eslami Mohammad H, Doros Gheorghe, Goodney Philip P, Elderup-Jorgenson Jens, Cronenwett Jack L, Malikova Marina, Farber Alik
Division of Vascular and Endovascular Surgery, Boston University School of Medicine, Boston, MA.
Department of Biostatistics, Boston University School of Public Health, Boston, MA.
Ann Vasc Surg. 2015 Feb;29(2):278-85. doi: 10.1016/j.avsg.2014.08.007. Epub 2014 Oct 12.
We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters' prospective trials on very modest budget.
VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event-free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform.
Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates.
我们描述了一项前瞻性、随机、多中心试验的组织情况，该试验比较开放性腘动脉动脉瘤修复术（OPAR）和血管腔内腘动脉动脉瘤修复术（EPAR）治疗无症状腘动脉动脉瘤（PAA）的有效性，以此作为如何使用血管质量倡议（VQI）框架的一个示例。鉴于许多中心都参与了VQI，该模型可用于在预算非常有限的情况下开展多中心前瞻性试验。
VQI前瞻性收集多种血管手术的数据。这些数据包括许多关于患者及其手术的重要围手术期、术中及术后细节。我们描述了一项研究，参与中心只需对所收集的数据进行最小程度的改动，就能为一个重要的临床问题提供一级证据。数据将使用经过修改的VQI表格在现有的VQI数据报告结构内进行收集。我们计划将148例无症状PAA患者纳入开放手术组和血管腔内手术组。来自参与VQI中心的患者将按1:1随机分配接受OPAR或EPAR治疗，并将平均随访2.5年。我们的主要假设是，EPAR组的主要肢体不良事件无进展生存率较低，且EPAR与更多的二次干预、改善的生活质量及缩短的住院时间相关。本试验的预算在研究期间固定为每年10,000美元，由于VQI平台的功能，该试验被认为是可行的。
利用现有的VQI基础设施，腘动脉动脉瘤开放与血管腔内修复术将在预算有限的情况下为PAA治疗提供一级数据。拟议的试验具有设计合理的对比性，将使用客观的性能目标来描述肢体相关的发病率和手术再干预率。
