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European Heart Journal 1999 20(19):1393-1406; doi:10.1053/euhj.1999.1483
Copyright © 1999 by the European Society of Cardiology.
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Effects of lovastatin on progression of non-dilated and dilated coronary segments and on restenosis in patients after PTCA. The Cholesterol Lowering Atherosclerosis PTCA Trial (CLAPT)

A. Kleemanna,b,f2, S. Eckertc, A. von Eckardsteina,d, W. Leppere, U. Schernikauf, U. Gleichmannc, P. Hanrathe, E. Fleckf, A. Neissg, S. Kerbera,b, G. Assmanna,d and G. Breithardt and the CLAPT Study Groupa,b CLAPT Study-Groupf1

a Institute for Arteriosclerosis Research, Münster
b Departments of Cardiology, University of Münster, Münster
c University of Bochum and Heart Center of North-Rhine Westphalia, Bad Oeynhausen
e University of Aachen, Aachen
f German Heart Institute Berlin, Berlin
d Institute of Clinical Chemistry and Laboratory Medicine, Münster
g Institute of Medical Statistics and Epidemiology, Technical University Munich, Munich, Germany

Received December 8, 1998; accepted December 16, 1998

Abstract

Objectives The Cholesterol Lowering Atherosclerosis PTCA Trial (CLAPT) is a prospective, randomized trial with blinded angiographic end-points to assess the effect of 2-year's treatment with lovastatin initiated 4 weeks prior to PTCA, compared to usual care on non-dilated coronary segments and on dilated coronary lesions in male patients with total cholesterol between 200 and 300mg.dl–1who underwent elective PTCA.

Methods and Results Two hundred and twenty six patients were randomized 4 weeks prior to PTCA to special care (diet plus lovastatin n=112) or usual care (diet; n=114). One hundred and ninety-nine patients underwent PTCA at baseline and were finally included in the study. Quantitative coronary angiographic assessment was performed on blinded cinefilms at baseline (PTCA) and repeated after 4 and 24 months in 91% and 81% of the patients. The primary end-point was a change in the mean segment diameter of non-dilated segments. The mean lovastatin dose was 33mg.day–1. Total- and LDL-cholesterol decreased by 21% and 29% in the special care group and by 7% and 11% in the usual care patients.

After 2 years, the mean segment diameter of non-dilated segments decreased by 0·03mm in the usual care group and 0·004mm in the special care group (P=0·27). The decrease in the mean segment diameter of dilated lesions was 0·17mm (usual care) and 0·06mm (special care) (P=0·04) after 4 months; 0·16mm (usual care) and 0·002mm (special care) after 24 months, respectively (P=0·05). In both groups, the mean segment diameter of dilated lesions increased between 4 and 24 months after PTCA compared to a decrease in mean segment diameter of non-dilated segments (P<0·05). Restenosis (>50% diameter stenosis at follow-up) occurred in 28·4% of usual care and 22·2% of special care patients (P=0·17).

Conclusions Lovastatin reduced the progression of dilated lesions in men with elective PTCA. Independent of treatment allocation, the dilated lesions regressed and the non-dilated segments progressed during the study follow-up. Four weeks of pre-treatment with lovastatin did not influence the rate of restenosis. Lovastatin had no statistically significant effect on non-dilated segments.

Key Words: Atherosclerosis, restenosis, lovastatin, clinical trial

f2 Correspondence: Dr Andreas Kleemann, Department of Cardiology, University of Münster, 48129 Münster, Germany.

f1 See Appendix for complete listing of CLAPT study personnel. The CLAPT study was sponsored by Merck, Sharp & Dohme, Germany.

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