Superior Yield of the New strategy of Enoxaparin, Revascularization and GlYocprotein IIb/IIIa inhibitors (2005)


Prophylaxis for ischemic events in high-risk patients with non-ST-elevation acute coronary syndromes

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To compare the long-term effects of enoxaparin and UFH in patients with high-risk non-ST-elevation acute coronary syndromes and to evaluate the continued risk in this cohort throughout 6-months and 1-year follow-up after completion of the overall trial

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Trial design

Randomized, open study with parallel groups
Active treatment: enoxaparin 1 mg/kg s.c. twice daily (n=4993)
Control treatment: UFH 60 IU/kg i.v. bolus (maximum 5000 IU) followed by an infusion of 12 IU/kg/h with a target aPTT of 1.5–2.0 times the institutional ULN or 50–70 seconds (n=4985)

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Efficacy endpoints at 6 months: composite of death or non-fatal myocardial infarction; need for rehospitalization, rate of revascularization procedures
Efficacy endpoint at 1 year: all-cause death

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Trial participants

9978 patients (mean age 68 years) with non-ST-elevation acute coronary syndromes at rest of at least 10 minutes duration within 24 hours of randomization and with two of the following high-risk features: age ≥60 years, ST-segment changes, abnormal cardiac markers. Of these patients followed up 30 days in the first part of the SYNERGY trial, 6-month and 1-year followup data were available for 9957 and 9608 patients, respectively

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Efficacy outcome at 6 months: The composite endpoint of death or myocardial infarction occurred in 872 of 4993 patients (17.6%) receiving enoxaparin and in 884 of 4985 patients (17.8%) receiving UFH. 282 (5.7%) patients in the enoxaparin group and 259 (5.2%) died within 180 days. Rehospitalization occurred in 858 patients assigned to enoxaparin (17.9%) and in 911 receiving UFH. Revascularization procedures were performed in 73.5% of patients given enoxaparin and in 72.2% given UFH. Stroke was infrequent during 6-month follow-up and occurred in only 148 (1.5%) of all patients, without difference between treatment groups (1.5% for enoxaparin vs. 1.6% for UFH)
Efficacy outcome at 1 year: One-year all-cause death rates were similar in the 2 treatment groups: 7.6% (380/4974) for enoxaparin vs. 7.3% (359/4948) for UFH

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The rates of overall mortality and composite of death and non-fatal myocardial infarction were similar between treatment groups, showing that enoxaparin was at least as effective as UFH. Despite aggressive coronary revascularization and high use of evidence-based therapies, patients remained at high risk for recurrent cardiovascular ischemic complications

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Mahaffey KW, Cohen M, Garg J, Antman E, Kleiman NS, Goodman SG, Berdan LG, Reist CJ, Langer A, White HD, Aylward PE, Col JJ, Ferguson JJ 3rd, Califf RM. High-risk patients with acute coronary syndromes treated with low-molecular-weight or unfractionated heparin: outcomes at 6 months and 1 year in the SYNERGY trial. J Am Med Ass 2005;294:2594-2600

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Corresponding author

Kenneth W. Mahaffey, MD, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, e-mail:

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