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)

• Published in: European heart journal 1999-10, Vol.20 (19), p.1393-1406
• Main Authors: Kleemann, A., Eckert, S., von Eckardstein, A., Lepper, W., Schernikau, U., Gleichmann, U., Hanrath, P., Fleck, E., Neiss, A., Kerber, S., Assmann, G., Breithardt and the CLAPT Study Group, G.
• Format: Article
• Language: English
• Subjects: Angioplasty, Balloon, Coronary; Anticholesteremic Agents - therapeutic use; Atherosclerosis; Biological and medical sciences; clinical trial; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - epidemiology; Coronary Artery Disease - therapy; Diet; Disease Progression; General and cellular metabolism. Vitamins; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Lipids - blood; lovastatin; Lovastatin - therapeutic use; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Prospective Studies; Recurrence; restenosis; Time Factors
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1053/euhj.1999.1483

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 (P50% 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.