Fluvastatin in Acute Myocardial Infarction: Effects on Early and Late Ischemia and Events: the FLORIDA Trial
In post-myocardial infarction (MI) patients, residual ischemia is related to an adverse clinical outcome. Thus, early initiation of statin treatment may be particularly beneficial after MI. The “FLuvastatin On RIsk Diminishing after Acute myocardial infarction” (FLORIDA) trial is a prospective, placebo-controlled multicenter trial, designed to study the effect of Fluvastatin 80 mg per day on post-MI ischemia on 48 hours ambulatory ECG monitoring (AECG) and major adverse cardiac events (MACE). Included were 540 patients (83% male, age 61± 11 yrs) with an acute myocardial infarction (43% anterior) and a cholesterol value <6.5 mmol/L (mean 5.4± 0.7). AECGs were performed during admission for MI, after 6 weeks and 12 months. Fluvastatin 80 mg/day or placebo were administered during admission and for one year. Events were adjudicated by a blinded monitoring committee. After 12 months treatment, fluvastatin lowered LDL cholesterol from 3.5 to 2.7 mmol/L and placebo from 3.6 to 3.9 mmol/L (p<0.001). At baseline, 6 weeks and 12 months ischemia on AECG was present in 12%, 8% and 6% of the patients on fluvastatin and in 13%, 6% and 10% of the patients on placebo (p=ns). On fluvastatin the ischemic burden (±sem) was 13±4, 5±2, and 2±1 mm∗min and on placebo 16±6, 5±3, and 3±1 mm∗min (p=ns). After 12 months, MACE and residual AECG ischemia occurred in 30% of fluvastatin patients and in 36% of placebo patients (p=ns). For this combined endpoint, ischemia at baseline was highly predictive (OR 2.92, 95% CI 1.61–5.29, p= 0.0004). One-year mortality was 2.6% on fluvastatin and 4.0 % on placebo (p=ns). A trend toward a beneficial effect of fluvastatin on MACE was observed in patients with severe ischemia at baseline (p=0.08). Conclusion. Post-MI ischemia on AECG was highly predictive for adverse outcome after one year. Fluvastatin had no beneficial effect on post-MI ischemia after 6 weeks or 12 months. Although not powered for this purpose, this study showed no effect of fluvastatin on MACE. A positive trend though, was observed in patients with severe ischemia at baseline.
- Copyright © 2000 by American Heart Association