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Lescol Intervention Prevention Study - LIPS
Description:
The goal of the LIPS trial was to compare the effects of fluvastatin with placebo on cardiac outcomes in patients undergoing PCI.
Hypothesis:
Use of the statin fluvastatin following first PCI would result in a 25% relative reduction in MACE at 3 years.
Study Design
Study Design:
Patients Enrolled: 1,677
Mean Follow Up: 3-4 years (median 3.9 years)
Mean Patient Age: mean 60 years
Female: 16
Mean Ejection Fraction: Mean ejection fraction at baseline was 62% in both groups
Patient Populations:
Age 18-80 years Successful first PCI of 1 or more lesions Not on lipid lowering therapy during 6 weeks pre-randomization Baseline cholesterol 135-270 mg/dL
Primary Endpoints:
MACE (cardiac death/MI/CABG/repeat PCI) free survival time during 3-4 year follow-up
Secondary Endpoints:
cardiac death non-cardiac death death death or non-fatal MI cardiac death or non-fatal MI lipid profile safety and tolerability
Drug/Procedures Used:
Patients were randomized to fluvastatin (40 mg twice daily, n=844) or placebo (n=833) for 3-4 years. First dose given an average of 2 days after successful PCI.
Principal Findings:
LDL levels fell below 100 mg/dL in the fluvastatin group for most of the 4-year follow-up period, unlike the placebo arm. MACE event-free survival was higher in the fluvastatin arm by 4 year follow-up (26.7% vs 21.4%, RR 0.78, 95% CI 0.64-0.95; p=0.01), and the reduction was found to be independent of baseline total cholesterol levels. The event curves began to diverge after approximately 1.5 years. MACE was significantly reduced with the use of fluvastatin in the multivessel disease subgroup (RR 0.66, 95% CI 0.48-0.91; p=0.01) and the diabetic subgroup (RR 0.53, 95% CI 0.29-0.97; p=0.04). The fluvastatin arm tended to be associated with lower rates of cardiac death (1.5% vs 2.9%, p=0.060) and cardiac death/MI (5.0% vs 7.2%, p=0.052).
Interpretation:
Among patients undergoing PCI, treatment with fluvastatin was associated with a reduction in the primary endpoint of event free survival at 4 years of follow-up compared with placebo. Other retrospective substudies such as the CARE trial showed a reduction in ischemic events with statin therapy following PCI, but LIPS was the first prospective statin cardiac outcome trial to exclusively study the post PCI population. The earlier randomized Fluvastatin Angiographic Restenosis (FLARE) study did not show a reduction in the primary endpoint of angiographic restenosis with fluvastatin but did show a reduction in the secondary endpoints of death or MI.
References:
JAMA. 2002; 287:3215-3222. Presented at ACC 51st Scientific Sessions, Atlanta, GA
Keywords: Cholesterol, Follow-Up Studies, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Indoles, Fatty Acids, Monounsaturated, Disease-Free Survival, Diabetes Mellitus
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