TIMI 11B

Thrombolysis In Myocardial Infarction (1999)

Condition

Treatment of unstable angina or non-Q-wave myocardial infarction

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Objective

To determine whether treatment with enoxaparin is superior to UFH for preventing events in the acute phase, and whether there is a potential benefit for enoxaparin administration for an additional 35 days after hospital discharge

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Trial design

Randomized, double-blind placebo-controlled study
Active treatment: enoxaparin during the acute phase (initial 30 mg i.v. bolus followed by 1.0 mg/kg s.c. every 12 hours) and outpatient phase (40 mg s.c. for patients weighing <65 kg and 60 mg s.c. for those weighing ≥65 kg every 12 hours) plus UFH-matching placebo; ASA 100–325 mg once daily for the entire follow-up (n=1953)
Control treatment: weight-adjusted UFH i.v. for ≥3 days and enoxaparinmatching placebo followed by placebo s.c.; ASA 100–325 mg once daily for the entire follow-up (n=1957)

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Endpoints

Primary efficacy endpoint: composite of death, myocardial infarction, or urgent revascularization Primary safety endpoint: major hemorrhage

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Trial participants

3910 patients with unstable angina or non-Q-wave myocardial infarction of any age who suffered an acute myocardial infarction within the preceding 14 days

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Results

Efficacy outcome: By 48 hours, in 108 of 1953 patients (5.5%) and in 142 of 1957 patients (7.3%) receiving UFH, a primary event had occurred. At 8 days, the incidence of the primary end point was 12.4% in the enoxaparin group and 14.5% in the UFH group. At 14 days, the incidence was 14.2% vs. 16.7%, and by 43 days 17.3% vs. 19.7%
Safety outcome: During the first 72 hours major hemorrhage occurred in 16 of 1938 patients given enoxaparin (0.8%) and in 14 of 1936 patients given UFH (0.7%), as well as during the entire hospitalization phase in 29 patients (1.5%) given enoxaparin and 19 patients (1.0%) given UFH. Minor hemorrhage occurred in 99 (5.1%) vs. 45 (2.3%) of the enoxaparin vs. the UFH patients during the first 72 hours and in 176 (9.1%) vs. 48 (2.5%) patients during the entire hospitalization phase. During the outpatient phase, 34 of 1179 patients in the enoxaparin group (2.9%) and 18 of 1185 patients in the placebo group (1.5%) suffered a major hemorrhage, and 227 (19.3%) vs. 62 (5.2%) a minor hemorrhage

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Summary

Efficacy: Enoxaparin is superior to UFH in reducing the composite endpoint of death, myocardial infarction, and urgent revascularization during the acute management of unstable angina or non-Q-wave-infarction. In the outpatient phase the curves for the primary event rate remained parallel to each other, which suggests that there was no further relative treatment benefit of an additional 35 days of enoxaparin therapy
Safety: During the first 72 hours and throughout the initial hospitalization, there was no significant difference in the rate of major hemorrhage in the 2 treatment groups. There was a significantly higher rate of major hemorrhage during the outpatient phase in the enoxaparin group. At all time points, the rate of minor hemorrhage was significantly higher in the enoxaparin group

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Reference

Antman EM, McCabe CH, Gurfinkel EP, Turpie AGG, Bernink PJL, Salein D, Bayes de Luna A, Fox K, Lablanche J-M, Radley D, Premmereur J, Braunwald E, for the TIMI 11B Investigators. Enoxaparin prevents death and cardiac ischemic events in unstable angina/non-Q-wave myocardial infarction – Results of the Thrombolysis In Myocardial Infarction (TIMI) 11B. Circulation 1999;100:1593-1601

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Corresponding author

Elliott M. Antman, MD, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115
e-mail: eantman@rics.bwh.harvard.edu

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