Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study

Abstract

BackgroundLower extremity peripheral arterial disease (PAD) is a marker of widespread atherosclerosis. Individuals with PAD, most of whom do not show typical PAD symptoms ('asymptomatic' patients), are at increased risk of cardiovascular ischaemic events. American College of Cardiology/American Heart Association guidelines recommend that individuals with asymptomatic lower extremity PAD should be identified by measurement of ankle-brachial index (ABI). However, despite its associated risk, PAD remains under-recognised by clinicians and the general population and office-based ABI detection is still poorly-known and under-used in clinical practice. The Prevalence of peripheral Arterial disease in patients with a non-high cardiovascular disease risk, with No overt vascular Diseases nOR diAbetes mellitus (PANDORA) study has a primary aim of assessing the prevalence of lower extremity PAD through ABI measurement, in patients at non-high cardiovascular risk, with no overt cardiovascular diseases (including symptomatic PAD), or diabetes mellitus. Secondary objectives include documenting the prevalence and treatment of cardiovascular risk factors and the characteristics of both patients and physicians as possible determinants for PAD under-diagnosis.Methods/DesignPANDORA is a non-interventional, cross-sectional, pan-European study. It includes approximately 1,000 primary care participating sites, across six European countries (Belgium, France, Greece, Italy, The Netherlands, Switzerland). Investigator and patient questionnaires will be used to collect both right and left ABI values at rest, presence of cardiovascular disease risk factors, current pharmacological treatment, and determinants for PAD under-diagnosis.DiscussionThe PANDORA study will provide important data to estimate the prevalence of asymptomatic PAD in a population otherwise classified at low or intermediate risk on the basis of current risk scores in a primary care setting.Trial registration numberClinical Trials.gov Identifier: NCT00689377.

The PANDORA study: peripheral arterial disease in patients with non-high cardiovascular risk

“…PANDORA was a non-interventional, cross-sectional, panEuropean study (NCT00689377) [15]. A total of 591 centres across six countries (Italy, Belgium, France, The Netherlands, Greece and Switzerland) were involved in the study, which was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki, consistent with International Conference on Harmonisation/Good Clinical Practice and applicable regulatory requirements.…”

Prevention of Collagen-Induced Platelet Binding and Activation by Thermosensitive Nanoparticles

“…Despite increased awareness and advances in treatment and prevention, 25% of adults over the age of 55 develop PAD, and this incidence rate increases with age and other cardiovascular risk factors such as smoking and hypertension (1)(2)(3)(4)(5)(6). PAD is also associated with increased cardiovascular morbidity, such that the development of an effective long-term treatment is important for the large population affected by this disease (7,8).…”

Characteristics and Long-Term Follow-Up of Participants with Peripheral Arterial Disease During ALLHAT

“…17,33 PAD is a marker for high cardiovascular risk, including risk of mortality. 34,35 In these analyses PAD is associated with high post-event mortality: 70 % over 10 years of follow-up. Reduction of major modifiable risk factors, including hypertension, is critical, but the optimal antihypertensive therapy, when considering multiple cardiovascular disease outcomes, remains undetermined.…”