Screening Asymptomatic Systemic Atherosclerosis in Patients with PAD: The Ev’Art Study

1. Screening AsymptomaticSystemicAtherosclerosisin Patients with PAD: The Ev’ArtStudy Patrick Carpentier for the Ev’Art Investigators Société Française de Médecine Vasculaire

2. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study The Fate of the PAD Patient

3. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study French “Haute Autorité de Santé”: Tests to be performed in PAD patient(June 2008)

4. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Screening Justification • .Benefit when a lesion is discovered • Complication rate of the screened lesion • Specific treatment for the lesion • Benefit / Risk balance of the treatment procedure (including pretreatment investigations) in the asymptomatic patient. • Feasability - Efficacy • Sensitivity and Specificity of the screening test: • False positives will be exposed to the treatment related risks for no benefit. • False negatives will not have the chance of the treatment related benefit. • Prevalence of the lesions in the screened population

5. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Prevalence of CarotidStenosis in PAD

6. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Prevalence of AorticAneurysm in PAD

7. EValuation of SystemicAtherothrombosis in patients withARTerialdisease of the lowerlimbsObservationalCohortStudy Société Française de Médecine Vasculaire & Institut de l’Athérothrombose

8. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Objectives • Prevalence and risk factors, at the time of the diagnosis of PAD, for • asymptomatic carotid stenosis • abdominal aortic aneurysm • Clinical survey: • Which cardiac and renal explorations are performed in those PAD patients? • What kind of decisions are made about the management of the detected carotid and aortic lesions? • Incidence and predictors of cardiovasc. events at 3 years in these patients

9. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Objectives • Prevalence and risk factors, at the time of the diagnosis of PAD, for • asymptomatic carotid stenosis • abdominal aortic aneurysm • Clinical survey: • Which cardiac and renal explorations are performed in those PAD patients? • What kind of decisions are made about the management of the detected carotid and aortic lesions? • Incidence and predictors of cardiovasc. events at 3 years in these patients

10. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Inclusion Criteria • Patient with newly diagnosed PAD <1 year • Symptomatic or asymptomatic: • ABI < .90 at rest • claudicants with ABI<.85 after treadmill test • symptomatic patients (Edimburgh questionnaire or trophic changes) with ABI > 1.30 • Without any history of previous coronory nor cerebrovascular event • With no previous investigation of the aorta and cervical arteries.

11. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Cross-SectionalStudy Systematic Standardized Evaluation • Caracterisation of the PAD: risk factors, main sites and severity of the atherosclerotic lesions (US Duplex) • Clinical evaluation of undetected previous CV events (TIA…) • Standardized US Duplex examination of the abdominal aorta and carotid arteries • Carotid stenosis : Sys Peak Velocity > 160cm/s • AAA : ant-post. diameter > 30mm

12. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Methods (continued) • Observational multicentre study • 70 French vascular physicians (hospital / private practice) • Electronic CRF (trough website) • Team of research assistants (INSERM Clinical Investigation Center - Grenoble) • Calculated number of investigated subjects • on the basis of the precision of prevalence estimates • if prevalence # 7%, a CI[0.95] of 1.5% requires a sample of 1000 subjects

13. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study PreliminaryResults: 455 Subjects • F/M: 135/320 (F=30%) • Age (median, range): 64 years (31-97) • ClinicalstatusABI (rest)<.7 48% • Permanent isch. 16% [.7;.9[ 42% • Claudicants 66% [.9;1.3] 7% • Subclinical PAD 18% >1.3 3% • RiskFactors: Tobacco 78% • Hypertension 59% • Hyperchol. 43% • Diabetes 28%

14. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Diameter of the Aorta 17 detectedaneurysms (30-44mm) : 4.2%

15. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study DetectedAneurysms • Clinicalstatus • Permanent ischemia (n=60) 3.3% • Claudicants (n=256) 4.1% • Subclinical PAD (n=69) 5.8% • ABI (rest)<.7 (n=186) 3.8% • [.7;.9[ (n=151) 4.6% • [.9;1.3] (n=25) 12% • >1.3 (n=13) 0%

16. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study CarotidStenosis • Wholesample(SPV>160cm/s) 22/387=5.7% • SPV>250cm/s 7/387=1.8% • Clinicalstatus • Permanent ischemia (n=60) 10.8% • Claudicants (n=248) 4.4% • Subclinical PAD (n=65) 6.2% • ABI (rest)<.7 (n=173) 6.7% • [.7;.9[ (n=143) 2.8% • [.9;1.3] (n=23) 0% • >1.3 (n=14) 14%

17. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Preliminary Conclusions • Prevalence of abdominal aortic aneurysms and carotid stenosis is lower than in the literature. • This is probably related to the inclusion of newly diagnosed patients. • Determination of well defined subgroups with high prevalence will be an important contribution of this study.

18. Screening PAD Patients for Systemic Atherosclerosis: Ev’ Art Study Investigators of Ev’ArtStudy