Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication

Reduction de la Morbi-mortalité Cardiovasculaire Chez l'artériopathe Claudicant Par le Sildenafil

Sildenafil has shown potential effects both on vasodilator mechanisms and as an inhibitor of the NO/GMPc Pain activation. The investigators aim at estimating the benefit of sildenafil in term of morbi-mortality in patients with arterial claudication on a multicenter prospective double blind study.

Eligible patients will ask to participate after oral and written information. Evaluation of walking capacity (self reported and treadmill measured), co-morbid condition and quality of life (WELCH, SF-36, Edinburg) will be performed at inclusion, after the first dose and at 3 months of oral treatment through sildenafil 100mg/day or placebo from inclusion to 3 months.

Indication for revascularisation will be evaluated at 3 months according to symptoms and walking capacity according to the Rutherford classification.

Primary endpoint is the proportion of patients showing either a fatal events (cardio-vascular or noncardiovascular) or hospitalisation for non fatal cardiovascular events at 6 and 9 months follow up from inclusion.

Inclusion Criteria:

• ABI<0.90
• Vascular type claudication
• stable walking impairment for at least 3 months
• Optimal cardiovasc treatment (Anti-platelet, HMGCoA-Inh, ACE-Inh or AT2 inh)
• Age > 30 years

Exclusion Criteria:

• Refuse to participate
• Administrative protection
• Severe renal (clearance < 30 ml/min) or hepatic (Child-Pugh C) failure