ACC: Fluvastatin Decreases Risk of Major Acute Coronary Events After Angioplasty With or Without Stents
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ACC: Fluvastatin Decreases Risk of Major Acute Coronary Events After Angioplasty With or Without Stents

By Ed Susman

CHICAGO, IL -- April 4, 2003 -- Patients undergoing angioplasty -- whether or not they receive a stent -- benefit from taking fluvastatin (Lescol) after the percutaneous procedure.

"In a prespecified analysis which excluded re-interventions due to target lesion revascularization in the first 6 months of follow-up, treatment with fluvastatin reduced the risk of major adverse cardiac events by 28% in the group of patients who received a stent and by 39% in the patients who were given a balloon angioplasty without the stent," said Francesco Saia, MD, a research fellow at the Erasmus Medical Center, The Netherlands.

Dr. Saia presented the results in a poster session here March 30th at the 52nd Annual Scientific Session of the American College of Cardiology.

He said those results, derived from scrutiny of the Lescol Intervention Prevention Study (LIPS), achieved statistical significance at the P=0.02 level in the stent group and at the P=0.01 level in the balloon group of patients.

Overall in LIPS, the treatment with fluvastatin resulted in a 22% decrease in major adverse cardiac events in patients who had undergone a successful percutaneous procedure, Dr. Saia noted.

"When restenosis was excluded," he said, "fluvastatin treatment was associated with a significant reduction in major adverse cardiac events in both treatment groups, a finding consistent with the hypothesis that most of the benefit of statin therapy derives from effects on the underlying atherosclerosis."

Aside from 6-month target vessel revascularization, there were 23 events among the placebo patients who underwent balloon angioplasty but did not receive a stent, compared with 15 events in the patients who were in the fluvastatin arm of the study. Overall, 582 patients underwent angioplasty alone.

Among the 1,055 patients who underwent angioplasty and stent emplacement, 22 patients experienced a major adverse cardiac event -- other than 6-month target vessel revascularization, while 17 patients who were on fluvastatin suffered such an event. There were 2 more deaths in the placebo arms of each group, but the overall death rate was low and there was not a statistical difference in mortality, Dr. Saia said.

LIPS was funded by Novartis Pharmaceutical Corporation.

[Study title: Early Fluvastatin Treatment Reduces the Long-Term Incidence of Major Adverse Cardiovascular Events Following Successful First Percutaneous Coronary Intervention With or Without the Use of Stent: The Lescol(r) Intervention Prevention Study. Abstract: 1010-146]

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