Copyright © 2002 by the European Society of Cardiology.
Effect of fluvastatin on ischaemia following acute myocardial infarction: a randomized trial
a Oosterschelde Ziekenhuizen, Goes, The Netherlands
b University Hospital, Groningen, The Netherlands
Trial Coordination Centre (TCC), Groningen, The Netherlands
c Reinier de Graaf Gasthuis, Delft, The Netherlands
d Leyenburg Ziekenhuis, Den Haag, The Netherlands
e Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
revised April 16, 2002; accepted April 17, 2002
Abstract
Aims Residual ischaemia following acute myocardial infarction (AMI) is related to an adverse outcome, although the effect of early initiation of statin therapy is unknown.
Methods A randomized, placebo-controlled, double-blind, parallel study was performed, which compared fluvastatin 80mg daily with placebo in patients with an AMI and total cholesterol of <6·5mmol.l–1. Ischaemia was measured by ambulatory electrocardiographic (AECG) monitoring over 48-h at baseline, after 6 weeks and at 12 months.
Results Five hundred and forty patients were included (83% male, age 61±11 years); 43% had an anterior AMI and 50% were treated with fibrinolytics in the acute phase. After 12 months, the total cholesterol (TC) level was reduced by 13% and LDL-C (low-density-lipoprotein cholesterol) by 21% (from 3·5mmol.l–1 to 2·7mmol.l–1) in the fluvastatin treatment group. Both TC and LDL increased by 9% in the placebo group (P<0·001 between groups). At baseline, ischaemia on AECG was present in only 11% of patients, and absent in 77%; in the remaining 11%, recordings were technically inadequate. After 6 weeks, 32/48 (67%), and 12 months 35/46 (76%) of the patients with ischaemia on the baseline AECG, no longer showed signs of ischaemia. Nevertheless, ischaemia at baseline was predictive for the occurrence of any major clinical event (RR=2·35; 95% CI 1·39–3·2;P <0·001). Fluvastatin treatment did not affect ischaemia on AECG, nor the occurrence of any major clinical events as compared to placebo. Post-hoc analysis in patients with the most pronounced ischaemia at baseline showed a trend for a beneficial effect of fluvastatin on major clinical events (P=0·084).
Conclusion Residual ischaemia after AMI is observed less frequently in the present study, than in earlier studies, although it is predictive for future cardiovascular events. As a result, the present study was underpowered, and no effect of fluvastatin on AECG ischaemia, or major clinical events in the first year after AMI, could be detected. The present data do not confirm other reports which support widespread use of statin treatment early after AMI. Copyright 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.
Key Words: Myocardial ischaemia, acute coronary syndrome, fluvastatin, statin, ambulatory electrocardiographic monitoring.
f1 Correspondence: Prof. Dr D. J. van Veldhuisen, Department of Cardiology/Thoraxcenter, University Hospital Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands.
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