Prevention of Ischemic Events in Patients With Peripheral Arterial Disease

Completed

Conditions: Peripheral Arterial Disease

Interventions: Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice

Registration Number: NCT00761969

Lead Sponsor: KRKA

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1455

Inclusion Criteria

Patients with PAD: ankle-brachial pressure index <= 0.90
Controls: palpable pedal pulses, ankle-brachial pressure index 0.91-1.30

Exclusion Criteria

Age < 40 or > 80 years at inclusion
Malignancy with a life expectancy < 5 years
Atherothrombotic event within a month before inclusion (acute coronary syndrome, stroke or documented transient ischemic attack, critical limb ischemia)
pregnancy

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice	Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
PAB	Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice	Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.

Primary Outcome Measures

Name	Time	Method
Incidence of Major Cardiovascular Events	5 years:	Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.

Secondary Outcome Measures