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June 27, 2002 — Fluvastatin, a cholesterol-lowering drug, may help reduce the risk of major adverse cardiac events in patients with average cholesterol levels who have undergone a percutaneous coronary intervention (PCI, such as coronary artery balloon angioplasty), according to an article in the June 26 issue of The Journal of the American Medical Association (JAMA).
Patrick W. J. C. Serruys, M.D., Ph.D., of the Academic Hospital, Rotterdam, the Netherlands, and colleagues investigated whether administering fluvastatin after a first PCI procedure could reduce the risk of another major cardiac event. PCI encompasses a group of procedures used to widen arteries that have narrowed due to a buildup of plaques. Balloon angioplasty, with or without stent placement, is a common procedure, with 1.1 million procedures performed in 1999 in the United States.
According to background information given in the article, "3 of 5 patients at 5 years [after a first PCI procedure], and only 1 of 3 patients at 10 years remain free of major adverse cardiac events." Major cardiac events were defined as cardiac death, non-fatal heart attack, or the need for another coronary procedure including coronary bypass surgery or repeat PCI. Previous studies have suggested that taking a statin, or lipid-lowering drug, may help reduce the risk of major cardiac events after PCI.
The authors enrolled 1,677 patients in the Lescol Intervention Prevention Study (LIPS), a randomized trial testing the benefits of early intervention with lipid-lowering therapy using fluvastatin in patients undergoing their first PCI. The patients, aged 18 to 80 years, were recruited between April 1996 and October 1998, had stable or unstable angina or silent ischemia and had successful completion of their first PCI. In the study, 98 percent of patients had a balloon angioplasty with or without stent placement.
Participants were given either fluvastatin (80 mg/d) or placebo within an average of two days after a successful first-time PCI procedure. The patients were followed up six weeks after receiving either fluvastatin or placebo, and then every six months for the duration of the study, for an average of 3.9 years.
The authors found that "181 (21.4 percent) of the 844 patients in the fluvastatin group and 222 (26.7 percent) of the 833 placebo controls had at least one major adverse cardiac event, resulting in a statistically significant reduction in risk [22 percent] of major cardiac event for fluvastatin compared with placebo."
The authors conclude that their study supports the early use of lipid-lowering drugs in patients who have undergone PCI, regardless of baseline lipid level.
Editor's Note: This study was supported by a grant from Novartis Pharma AG. Novartis provided the fluvastatin and matching placebo used in this study. For the role of the sponsor in the study, please see the JAMA article.