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Background: Peripheral arterial disease (PAD) is highly prevalent among individuals of higher age or those with one or more cardiovascular risk factors. Screening for PAD is recommended, since it is often linked to atherothrombotic manifestations in the coronary or carotid circulation and associated with a substantial increase in all-cause and cardiovascular mortality. We aimed to assess patients with newly diagnosed, suspected and confirmed PAD in the primary care setting with regards to clinical characteristics, diagnostic and therapeutic management (including referral to specialists), and medium-term outcomes. Methods: This was a multicentre, prospective, observational cohort study with a cross-sectional and a longitudinal part. A total of 2,781 general practitioners across Germany were cluster randomised to document five consecutive patients each in one of the strata: (1) patients with intermittent claudication (IC) or other typical PAD-related complaints (group A) or (2) patients >55 years of age with one or more risk factors (group B) for PAD (current smoking, diabetes, previous myocardial infection and/or previous stroke). Patients with confirmed PAD will be followed up for diagnostic procedures, therapy and vascular events over 18 months. Results: In group A, a total of 2,131 patients with suspected PAD (80.1% confirmed, 75.9% with referral to specialists) and in group B 9,921 patients were included (44.6% confirmed, 54.6% referral). The ankle-brachial index was calculated in 41.3% and 33.5% only. Mean age was 66.6 years (group A) and 68.4 years (group B), respectively. Vascular risk factors were prevalent in both groups, in particular smoking (group A 44.6%, group B 44.4%), hypertension (73.2 and 78.1%), hypercholesterolaemia (64.6 and 70.6%) and diabetes mellitus (41.7 and 60.6%). Concomitant atherothrombotic morbidities were frequent in both groups. In patients with the respective diseases, antihypertensive, antidiabetic, lipid-lowering and antithrombotic therapies were prescribed in group A in 96.6, 96.0, 91.1 and 89.7% and in group B in 98.3, 97.4, 94.1 and 91.2%. Conclusion: The cross-sectional part of the study indicates a substantial burden of disease in PAD patients in primary care. Treatment rates appear to have improved compared to earlier surveys. In the follow-up period, outcomes of these patients and their association with disease stages, guideline-oriented treatment or patient compliance and disease-coping strategies, among other factors, will be determined.

Aim: Peripheral arterial disease (PAD), a marker of elevated vascular risk, is highly prevalent in general practice. We aimed to investigate patient characteristics and outcomes of PAD patients treated according to the guidelines versus those who were not. Methods: The Patient Care Evaluation-Peripheral Arterial Disease Study (PACE-PAD) was a multicenter, cluster randomized, prospective, longitudinal cohort study of patients with PAD in primary care, who were followed up for death or vascular events over 18 months. Guideline orientation was assumed if patients received anticoagulant/antiplatelet therapy, exercise training, and (if applicable) advice for smoking cessation and therapy of diabetes mellitus, hypertension, or hypercholesterolemia, respectively. Results: Of the 5,099 PAD patients (mean age 68.0 ± 9.0 years, 68.5% male subjects) who were followed up, 22.5, 34.6, 30.1, 7.8, and 3.5% (1.5% not specified) were in Fontaine stages I, IIa, IIb, III, and IV. Comprehensive guideline orientation was reported in 28.4% only; however, patients in lower Fontaine stages received guideline-oriented therapy more often (I: 30.3%, IIa: 31.6%, IIb: 29.1%, III: 9.8%, IV: 18.0%). During 18 months, 457 patients died (224 due to cerebrovascular or coronary deaths), 319 had unstable angina pectoris, 116 myocardial infarction, and 140 an ischemic stroke event. In total, 24% of patients had experienced any vascular event (19.1% a first event). Event rates did not differ between patients treated according to guidelines and those who were not. Conclusion: The present PAD cohort was a high-risk sample with an unexpectedly high rate of deaths and vascular events. While physicians appear to focus on the treatment of individual risk factors, rates of comprehensive PAD management in line with guideline recommendations are still suboptimal. Factors contributing to the lacking difference between outcomes in the guideline-oriented and non-guideline-oriented groups may comprise low treatment intensity or other reasons for unsatisfactory effect of treatment, misclassification of events, and patient's noncompliance with therapy.