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
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
Conclusion Fluvastatin treatment in patients with average cholesterol levels undergoing
their first successful PCI significantly reduces the risk of major adverse