Effects of lovastatin in prevention of restenosis after percutaneous transluminal angioplasty in lower limbs

Abstract

Percutaneous transluminal angioplasty (PTA) is frequently complicated by restenosis of the dilated arterial segment within a few months after the angioplasty. Cholesterol-lowering drugs have been shown to reduce the rate of restenosis after PTA, but the role of lipid fractions in susceptibility to restenosis after balloon angioplasty is not clear. The present prospective and randomized study was executed to find out the effects of lovastatin on restenosis after PTA in the arteries below the inguinal ligament. PTA was performed in 37 patients (age 68 ± 12 years) because of severe claudication or critical ischemia of lower limbs. Regardless of their preoperative blood cholesterol level, all patients were given diet information and thereafter randomized into two groups, one receiving 250 mg asetosalisylic acid (ASA group, n = 19) and one receiving 250 mg ASA and 20 mg of lovastatin (lovastatin group, n = 18) daily. Clinical status was followed up for 1, 4, and 12 months after PTA. Control angiography was performed in every patient 12 months after PTA. However, if the clinical status suggested critical ischemia, angiography and necessary procedures were performed before 12 months. Two radiologists evaluated all angiographs independently and without knowledge of the medication patients were receiving. In the ASA group, forty-two percent (8/19) of the patients had total restenosis of the dilated segment 4.5 ± 1.2 months after the first PTA, whereas only 22.2% (4/18) of the patients in the lovastatin group had total restenosis 2.8 ± 1.5 months after the initial treatment. There were 2/18 amputations (11.1%) in the lovastatin group and 4/19 (21.1%) in the ASA group during the first year of surveillance. Total plasma cholesterol decreased from 6.0 ± 1.1 mmol/L to 5.0 ± 1.4 mmol/L, and cholesterol index (total cholesterol/ HDL-cholesterol) decreased from 5.4 ± 2.3 to 4.9 ± 2.5 in the lovastatin group during the follow-up period. In the ASA group, both plasma total cholesterol and cholesterol index stayed virtually at the same level. The number of restenosis and amputations in the ASA group was twice as high as in the lovastatin group 1 year after PTA. These preliminary results suggest that lovastatin has a beneficial effect on restenosis after balloon angioplasty.