Peripheral Arterial Disease Clinical Trial
Official title:
Prevention of Ischemic Events in Patients With Peripheral Arterial Disease by the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice
The PID-PAB study aims to test the efficacy of the European Guidelines on Cardiovascular Disease Prevention in patients with peripheral arterial disease. Survival, the rate of major atherothrombotic events (myocardial infarction, stroke, critical limb ischemia) and the incidence of revascularization procedures will be compared between a group of patients with stable peripheral arterial disease (PAD) and age- and sex-matched control subjects without PAD. Both groups will be receiving up-to-date medical care according to their cardiovascular risk based on the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. Yearly follow-up is planned for 5 years. The PID PAB study aims to test (a) whether stable PAD is still an adverse prognostic indicator in spite of contemporary preventive measures, and (b) to what extent do contemporary preventive measures improve the prognosis of patients with PAD in comparison to historic controls, representing the natural history of the disease.
The observational study Prevention of Ischemic Events in Patients with Peripheral Arterial
Disease by the European Guidelines on Cardiovascular Disease Prevention (Slovenian acronym
of the study: PID-PAB)aims to test the efficacy of the European Guidelines on Cardiovascular
Disease Prevention in patients with peripheral arterial disease, who have an even higher
mortality rate than patients with isolated coronary artery disease or cerebrovascular
disease when left to the natural course of the disease. The PID-PAB study will compare the
rates of survival, major atherothrombotic events (myocardial infarction, stroke, critical
limb ischemia) and revascularization procedures between a group of patients with stable
peripheral arterial disease (PAD) and a control group of age- and sex-matched subjects
without PAD. Both groups will be receiving up-to-date medical care (including life-style
advice and prescription of cardioprotective medication) according their cardiovascular risk
based on the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice.
PAB is defined by a reduced ankle-brachial pressure index of =< 0.90, while absence of PAD
is defined by palpable pedal pulses and a normal ankle-brachial index (0.91-1.30). Exclusion
criteria are: age < 40 or > 80 years at inclusion, active cancer or other disease with a
life expectancy of les than 5 years, any major atherothrombotic event in 30 days prior to
enrollment, and pregnancy. All subjects will be followed annually for 5 years by
comprehensive medical examinations. The settings of the study are primary care facilities in
Slovenia, European Union. The target size of each group is 1000 subjects, i.e., 5000 patient
years. The number of participating physicians-researchers is estimated at 100, with a goal
for each physician to recruit 10 patients with PAD and 10 age- and sex-matched controls. The
study is coordinated by a steering committee consisting of researchers from the Department
of Vascular Diseases at the University of Ljubljana Medical Centre, Institute of Biomedical
Informatics at the University of Ljubljana School of Medicine, Department of Family Medicine
at the University of Ljubljana School of Medicine and the pharmaceutical company Krka,
Slovenia, who is also the sponsor of the study. The protocol of the study has been approved
by the Committee of Medical Ethics of the Republic of Slovenia.
The PID PAB study aims to answer the questions:
1. Is stable PAD is still an adverse prognostic indicator in spite of contemporary
preventive measures?
2. To what extent do contemporary preventive measures improve the prognosis of patients
with PAD in comparison to historic controls (described in earlier reports on the
natural history of PAD ? We expect to still find a significant difference in the rate
of cardiovascular events between patients with PAD and their peers without PAD, but we
hypothesize that contemporary preventive measures will strongly attenuate the adverse
prognosis of PAD regarding survival and major atherothrombotic events in comparison to
the natural history of the disease.
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