Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: an International Trajectory (PORTRAIT Registry)

• Peripheral Artery Disease (PAD) - Specific health status [ Time Frame: One Year ] [ Designated as safety issue: No ]
  

• Cardiovascular events [ Time Frame: One Year ] [ Designated as safety issue: No ]
  

Peripheral arterial disease (PAD) is associated with a disproportionately poor prognosis, as compared with other atherosclerotic diseases. While poor risk factor treatment may partially explain PAD patients' poor clinical outcomes, cardiac events are only one manifestation of the disease. For PAD patients, their health status (symptoms, function, and quality of life) are critical outcomes of the disease. To date, however, there have been no systematic evaluations of disease-specific health status outcomes in PAD and how these vary by patient or treatment characteristics. These gaps in knowledge exist despite guidelines stating that the primary goals of PAD treatment should be symptom relief and quality of life improvement. Explicit hypotheses underlying PORTRAIT are that: PAD care is organized in a fragmented way (multiple specialists performing a myriad of treatments), is associated with a wide variation in initial treatment strategies. These variations will be reflected in different degrees to which providers adhere to guideline-recommended cardiovascular risk management strategies. It is also expected that racial, gender, and age disparities in treat-ment patterns and outcomes (patient-centered outcomes and prognosis) exist.

A total of 2 PAD specialty clinics (vascular surgery and interventional cardiology) will consecutively enroll 240 patients with new or recently exacerbated PAD symptoms. Treatment and disease-specific health status information at baseline and at 3, 6, and 12 months will be collected; and 1-year adjudicated follow-up on cardiovascular events will be organized to address the following specific aims:

Aim 1: Examine patient characteristics and variations in treatment strategies for PAD patients initially present-ing to a PAD clinic for care with new or an exacerbation of PAD symptoms Aim 2: Compare real world use of PAD care delivery strategies with current PAD performance measures Aim 3: Quantify the variability in patients' 1-year PAD-specific health status outcomes overall and as a func-tion of treatment and patient characteristics Aim 4: Evaluate 1-year rates of cardiovascular events; overall and by treatment and patient characteristics Virtually all of the aims are innovative, as prior research has been limited to procedural registries, smaller, generic health status studies, and heterogeneous cohorts, which partly explain why patients' health status have not yet become important standards in guiding PAD treatment. Accomplishing the proposed aims will be crucial to achieving our overarching goal of creating a multi-modal PAD management program; one that uses novel personalized and system-oriented approaches to increase the use of evidence-based guidelines and to optimize patients' outcomes. PORTRAIT is the first step towards achieving this goal and will enrich the evidence-base with real-world data so that concrete targets for future innovations in PAD care can be developed.