INTERACT (long-term follow-up)

INTegrilin and Enoxaparin Randomized assessment of Acute Coronary syndrome Treatment trial (long-term follow-up) (2006)

Condition

Treatment of high-risk non-ST-segment elevation acute coronary syndromes

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Objective

To determine whether the short-term benefits of enoxaparin compared with UFH observed in high-risk patients with non-ST-segment elevation acute coronary syndromes receiving ASA and eptifibatide are maintained over a prolonged period of follow-up

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Trial design

Active treatment: enoxaparin 1 mg/kg s.c. twice daily (n=325)
Control treatment: UFH 70 IU/kg bolus followed by 15 IU/kg i.v. per hour adjusted to an aPTT of 1.5–2.0 times control for 48 hours (n=314)

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Endpoints

Primary efficacy endpoint: composite of death or non-fatal myocardial infarction
Secondary efficacy endpoints: occurrence of cardiac catheterization, coronary revascularization, and readmission to hospital for either unstable angina or congestive heart failure
Safety endpoint: non-CABG major bleeding

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Trial participants

639 patients of the total population of 746 subjects in the INTERACT trial were followed up. This trial randomized 746 patients with ischemic symptoms at rest within the past 24 hours, ST-segment deviation, and/or elevated serum biomarkers to receive either enoxaparin or UFH for a 30-days follow-up period. The results of this trial are summarized as “short-term outcome”

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Results

Short-term outcome: In the population of 746 patients, the incidence of death or myocardial infarction at 30 days was 44% lower in the enoxaparin-treated group compared with the UFH-treated group (5% vs. 9%). Non-CABG major bleeding was lower in the enoxaparin compared to the UFH group (1.8% vs. 4.6%)
Long-term outcome: The early benefit of enoxaparin at 30 days was maintained during longer-term follow-up. At a mean follow-up of 2.5 years, patients receiving enoxaparin had a significantly lower rate of death or myocardial infarction compared with those who received UFH (8.9% vs. 14.7%, relative risk reduction 39%). There was no difference in the frequency of cardiac catheterization in the groups receiving either enoxaparin or UFH. 38 patients died, 14 of 325 (4.3%) in the enoxaparin group and 25 of 314 (7.6%) in the UFH group

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Summary

Efficacy: In high-risk patients with non-ST-elevation acute coronary syndromes receiving concomitant ASA and eptifibatide, the early outcome benefit of enoxaparin over UFH is sustained with a 39% relative risk reduction in death or myocardial infarction over a prolonged follow-up period of 2.5 years
Safety: When cardiac catheterization is not performed in the first 24–48 hours the use of enoxaparin is associated with less serious bleeding

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Reference

Fitchett DH, Langer A, Armstrong PW, Tan M, Mendelsohn A, Goodman SG, for the INTERACT Trial Long-Term Follow-Up Investigators. Randomized evaluation of the efficacy of enoxaparin versus unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes receiving the glycoprotein IIb/IIIa inhibitor eptifibatide. Long-term results of the Integrilin and Enoxaparin Randomized Assessment of Acute Coronary Syndrome Treatment (INTERACT) trial. Am Heart J 2006;151:373-379

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Corresponding author

David H. Fitchett, MD, Room 6032, St Michael’s Hospital, 30 Bond St, Toronto, Ontario, Canada M4V 1W5, e-mail: fitchettd@smh.toronto.on.ca

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