A Double-Blind, Placebo-Controlled, Randomized Trial of Fluvastatin after Successful Percutaneous Intervention (PCI) in Patients with Coronary Heart Disease: The Lescol Intervention Prevention Study (LIPS)
Patrick W. Serruys
Erasmus University
Rotterdam,Netherlands

This is the first prospective trial showing statin therapy reduces major adverse cardiac events in patient who previously underwent a percutaneous coronary intervention. Fluvastatin reduced risk of events by 22% over 4 years. This finding supports the use of lipid lowering therapy in this patient population.

Percutaneous coronary interventions are successful in the short-term. However, patients who undergo these procedures are still at risk for subsequent cardiovascular events. An average of 40% of patients undergoing percutaneous coronary intervention will have a myocardial infarction, or require repeat intervention or bypass within 5 years.

The Lescol Intervention Prevention Study (LIPS) is the first prospective, double blind, placebo controlled study of statins in this population of patients who have undergone angioplasty and other interventional procedures.

Investigators from 57 centers in 10 countries enrolled a total of 1,677 patients (mean age 60 years, about 84% male) into the LIPS study. All patients had average cholesterol levels.

Patients received fluvastatin 40 mg twice daily or placebo after a first successful percutaneous coronary intervention. Follow-up was at least 3 years per patient. The primary endpoint was time to first major adverse coronary event, including cardiac death, nonfatal myocardial infarction, bypass or repeat percutaneous coronary intervention.

Fluvastatin treatment reduced the risk of major adverse cardiac events (MACE) 22% compared with placebo (P = 0.013). Risk ratios for all primary and secondary endpoints favored fluvastatin treatment.

In a prespecified analysis that excluded repeat intervention, risk reduction was 34% compared with placebo. Patients with diabetes, which comprised 12% of the study population, had a 47% reduction in risk of a serious cardiac event (P = 0.041). Patients with multivessel disease, or 37% of the study population, had a 34% reduction vs. placebo (P = 0.011).

Safety analysis suggested no significant elevations of creatine phosphokinase. A recent pooled analysis of 9,000 patients on fluvastatin found the rate of clinically relevant elevations in creatine phosphokinase was not significantly different than in patients on placebo.

The LIPS study demonstrates the value of starting lipid lowering therapy in patients who undergo cardiac interventions. The results also validate aggressive treatment of high risk patients with diabetes or multivessel disease.

Importantly, the findings support the recommendation to reduce low density lipoprotein cholesterol below 100 mg/dL in all patients who have had a percutaneous coronary intervention. This recommendation is part of the most recent guidelines from the National Cholesterol Education Program.


Reporter: Andrew Bowser