The correlation between statin treatment and outcome, which was observed even in patients with normal baseline cholesterol levels, was found in the Lescol Intervention Prevention Study (or LIPS): This international trial involved over 1,600 patients and was the first prospective statin study in the setting of angioplasty.

"[This study] provides us with the scientific foundation to change the way we treat patients who undergo percutaneous coronary intervention, such as angioplasty or other similar procedures," commented lead author and principal investigator Patrick Serruys, MD, PhD, of the Netherlands. "The study supports early intervention with fluvastatin in post-percutaneous coronary intervention patients, regardless of cholesterol levels, to help prevent fatal and non fatal cardiac events such as heart attacks and coronary surgery."

Study data indicate that use of fluvastatin prevented one fatal or non-fatal major adverse coronary event in 1 of every 19 people treated for four years. With an average low-density cholesterol level of 132 mg/dL [3.4 mmol/L] at entry into the study, half of the participants had a baseline cholesterol level within the normal range. The risk reduction following fluvastatin therapy was similar regardless of baseline cholesterol levels. Because of this, the authors concluded that statin therapy after percutaneous coronary intervention should be based on an overall risk assessment of the patient rather than simply baseline cholesterol level.

The current study is the first prospective, randomized, placebo-controlled trial to evaluate the effects of a statin exclusively in patients who have had a first percutaneous intervention procedure. The trial involved 1,677 patients recruited from 57 centers in 10 countries (in Europe, Canada, and Brazil) who were followed for four years after their first intervention procedure. Study outcome was duration until first major adverse cardiac event. Major adverse cardiac events were defined as cardiac death, nonfatal myocardial infarction, coronary artery bypass grafting, or repeat percutaneous intervention.

Patients were randomized to begin treatment with fluvastatin 80 mg/day (40 mg twice daily) or placebo before hospital discharge. Study data demonstrate that fluvastatin treatment significantly reduced the risk of major adverse cardiac events by 22 percent compared with the risk for patients given placebo.

In addition, the benefits of statin therapy were even more profound for certain high-risk subgroups. Patients with diabetes experienced a 47 percent reduction in risk, and patients with multi-vessel disease experienced a 34 percent reduction in risk. Patients who had a stent implanted and those without stents experienced similar benefits of statin therapy. Among all statin-treated patients, those with unstable angina experienced a greater risk reduction than those with stable angina (28 percent versus 20 percent, respectively). Levels of low-density cholesterol were significantly reduced with statin therapy to mean levels below 100 mg/dL (2.6 mmol/L) over the course of the study.