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. 2020 May:65:247-253.
doi: 10.1016/j.avsg.2019.02.034. Epub 2019 May 8.

Design of the PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Trial

Jesse A Columbo  1 , Ravinder Kang  1 , Emily L Spangler  2 , Karina Newhall  1 , Benjamin S Brooke  3 , Hasan Dosluoglu  4 , Eugene S Lee  5 , Joseph D Raffetto  6 , Peter K Henke  7 , Gale S Tang  8 , Leila Mureebe  9 , Panagoitis Kougias  10 , Jason Johanning  11 , Shipra Arya  12 , Salvatore T Scali  13 , David H Stone  1 , Bjoern D Suckow  1 , Kristine Orion  14 , Vivienne Halpern  15 , Jessica O'Connell  16 , Daniel Inhat  17 , Peter Nelson  18 , Edith Tzeng  19 , Wei Zhou  20 , Michael Barry  21 , Brenda Sirovich  1 , Philip P Goodney  22 ; PROVE-AAA Study Team
Collaborators, Affiliations

Design of the PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Trial

Jesse A Columbo et al. Ann Vasc Surg. 2020 May.

Abstract

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.

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Figures

Figure 1:
Figure 1:
Conceptual model for our study of preferences for abdominal aortic aneurysm repair type
Figure 2:
Figure 2:
Study design for our study of preferences for abdominal aortic aneurysm repair type.
Figure 3:
Figure 3:
Study sites for the PROVE-AAA study.
See this image and copyright information in PMC

References

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