Peripheral Arterial Disease Clinical Trial
Official title:
Health-economic Evaluation of the Care Pathway in General Medicine for High Cardiovascular Risk Patients Based on the Detection of Asymptomatic Lower Limb Peripherial Arterial Disease (AOMI) by the Blood Pressure Index (BPI).
Cardiovascular pathologies (CV), the second leading cause of death just behind tumors, are
particularly frequent in France and strongly mobilize the resources of the healthcare system
(ambulatory and health facility). The French High Authority for Health (HAS) has defined
major cardio-vascular risk factors (CVRF): smoking, high blood pressure (hypertension),
elevated total cholesterol (TC) or LDL, decreased HDL cholesterol, type II diabetes and age,
and predisposing CVRF or discussed: obesity, sedentary lifestyle, menopause, elevation of
triglycerides and genetic factors.
Lower-linb peripherial arterial disease (AOMI), even if asymptomatic, involves systemic
atherial disease, responsible for mortality irrespective of the presence of CVRF. The
prevalence of asymptomatic AOMI is 10 to 20% beyond 55 years old, and the associated
mortality is 18 to 30% at 5 years.
Individual screening is achievable by well-conducted clinical evaluation and systematic
measurement of the simple, non-invasive Blood Pressure Index (BPI) in all subjects at risk. A
BPI<0.9 indicates an event risk close to that of the symptomatic patient. However, if this
strategy is recommended by the HAS, it is not carried out systematically in current practice.
Therapeutic means available for the management of an asymptomatic AOMI are the identification
and support for controllable CVRF such as smoking and nutrition (diet and physical activity)
in the context of secondary prevention of atherosclerosis. Thus, the generalization of a
systematique screening strategy of AOMI, allowing faster handling of CVRF by advices and
Motivational Interviewing (MI), could have a significant impact, both clinically and
economically.
Patients could also benefit from this support in terms of quality of life both on the
physiological dimension (effect of weight loss, correction of disorders of cardiac function,
etc.), that on the psychic dimension (well-being of patients, management of disorders
anxious). However, few studies have evaluated the benefit of such a strategy in terms of
quality-adjusted life years (QALYs),none did it on a cost recovery basis. No such studies
have been conducted in France.
The feasibility of this project is based on the success of a pilot study conducted in
Centre-Val de Loire region (France) in 2013. It showed that the implementation of a strategy
of systematic screening of the asymptomatic AOMI based on the measurement of the BPI in high
cardiovascular risk patients is feasible in current practice by general practitioners, and
could be more efficient than interventions performed in current practice.
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