Elsevier

Annals of Vascular Surgery

Volume 65, May 2020, Pages 247-253
Annals of Vascular Surgery

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

https://doi.org/10.1016/j.avsg.2019.02.034Get rights and content

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.

Introduction

For patients with abdominal aortic aneurysm (AAA), endovascular AAA repair (EVAR) and open surgical repair (OSR) have been compared extensively in a variety of settings, including in large randomized trials.1, 2, 3, 4 In these studies, the less-invasive nature of EVAR repeatedly demonstrated several advantages over OSR in terms of short-term morbidity and mortality.5 However, EVAR benefits came with tradeoffs. Mandatory surveillance imaging is required for the patients' lifetime, and endoleaks requiring reintervention occur at a rate of nearly 20% at four years.6, 7, 8 These reinterventions often are endoleaks, which, in many cases, can be treated using endovascular means. Finally, late rupture is more common in patients treated with EVAR, and some randomized trials show a detriment in survival with patients over the long term for those treated with EVAR.6, 7, 8

These tradeoffs have made it difficult to find a clear “winner” between EVAR and OSR. Randomized trials gave surgeons and patients important information about the short- and long-term outcomes of each approach but have failed to identify a single AAA repair type that would be best for all patients. This is a setting wherein shared decision-making and patient decision aids may hold promise. It is our first hypothesis that patients, if cogent in their decision-making about the risks and benefits of both EVAR and OSR, would choose either EVAR or OSR for specific, measurable reasons. For example, patients may choose open repair if they prioritized durability or if they wished to avoid the need for long-term surveillance. Similarly, patients may choose EVAR if they prioritized a brief recovery. Our second hypothesis is that patients who are aware of these tradeoffs—the “informed consumer”—may be more likely to receive the type of repair that aligns with their preferences.

In this report, we describe a 20-site, cluster-randomized trial funded by VA Health Services Research and Delivery (VA HSR&D) designed to test this hypothesis. This study has two aims. First, we will use validated survey instruments to determine repair type preferences between EVAR and OSR and identify domains in our survey associated with each repair type. Second, we will determine the effect of a validated decision aid on the agreement between patient preference for AAA repair type and the repair type the patient ultimately receives.

Section snippets

Design of the Intervention

Poor alignment between treatment preferences can result in poor patient satisfaction and outcomes, especially in surgical decisions.9, 10 For example, patients treated with open repair may have a longer hospital stay, more time lost from employment, greater rates of depression, and more social isolation because of the longer recovery time.4, 11, 12, 13 Similarly, for patients treated with endovascular repair, the need for continued surveillance with radiation-based CT scans, worries about

Study Design

The PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) is a cluster-randomized trial, which compares the effect of two different mechanisms of patient education (a decision aid versus usual care) on the alignment between preferences and repair type for veterans facing repair of their AAA. We will compare these outcomes between our intervention groups, who receive the decision aid, and our control groups, who receive usual care, as shown in Figure 2. This

Study Sites and Institutional Review

Our study sites consist of twenty VA medical centers and their vascular surgery programs (Fig. 3). At each site, enrollment will consist of twelve Veterans referred to vascular clinic for an AAA at least 5.0 cm in diameter that can be treated by either endovascular or open repair, based on a preliminary review by a site principal investigator. Clinic schedules are reviewed by study coordinators before the veterans' appointment to determine those who will present with AAA within the size

Screening Processes and Enrollment Criteria

Before the veteran is seen by the surgeon, the study-related screening, consent, and enrollment will be performed by a site study coordinator. At ten intervention sites, the site study coordinator will administer a presurvey, a decision aid, and survey. At ten control sites, the site study coordinator will administer the survey alone. In both groups, the veteran will proceed with a vascular surgery clinic visit. We will follow up all patients for two years. When veterans undergo repair, our

Cluster Randomized Study Design

Notable in our study design is the use of a cluster-randomized intervention rather than a simple randomization scheme. A cluster-randomized design means that the randomized aspects of the study—whether or not the patient receives the decision aid—occurs at the level of the study site, or cluster, rather than at the patient level. In other words, each site, rather than each patient, is randomized to one treatment arm or the other.

Why choose this approach? We did so because this approach avoids

Study Intervention and Power

This is a clinic-based intervention and will occur in vascular surgeon clinics at the VA hospitals in our study. After either receiving the decision aid or usual advice, the veteran then proceeds through their clinic appointment and then has their remaining interaction with the study team. For some patients, repair will ensue soon thereafter, whereas others will undergo repair. Patients receive a follow-up survey instrument aimed at measuring their satisfaction with their decision.

We

Importance and Health Relevance of Study

The importance and significance of our proposal lies in our structured approach toward studying preference-based AAA repair. Although survival at two years after endovascular and open repair is similar, tradeoffs between the short-term benefits and long-term risks of endovascular and open repair can make it difficult for patients to make the best choices. Our study will directly address these challenges.

New Methodologies to Be Used in Our Study

First, our study design involves the use of shared decision-making strategies in determining treatment preferences for patients with AAA. Although shared decision-making has been used extensively in helping patients make choices about long-term care options and other difficult health-related decisions,26 it has been largely unexplored in deciding on vascular surgery treatment. This approach has been used primarily in orthopedic surgery and cancer surgery decisions9, 10, 27, 28, 29—but rarely

Summary

With the introduction of EVAR more than 20 years ago, patients with AAA were presented with a new option for a treatment wherein they left the hospital in days rather than weeks and recovered back to their usual activities in weeks rather than months. However, with these new opportunities came new challenges, such as the concept of an intraluminally repaired aortic aneurysm as a “chronic disease,” which requires surveillance and potentially have complications from endoleaks, limb thrombosis, or

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      In contrast, the primary goal of patient-centered care is to improve individual outcomes and quality of life through enhanced communication and patient engagement.15 Efforts to optimize this communication were studied in The Preferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Trial,16 which examined the alignment of patient preferences for AAA repair with the actual type of treatment they received. The early findings from this trial revealed the general lack of information patients received about AAA disease, indications for repair, or methods of repair even as they were being referred for surgery.17

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      The difficulty in clearly identifying an optimal path for each patient’s AAA repair requires a shared decision-making process in order to achieve high alignment of patient goals, medical outcomes, and general patient satisfaction.8,9 The PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) trial aimed to determine the efficacy of a validated decision aid to enable better matching between patient preference and their ultimate repair.10 Importantly, this trial used validated surveys and open-ended questions to better identify factors and information sources that influenced each patient’s preference between OSR and EVAR.

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      Enrolled Veterans had a AAA measuring at least 5.0 cm in anterior-posterior diameter, and were both anatomical and physiological candidates for both OSR and EVAR. Detailed description of study design and aims was described by Columbo et al.10 The PROVE-AAA trial was granted Central Institutional Review Board approval by the Veteran's Health Administration and registered at ClinicalTrials.gov (www.clinicaltrials.govNCT03115346). The use of patient responses in this qualitative analysis fell within the scope of informed consent obtained during patient enrollment in the PROVE-AAA trial.

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    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.

    Clinical Trial Registration: clinicaltrials.gov NCT02220686.

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