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 Il 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.

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