SYNERGY

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

Condition

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

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Objective

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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Endpoints

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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Results

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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Summary

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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Reference

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: mahaf002@mc.duke.edu

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