CONTEXT: Percutaneous coronary intervention (PCI) is associated with excellent 
short-term improvements in ischemic symptoms, yet only three fifths of PCI 
patients at 5 years and one third of patients at 10 years remain free of major 
adverse cardiac events (MACE).
OBJECTIVE: To determine whether treatment with fluvastatin reduces MACE in 
patients who have undergone PCI.
DESIGN AND SETTING: Randomized, double-blind, placebo-controlled trial conducted 
at 77 referral centers in Europe, Canada, and Brazil.
PATIENTS: A total of 1677 patients (aged 18-80 years) recruited between April 
1996 and October 1998 with stable or unstable angina or silent ischemia 
following successful completion of their first PCI who had baseline total 
cholesterol levels between 135 and 270 mg/dL (3.5-7.0 mmol/L), with fasting 
triglyceride levels of less than 400 mg/dL (4.5 mmol/L).
INTERVENTIONS: Patients were randomly assigned to receive treatment with 
fluvastatin, 80 mg/d (n = 844), or matching placebo (n = 833) at hospital 
discharge for 3 to 4 years.
MAIN OUTCOME MEASURE: Survival time free of MACE, defined as cardiac death, 
nonfatal myocardial infarction, or reintervention procedure, compared between 
the treatment and placebo groups.
RESULTS: Median time between PCI and first dose of study medication was 2.0 
days, and median follow-up was 3.9 years. MACE-free survival time was 
significantly longer in the fluvastatin group (P =.01). One hundred eighty-one 
(21.4%) of 844 patients in the fluvastatin group and 222 (26.7%) of 833 patients 
in the placebo group had at least 1 MACE (relative risk [RR], 0.78; 95% 
confidence interval [CI], 0.64-0.95; P =.01). This result was independent of 
baseline total cholesterol levels (above [RR, 0.76; 95% CI, 0.56-1.04] vs below 
[RR, 0.77; 95% CI, 0.57-1.02] the median). In subgroup analysis, the risk of 
MACE was reduced in patients with diabetes (n = 202; RR, 0.53; 95% CI, 
0.29-0.97; P =.04) and in those with multivessel disease (n = 614; RR, 0.66; 95% 
CI, 0.48-0.91; P =.01) who received fluvastatin compared with those who received 
placebo. There were no instances of creatine phosphokinase elevations 10 or more 
times the upper limit of normal or rhabdomyolysis in the fluvastatin group.
CONCLUSION: Fluvastatin treatment in patients with average cholesterol levels 
undergoing their first successful PCI significantly reduces the risk of major 
adverse cardiac events.