(Circulation. 1995;92:1758-1764.)
© 1995 American Heart Association, Inc.
Articles |
Kuopio Atherosclerosis Prevention Study (KAPS)
A Population-Based Primary Preventive Trial of the Effect of LDL Lowering on Atherosclerotic Progression in Carotid and Femoral Arteries
From the Research Institute of Public Health, University of Kuopio (Finland) (R.S., K.N., E.P. J.R., J.T.S.), and the Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, NJ (R.B., J.-S.P.).
Correspondence to Prof Jukka T. Salonen, Research Institute of Public Health, University of Kuopio, PO Box 1627, 70211 Kuopio, Finland.
Background The atherosclerotic progression–reducing effect of LDL cholesterol (LDL-C) lowering has been established in subjects with severe atherosclerotic disease but not in persons with elevated LDL cholesterols without severe atherosclerosis. KAPS (Kuopio Atherosclerosis Prevention Study) is the first population-based trial in the primary prevention of carotid and femoral atherosclerosis.
Methods and Results The eligibility requirements were serum LDL-C
4.0 mmol/L and total cholesterol <7.5 mmol/L. Out of a
geographically defined population, 447 men aged 44 to 65 years (mean,
57) were randomized to pravastatin (40 mg/d) or placebo for
3 years. Less than 10% of the subjects had prior myocardial
infarction. Thirty-nine men discontinued study medication; however,
efficacy data were available for 424 men. The primary outcome was the
rate of carotid atherosclerotic progression, measured as the linear
slope over annual ultrasound examinations in the average of the maximum
carotid intima-media thickness (IMT) of the far wall of up to four
arterial segments (the right and left distal common carotid
artery and the right and left carotid bulb). For the carotid arteries,
at the overall mean baseline IMT of 1.66 mm, the rate of progression of
carotid atherosclerosis was 45% (95% CI, 16 to 69%)
less in the pravastatin (0.017 mm/y) than the placebo
(0.031 mm/y) group (P=.005). In the common carotid artery
there was a treatment effect of 66% (95% CI, 30 to 95%;
pravastatin 0.010 mm/y; placebo 0.029 mm/y;
P<.002) at the overall mean baseline IMT of 1.35 mm. A
treatment effect of 30% (95% CI, -1% to 54%) was found for the
carotid bulb (pravastatin, 0.028; placebo, 0.040;
P=.056) at the overall mean baseline IMT of 2.0 mm. The
treatment effect was larger in subjects with higher baseline IMT
values, in smokers and in those with low plasma vitamin E levels. There
was no significant treatment effect on atherosclerotic progression in
the femoral arteries.
Conclusions These data establish the antiatherogenic effect of LDL-C lowering by pravastatin in hypercholesterolemic men in a primary prevention setting and suggest a greater effect in smokers than in nonsmokers.
Key Words: smoking • lipoproteins • clinical trials • atherosclerosis
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