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.
