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 Cor onary 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 treat ment 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 g roup. 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 i n 78% and 43%. During the first year, 27 (2.2%) patients in the invasive gr oup and 48 (3.9%) in the non-invasive group died (risk ratio 0.57 [95% CI 0 .36-0.90], p=0.016). 105 (8.6%) versus 143 (11.6%) had myocardial infarctio n (0.74 [0.59-0.94], p=0.015). The composite of death or myocardial infarct ion 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 t he 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 patie nts with coronary-artery bypass grafting and 21 more with percutaneous tran sluminal angioplasty. Therefore, an invasive approach should be the preferr ed strategy in patients with unstable coronary-artery disease and signs of ischaemia on electrocardiography or raised levels of biochemical markers of myocardial damage.