ArticlesOutcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: the FRISC II invasive randomised trial
Introduction
Invasive procedures have become increasingly common early after an episode of unstable coronary-artery disease, even in patients who are clinically stabilised.1 The 6-month results of the FRISC II (Fast Revascularisation during Instability in Coronary artery disease) invasive trial2 showed a reduction in the composite endpoint of death or myocardial infarction with an invasive strategy in patients with unstable coronary-artery disease and signs of ischaemia as shown by electrocardiography (ECG) or rises in biochemical markers of myocardial damage. These results provoked much debate because two previous large-scale randomised trials had not shown similar results.3, 4 The FRISC II medical trial showed that, within the non-invasive strategy group, extended treatment with dalteparin for 3 months significantly lowered the risk of death, myocardial infarction, and need for revascularisation; thus, this approach might be an alternative strategy.5 The endpoint of myocardial infarction could be invalid because detection, definition, and impact of myocardial infarction differ according to whether it occurs during revascularisation procedures (as in most events in the group treated by the invasive strategy) or spontaneously (as in most events in the group treated non-invasively). Thus, further documentation was needed of the results of the invasive versus non-invasive comparison in the FRISC II trial for mortality only, long-term risk of myocardial infarction, and the long-term outcome among patients treated with dalteparin or placebo. The outcome of the continued follow-up will influence whether the FRISC II invasive trial changes the current treatment guidelines for unstable coronary-artery disease, which will have important consequences for management of patients and for treatment costs. We report here the 1-year results of the randomised invasive versus non-invasive strategy in terms of death, myocardial infarction, and the need for readmission and revascularisation procedures and the outcome in the long-term dalteparin versus placebo cohorts and in predefined subgroups based on commonly used risk indicators.
Section snippets
Patients
Patients were eligible for inclusion if they had symptoms of ischaemia that were increasing or occurring at rest or raised the suspicion of acute myocardial infarction, with the last episode preceding the first dose of dalteparin or standard heparin by less than 48 h. Furthermore, myocardial ischaemia had to be verified by ECG (ST-segment depression ≥0·1 mV or T-wave inversion ≥0·1 mV), or by raised biochemical markers (creatine kinase MB isoenzyme >6 μg/L, troponin T ≥0·10 μg/L, qualitative
Characteristics of patients and procedures done
2457 patients were randomly assigned the invasive or the non-invasive regimen and 3 months' treatment with dalteparin or placebo. In January, 2000, complete information on vital status was available from 2456 patients with a last contact at least 335 days after randomisation. We lacked information on vital status and myocardial infarction at 12 months for one patient from the non-invasive group and information on myocardial infarction for three patients in the invasive group because of
Discussion
The most important new finding in this 1-year follow-up of the invasive versus non-invasive comparison in the FRISC II trial is the significant and clinically relevant absolute and relative reductions in 1-year mortality when an invasive strategy is adopted. Furthermore, the survival analysis indicates a continuously increasing separation of the event rates. The 1-year follow-up documents a treatment alternative—the invasive strategy—that is able to reduce long-term mortality in unstable
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