TY - JOUR
T1 - Design of the PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Trial
AU - The PROVE-AAA Study Team
AU - Columbo, Jesse A.
AU - Kang, Ravinder
AU - Spangler, Emily L.
AU - Newhall, Karina
AU - Brooke, Benjamin S.
AU - Dosluoglu, Hasan
AU - Lee, Eugene S.
AU - Raffetto, Joseph D.
AU - Henke, Peter K.
AU - Tang, Gale S.
AU - Mureebe, Leila
AU - Kougias, Panagoitis
AU - Johanning, Jason
AU - Arya, Shipra
AU - Scali, Salvatore T.
AU - Stone, David H.
AU - Suckow, Bjoern D.
AU - Orion, Kristine
AU - Halpern, Vivienne
AU - O'Connell, Jessica
AU - Inhat, Daniel
AU - Nelson, Peter
AU - Tzeng, Edith
AU - Zhou, Wei
AU - Barry, Michael
AU - Sirovich, Brenda
AU - Goodney, Philip P.
AU - Gaudette, Cory
AU - Grippa, Francisco
AU - Voorhees, Amy
AU - Moore, Kayla
AU - Dowse, Catherine
AU - Barbey, Sarah
AU - Galla, Ann
AU - Grove, Lori
AU - Belanger, Karen
AU - Karamoto, Angela
AU - Patel, Veep
AU - Bigda, Susan
AU - Jabori, Sinan
AU - Chun, Kevin
AU - Beckstrom, Julie
AU - Maloney, Maria
AU - Schieber, Molly
AU - Zoble, Adam
AU - Anderson, Stephanie
AU - Morrison, Michael
N1 - Funding Information:
The authors also wish to acknowledge our study site coordinators for their outstanding work in assembling our national team in PROVE-AAA, including by not limited to Cory Gaudette, Francisco Grippa, Amy Voorhees, Kayla Moore (White River Junction/PROVE Coordinating Center), Catherine Dowse (Minneapolis, MN), Sarah Barbey (Gainesville, FL), Ann Galla and Lori Grove (Buffalo, NY), Karen Belanger (Ann Arbor, MI), Angela Karamoto (Phoenix, AZ), Veep Patel (Houston, TX), Susan Bigda (Seattle, WA), Sinan Jabori (Los Angeles, CA), Kevin Chun (Sacramento, CA), Julie Beckstrom and Maria Maloney (Salt Lake City, UT), Molly Schieber (Omaha, NE), Adam Zoble (Tampa, FL), Stephanie Anderson (West Haven, CT), and Michael Morrison (West Roxbury, MA). Funding: This study was funded by a multicenter clinical trials pilot grant from the Society for Vascular Surgery and MERIT Review Grant (015e85) from VA HSR&D.
Funding Information:
Funding: This study was funded by a multicenter clinical trials pilot grant from the Society for Vascular Surgery and MERIT Review Grant (015e85) from VA HSR&D.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2020/5
Y1 - 2020/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85078555631&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85078555631&partnerID=8YFLogxK
U2 - 10.1016/j.avsg.2019.02.034
DO - 10.1016/j.avsg.2019.02.034
M3 - Review article
C2 - 31075459
AN - SCOPUS:85078555631
SN - 0890-5096
VL - 65
SP - 247
EP - 253
JO - Annals of Vascular Surgery
JF - Annals of Vascular Surgery
ER -