Outcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: the FRISC II invasive randomised trial

Background The Fragmin and Fast Revascularisation during Instability in Coronary artery disease II trial (FRISC II) compared an early invasive with an early non-invasive strategy in unstable coronary-artery disease. We report outcome at 1 year. Methods 2457 patients were randomly assigned invasive or non-invasive treatment and 3 months of dalteparin or placebo. Complete information at 1 year was available for 1222 in the invasive group and 1234 in the non-invasive group. Analyses were by intention to treat. Findings Revascularisation was done within the first 10 days in 71% of the invasive group and 9% of the non-invasive group and within the first year in 78% and 43%. During the first year, 27 (2·2%) patients in the invasive group and 48 (3·9%) in the non-invasive group died (risk ratio 0·57 [95% Cl 0·36–0·90], p=0·016). 105 (8·6%) versus 143 (11·6%) had myocardial infarction (0·74 [0·59–0·94], p=0·015). The composite of death or myocardial infarction occurred in 127 (10·4%) versus 174 (14·1%) patients (0·74 [0·60–0·92], p=0·005). There were also reductions in readmission (451 [37%] vs 704 [57%]; 0·67 [0·62–0·72]), and revascularisation after the initial admission (92 [7·5%] vs 383 [31%]; 0·24 [0·20–0·30]). The results did not interact with the dalteparin/placebo allocation. Interpretation After 1 year in 100 patients, an invasive strategy saves 1·7 lives, prevents 2·0 non-fatal myocardial infarctions and 20 readmissions, and provides earlier and better symptom relief at the cost of 15 more patients with coronary-artery bypass grafting and 21 more with percutaneous transluminal angioplasty. Therefore, an invasive approach should be the preferred strategy in patients with unstable coronary-artery disease and signs of ischaemia on electrocardiography or raised levels of biochemical markers of myocardial damage.