Fluvastatin Angioplasty Restenosis - FLARE
To evaluate the ability of fluvastatin 40mg twice daily to reduce restenosis after successful single lesion PTCA in non-hyperlipidemic patients.
Patients Screened: Not given
Patients Enrolled: 1054
Successful single lesion PTCA; non-hyperlipidemic patients (LDL<6mmol/L)
MI within previous 3 months; restenotic lesions; lesions in bypass graft; patiets requiring urgent revascularization; those with a fasting trglyercides >4.5mmol/L.
Death, MI, CABG or re-intervention up to 40 weeks after PTCA; restenosis at 6 months
Randomization to fluvastatin 40mg bid or placebo. Patients started study medication within 2 weeks before scheduled procedure. Those who had successful PTCA without reaching a major adverse cardiac event continued therapy for 26 +/- 2 weeks after angio.
In the fluvastatin group, LDL cholesterol decreased by 37% within the first 2 weeks of therapy before angioplasty was performed, whereas in the placebo group no significant change occurred. At 6 months, serum LDL cholesterol was 33% lower than at baseline in the fluvastatin group, whereas in the placebo group there was no change in LDL. There were no significant changes in HDL, apolipoprotein A1 or lipoprotein (a) levels. An increase in serum ALAT >3 times the upper limit was observed in 1.7% and 0.7% of the fluvastatin and placebo group, respectively. Fluvastatin had no effect on minimum lumen diameter after 26 weeks (1.55 +/- 0.59mm in the fluvastatin and 1.53 +/- 0.58mm in the placebo group; p=0.77). Restenosis (>50% diameter stenosis) occurred in 28% of the fluvastatin group vs. 31% in the placebo group (p=0.42). Major cardiac events (death, myocardial infarction, coronary artery bypass surgery, or repeated angioplasty) within 40 weeks occurred in 22.4% in the fluvastatin group vs. 23.3% patients in the placebo group (log rank p=0.74). Mortality was 0.7% in the fluvastatin group vs. 1.6% in the placebo group (p=0.37). However, the combined incidence of death and myocardial infarction was 1.4% in the fluvastatin group vs. 4.0% in the placebo group (log rank p=0.025).
Fluvastatin 80 mg/d, started 2 weeks before elective coronary angioplasty and continued for 26 weeks did not reduce the rate of restenosis, however, it reduced the incidence of the combined end point of death and myocardial infarction.
Am J Cardiol 1994;73:50D-61D Eur Heart J 1999;20:58-69
Keywords: Myocardial Infarction, Lipoprotein(a), Cholesterol, LDL, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Indoles, Fatty Acids, Monounsaturated, Apolipoprotein A-I, Constriction, Pathologic, Coronary Artery Bypass, Angioplasty, Balloon, Coronary
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