FRISC-II

Fast Revascularization during InStability in Coronary artery disease - II (1999, 2006)

Condition

Treatment of unstable coronary artery disease

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Objective

To compare an early invasive with a non-invasive primarily medical strategy in patients with unstable coronary artery disease in addition to optimum background antithrombotic medication

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Trial design

Prospective, randomized, open (invasive/non-invasive approach) and double-blind, placebo-controlled (prolonged dalteparin) study with parallel groups:

  • invasive treatment plus dalteparin (n=611)
  • invasive treatment plus placebo (n=611)
  • non-invasive treatment plus dalteparin (n=621)
  • non-invasive treatment plus placebo (n=614)

Active treatment: early invasive strategy (coronary angiography and, if appropriate, revascularization, within 7 days from admission); dalteparin 7500 IU s.c. twice daily (n=1222)
Control treatment: dalteparin 7500 IU s.c. twice daily; placebo (n=1235)

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Endpoints

Primary efficacy endpoint: composite of death, myocardial infarction, or both at 6 months and 5 years
Secondary efficacy endpoints: death, myocardial infarction, late revascularization, readmissions to hospital, and cardiac symptoms at 6, 12, and 24 months

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Trial participants

2457 patients (median age 66 years, 70% men) admitted with symptoms of myocardial ischemia or non-ST-elevation myocardial infarction with the last episode of chest pain within 48 hours before start of treatment

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Results

Efficacy outcome at 6 months: After 6 months, the composite endpoint of death or myocardial infarction had occurred in 9.4% of the invasive treated patients compared with 12.1% in the non-invasive treated group (relative risk reduction 22%). The rate of myocardial infarction was significantly lower in the invasive group (7.8% vs. 10.1%) and the mortality was non-significantly lower (1.9% vs. 2.9%) in the invasive group. Symptoms of angina and re-admission were halved by the invasive strategy. Results were indpendent of the randomized dalteparin treatments
Efficacy outcome at 5 years: At 5 years, the differences remained between the groups: Death or myocardial infarction were less frequent in the invasive than in the non-invasive group (19.9% vs. 24.5%; relative risk reduction 19%). 5-year mortality was 9.7% in the invasive group compared with 10.1% in the non-invasive group. Rates of myocardial infarction were 12.9% and 17.7%, respectively

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Summary

The 5-year outcome indicates sustained benefit of an early invasive strategy compared with a non-invasive approach in patients with non-ST-elevation acute coronary syndromes at moderate to high risk. The benefit of the invasive strategy was confined to male patients, non-smokers, and patients with two or more risk indicators

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Reference

(1) FRagmin and Fast Revascularisation during InStability in Coronary artery disease Investigators. Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC-II prospective randomised multicentre study. Lancet 1999;354:708-15
(2) Lagerqvist B, Husted S, Kontny F, Ståhle E, Swahn E, Wallentin L. 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

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Corresponding author

Prof. Lars Wallentin, MD, Department of Cardiology and Uppsala Clinical Research Center, University Hospital, S-751 85 Uppsala, Sweden, e-mail: lars.wallentin@ucr.uu.se

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