In ACS, 5 yrs of invasive tx decreases MI but not all cause mortality (FRISC-II)

Clinical Question

Are the long-term outcomes of invasive intervention better than those for medical management in the face of acute coronary syndromes?

Bottom Line

In this study of patients with non-ST-elevation acute coronary syndromes, patients treated invasively had fewer subsequent myocardial infarctions after 5 years than patients treated medically. The benefits are seen mainly in men, nonsmokers, and patients with at least 2 risk factors. (LOE = 1b)

Reference

Lagerqvist B, Husted S, Kontny F, et al, for the Fast Revascularisation during InStability in Coronary artery disease (FRISC-II) Investigators. 5-year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study. Lancet 2006;368:998-1004.  [PMID:16980115]

Study Design

Randomized controlled trial (nonblinded)

Funding

Industry + govt

Allocation

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

The FRISC-II was a randomized trial designed to study the effects of invasive intervention or medical management of patients with acute coronary syndromes. This study reports the 5-year follow up on more than 99% of the original participants. The patients were eligible if they had less than 48 hours of chest pain with signs of myocardial ischemia or non-ST-elevation myocardial infarction. All patients received aspirin and dalteparin for at least 5 days. Those in the intervention group received aspirin and dalteparin every day until their revascularization; their last dose was the evening before the procedure. Patients also received beta-blockers unless contraindicated. During the first 24 months, the study team directly contacted patients. After this, the data for vital status were obtained from national population registries and the national registries of cause of death. The researchers used intention-to-treat analysis to analyze the outcomes. At the end of 5 years, there was no difference in all-cause morality (9.7% in the group managed invasively; 10.1% in the group managed medically). However, the patients managed invasively had fewer myocardial infarctions (12.9% vs 17.7%; number needed to treat = 21; 95% CI, 13-56). The benefit was seen mainly in men, nonsmokers, and patients with 2 or more risk factors.
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