Columbo Jesse A, Kang Ravinder, Spangler Emily L, Newhall Karina, Brooke Benjamin S, Dosluoglu Hasan, Lee Eugene S, Raffetto Joseph D, Henke Peter K, Tang Gale S, Mureebe Leila, Kougias Panagoitis, Johanning Jason, Arya Shipra, Scali Salvatore T, Stone David H, Suckow Bjoern D, Orion Kristine, Halpern Vivienne, O'Connell Jessica, Inhat Daniel, Nelson Peter, Tzeng Edith, Zhou Wei, Barry Michael, Sirovich Brenda, Goodney Philip P
Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.
Department of Vascular Surgery, Birmingham VA Medical Center, Birmingham, AL.
Ann Vasc Surg. 2020 May;65:247-253. doi: 10.1016/j.avsg.2019.02.034. Epub 2019 May 8.
For patients with abdominal aortic aneurysm (AAA), randomized trials have found endovascular AAA repair (EVAR) is associated with lower perioperative morbidity and mortality than open surgical repair (OSR). However, OSR has fewer long-term aneurysm-related complications, such as endoleak or late rupture. Patients treated with EVAR and OSR have similar survival rates within two years after surgery, and OSR does not require intensive surveillance. Few have examined if patient preferences are aligned with the type of treatment they receive for their AAA. Although many assume that patients may universally prefer the less-invasive nature of EVAR, our preliminary work suggests that patients who value the lower risk of late complications may prefer OSR. In this study, called The PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) trial, we describe a cluster-randomized trial to test if a decision aid can better align patients' preferences and their treatment type for AAA. Patients enrolled in the study are candidates for either endovascular or open repair and are followed up at VA hospitals by vascular surgery teams who regularly perform both types of repair. In Aim 1, we will determine patients' preferences for endovascular or open repair and identify domains associated with each repair type. In Aim 2, we will assess alignment between patients' preferences and the repair type elected and then compare the impact of a decision aid on this alignment between the intervention and control groups. This study will help us to accomplish two goals. First, we will better understand the factors that affect patient preference when choosing between EVAR and OSR. Second, we will better understand if a decision aid can help patients be more likely to receive the treatment strategy they prefer for their AAA. Study enrollment began on June 1, 2017. Between June 1, 2017 and November 1, 2018, we have enrolled 178 of a total goal of 240 veterans from 20 VA medical centers and their vascular surgery teams across the country. We anticipate completing enrollment in PROVE-AAA in June 2019, and study analyses will be performed thereafter.
对于腹主动脉瘤（AAA）患者，随机试验发现，与开放手术修复（OSR）相比，血管内腹主动脉瘤修复术（EVAR）的围手术期发病率和死亡率更低。然而，OSR的长期动脉瘤相关并发症较少，如内漏或晚期破裂。接受EVAR和OSR治疗的患者在术后两年内的生存率相似，并且OSR不需要强化监测。很少有人研究患者的偏好是否与他们接受的AAA治疗类型一致。尽管许多人认为患者普遍会更喜欢EVAR的微创性质，但我们的初步研究表明，重视晚期并发症风险较低的患者可能更喜欢OSR。在这项名为“腹主动脉瘤开放与血管内修复的偏好（PROVE-AAA）试验”的研究中，我们描述了一项整群随机试验，以测试决策辅助工具是否能更好地使患者的偏好与他们接受的AAA治疗类型相匹配。参与该研究的患者是血管内修复或开放修复的候选者，并由定期进行这两种修复的血管外科团队在退伍军人事务部（VA）医院进行随访。在目标1中，我们将确定患者对血管内修复或开放修复的偏好，并确定与每种修复类型相关的领域。在目标2中，我们将评估患者的偏好与所选修复类型之间的匹配度，然后比较决策辅助工具对干预组和对照组之间这种匹配度的影响。这项研究将帮助我们实现两个目标。首先，我们将更好地了解在EVAR和OSR之间做出选择时影响患者偏好的因素。其次，我们将更好地了解决策辅助工具是否能帮助患者更有可能接受他们为AAA所偏好的治疗策略。研究招募于2017年6月1日开始。在2017年6月1日至2018年11月1日期间，我们已经从全国20个VA医疗中心及其血管外科团队招募了240名退伍军人中的178名，目标总数为240名。我们预计在2019年6月完成PROVE-AAA的招募工作，之后将进行研究分析。
