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)

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 300 mg.dl-1 who 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 33 mg.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 0.3 mm in the usual care group and 0.004 mm in the special care group (P = 0.27). The decrease in the mean segment diameter of dilated lesions was 0.17mm (usual care) and 0.06 mm (special care) (P = 0.04) after 4 months; 0.16 mm (usual care) and 0.002 mm (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 followup. Four weeks of pre-treatment with lovastatin did not influence the rate of restenosis. Lovastatin had no statistically significant effect on non-dilated segments.