Candesartan treatment for peripheral occlusive arterial disease after stent angioplasty : a randomised, placebo-controlled trial.

OBJECTIVES: In this prospective, double-blind, placebo-controlled study we observed the influence of treatment with candesartan 8mg on restenosis rates after stent implantation into the femoral artery 6 months after percutaneous transluminal angioplasty (PTA). We hypothesised that angiotensin II type 1 (AT1)-receptor blockade with candesartan would reduce restenosis rates by reducing angiotensin II-mediated intima hyperproliferation within the stented vessel segment in patients with peripheral occlusive disease. PATIENTS AND METHODS: Eighty-seven patients with peripheral occlusive arterial disease stage IIb who had been successfully treated with PTA and stent implantation were randomised to receive orally either candesartan 8mg (n = 44) or placebo (n = 43). Follow-up included evaluation of the degree of stenosis and thickness of the intima-media complex (primary endpoint). In addition, thickness of the interventricular septum, crurobrachial pressure ratios, and pain-free walking distance were determined (secondary endpoints).
RESULTS: The degree of stenosis after 6 months was not significantly different between the groups studied (35.9 +/- 39.6% for candesartan vs 36.0 +/- 38.4% for placebo). Relevant restenosis including stent occlusions was found in nine patients (20.5%) in the candesartan group and in ten patients (23.3%) in the placebo group. The thickness of the intima-media complex 6 months after stent implantation was 1.60 +/- 0.32mm in the candesartan group and 1.64 +/- 0.32mm in the placebo group (not significant). There were no differences in secondary endpoints between the treatment groups. Controls after 3 months (20.9 +/- 33.6% for candesartan vs 27.6 +/- 38.3% for placebo; p = 0.39) and 9 months (44.1 +/- 40.8% for candesartan vs 47.7 +/- 37.2% for placebo; p = 0.67) of therapy revealed a lower degree of stenosis in patients treated with candesartan.
CONCLUSIONS: Although not significant, candesartan treatment tended to improve the prognostic benefits after stent implantation, suggesting that an antiproliferative effect after stenting may need higher doses than an antihypertensive effect of the drug. This hypothesis requires confirmation in further prospective studies with higher daily doses of candesartan, which are already in progress.

RCT Entities:   Population Interventions Outcomes