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Abstract
Objective:
Peripheral arterial disease (PAD), an established marker of premature death and cardiovascular risk in general, is highly prevalent. We analysed factors associated with poor outcomes in an observational cohort, with particular focus on the effect of guideline orientation in the management of these patients.
Methods:
PACE-PAD is a multicentre, prospective, observational study of PAD patients in primary care. PAD guideline orientation was stated, if patients received the following: exercise training, (if applicable) advice for smoking cessation and diet, therapy for diabetes mellitus, hypertension, hypercholesterolaemia, or antiplatelets/anticoagulants. Multivariate regression models were applied to assess factors associated with all cause death, cardiovascular/cerebrovascular death, or cardiovascular/cerebrovascular/peripheral vascular non-fatal events.
Results:
After an 18-month follow-up, of the 5099 PAD patients analysed (mean age 68.0 ± 9.0 years, 68.5% males), only 28.4% of patients met all applicable quality indicators for guideline-oriented treatment. However, most patients were to a large extent managed in line with guidelines. While exercise training was reported in 41.8%, rates were very high for smoking cessation (90.7%), therapy for hypertension (92.5%), diabetes mellitus (82.0%), hypercholesterolemia (83.3%) and antiplatelet therapy (86.7%). Regarding events, there were inhomogeneous results with a statistically significant higher rate of cardiovascular/cerebrovascular deaths and all-cause deaths, but a lower rate of non-fatal vascular events in patients treated according to guidelines compared to those who were not. Limitations of this study include the open, non-controlled design, possible patient selection bias and misclassification of events.
Conclusion:
Even if the guideline orientation for the various indicators was remarkably stable across the three follow-up visits, the rate of patients comprehensively treated according to the guidelines was relatively low, which calls for optimisation. There was a lack of differentiation between the guideline-oriented and non-guideline-oriented therapy in terms of outcomes, which may be due to patient-related or other factors, and warrants further research.
Transparency
Declaration of funding
The study was supported with an unrestricted grant from Sanofi-Aventis, Berlin, Germany.
Conflict of financial/other interests
The authors have disclosed that they have no relevant financial or other competing interests to disclose with regards to this study.
A.N., J.W., F.H. and R.J. participated in study conception and design, acquisition of data, analysis and interpretation of data, funding acquisition, and drafting and critical revision of the paper for important intellectual content. H.P., E.D., O.O., D.P. and C.D. advised on the study design. U.S. did the sample size calculations and G.L. the statistical calculations. All authors accept responsibility for the scientific content of the paper.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgements
The PACE-PAD study group was supported by an advisory board founded in 2003 with the following members: Hans Jürgen Ahrens, Curt Diehm, Leonhard Hansen (until 2004), and Klaus-Dieter Kossow. The support of the participating GPs is highly appreciated.
The authors thank Anna Neumann for her strong commitment in the project office.