Abstract 2078: 5-Year Follow-Up on the Protective Effects of an Early Invasive Strategy in Non-ST-Elevation Acute Coronary Syndrome in the FRISC II Study
The FRISC II trial compared an early invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome (NSTE-ACS). It was the first to demonstrate a reduction of the primary composite of death and myocardial infarction (MI) including the two individual components for up to two years. This report presents the follow-up on mortality and re-infarction over at least 5 years.
Methods: Between June 17, 1996, and August 28, 1998, 2457 patients with non-STE-ACS were randomized to an early invasive or non-invasive strategy in 58 Scandinavian hospitals. Revascularisation was performed within 10 days in 71% and 9%, after 1 year 78% and 43% and after 5 year in 80% and 51% of the respective invasive and non-invasive groups. The patients were evaluated concerning outcome events by outpatient visits until 6 months and by telephone contacts until 24 months. Thereafter follow up for the Swedish patients (79% of the material) were obtained by merging the FRISC-II data-base with the National Registries on Cause of Death and Hospital Admission which allowed a complete follow-up until December 2003. (The material will over the next months be complemented also with individual follow-up of the remaining 21 % of patients from other countries.) Results in the Swedish cohort at 5 years:
Conclusions: In NSTE-ACS an early invasive approach leads to a significant reduction in the composite of death and MI which is sustained over 5 years. The significance of the difference in total mortality is eroded over time because of a similar and important rate of non-cardiac deaths in both arms of the trial. The significant difference in the rate of MI is sustained over time. The lack of further separation in event rates during later years might be explained by the cross-over to an invasive strategy in around half of the non-invasive cohort within the first year. Thus, the long-term results of the FRISC-II trial support the benefits of an early invasive strategy in NSTE-ACS.