Principal Findings:

In the fluvastatin group, LDL cholesterol decreased by 37% within the first 2 weeks of therapy before angioplasty was performed, whereas in the placebo group no significant change occurred. At 6 months, serum LDL cholesterol was 33% lower than at baseline in the fluvastatin group, whereas in the placebo group there was no change in LDL. There were no significant changes in HDL, apolipoprotein A1 or lipoprotein (a) levels. An increase in serum ALAT >3 times the upper limit was observed in 1.7% and 0.7% of the fluvastatin and placebo group, respectively. Fluvastatin had no effect on minimum lumen diameter after 26 weeks (1.55 +/- 0.59mm in the fluvastatin and 1.53 +/- 0.58mm in the placebo group; p=0.77). Restenosis (>50% diameter stenosis) occurred in 28% of the fluvastatin group vs. 31% in the placebo group (p=0.42). Major cardiac events (death, myocardial infarction, coronary artery bypass surgery, or repeated angioplasty) within 40 weeks occurred in 22.4% in the fluvastatin group vs. 23.3% patients in the placebo group (log rank p=0.74). Mortality was 0.7% in the fluvastatin group vs. 1.6% in the placebo group (p=0.37). However, the combined incidence of death and myocardial infarction was 1.4% in the fluvastatin group vs. 4.0% in the placebo group (log rank p=0.025).