Prevention of Ischemic Events in Patients With Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice
Intervention type(s): Other
Intervention description(s): Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with stable, objectively confirmed PAD, recruited from primary care settings in
        Slovenia, Europe.

        Control subjects of comparable age- and sex-distribution, without PAD, recruited from
        primary care settings in Slovenia, Europe.
      
Biospecimen description: 
      blood (16 ml) for analysis of inflammatory markers (from serum) and genotyping, to be
      correlated with clinical outcomes.

      Anonymity of patients is proveded by coding the samples and the patients clinical records.
    
Keywords: peripheral arterial disease; secondary prevention; cardiovascular /atherothrombotic events; European guidelines; Cardiovascular disease prevention