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Original Contribution
June 26, 2002

Fluvastatin for Prevention of Cardiac Events Following Successful First Percutaneous Coronary Intervention: A Randomized Controlled Trial

Author Affiliations

Author Affiliations: Interventional Cardiology, Thoraxcenter, Academic Hospital, Rotterdam, the Netherlands (Drs Serruys and de Feyter); Cardiology Department, Hospital San Carlos, Madrid, Spain (Dr Macaya); Cardiology Department, Hopital Purpan, Toulouse, France (Dr Puel); Cardiology Department, St Jan Hospital, Genk, Belgium (Dr Vrolix); Cardiology Department, Ospedale Santa Orsola, Bologna, Italy (Dr Branzi); Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil (Dr Bertolami); Cardiology Department, Guys Hospital, London, England (Dr Jackson); Division of Cardiology, St Michaels Hospital, Toronto, Ontario (Dr Strauss); Medical Department, Cardiology, University Hospital Insel, Bern, Switzerland (Dr Meier). Dr Kokott is in cardiological private practice affiliated with Koepenick Hospital, Berlin, Germany.

JAMA. 2002;287(24):3215-3222. doi:10.1001/jama.287.24.3215

Context Percutaneous coronary intervention (PCI) is associated with excellent short-term improvements in ischemic symptoms, yet only three fifths of PCI patients at 5 years and one third of patients at 10 years remain free of major adverse cardiac events (MACE).

Objective To determine whether treatment with fluvastatin reduces MACE in patients who have undergone PCI.

Design and Setting Randomized, double-blind, placebo-controlled trial conducted at 77 referral centers in Europe, Canada, and Brazil.

Patients A total of 1677 patients (aged 18-80 years) recruited between April 1996 and October 1998 with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL (3.5-7.0 mmol/L), with fasting triglyceride levels of less than 400 mg/dL (4.5 mmol/L).

Interventions Patients were randomly assigned to receive treatment with fluvastatin, 80 mg/d (n = 844), or matching placebo (n = 833) at hospital discharge for 3 to 4 years.

Main Outcome Measure Survival time free of MACE, defined as cardiac death, nonfatal myocardial infarction, or reintervention procedure, compared between the treatment and placebo groups.

Results Median time between PCI and first dose of study medication was 2.0 days, and median follow-up was 3.9 years. MACE-free survival time was significantly longer in the fluvastatin group (P = .01). One hundred eighty-one (21.4%) of 844 patients in the fluvastatin group and 222 (26.7%) of 833 patients in the placebo group had at least 1 MACE (relative risk [RR], 0.78; 95% confidence interval [CI], 0.64-0.95; P = .01). This result was independent of baseline total cholesterol levels (above [RR, 0.76; 95% CI, 0.56-1.04] vs below [RR, 0.77; 95% CI, 0.57-1.02] the median). In subgroup analysis, the risk of MACE was reduced in patients with diabetes (n = 202; RR, 0.53; 95% CI, 0.29-0.97; P = .04) and in those with multivessel disease (n = 614; RR, 0.66; 95% CI, 0.48-0.91; P = .01) who received fluvastatin compared with those who received placebo. There were no instances of creatine phosphokinase elevations 10 or more times the upper limit of normal or rhabdomyolysis in the fluvastatin group.

Conclusion Fluvastatin treatment in patients with average cholesterol levels undergoing their first successful PCI significantly reduces the risk of major adverse cardiac events.