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Exploring the role of enoxaparin in the management of high-risk patients with non-ST-elevation acute coronary syndromes: the SYNERGY trial.
Am Heart J. 2005 Apr; 149(4 Suppl):S81-90.AH

Abstract

BACKGROUND

In patients with non-ST-elevation acute coronary syndromes (NSTE ACS), enoxaparin has been shown to be superior to unfractionated heparin (UFH) and is associated with a reduction in ischemic end points with nonsignificant increases in bleeding. However, the critical trials comparing enoxaparin with UFH were conducted before the widespread use of early invasive management and the availability of clopidogrel and glycoprotein IIb/IIIa receptor antagonists.

METHODS

SYNERGY was an international, multicenter, randomized, open-label trial that compared enoxaparin with UFH in high-risk NSTE ACS patients managed with an early invasive strategy. For enrollment, 2 out of 3 high-risk features were required: age > or =60 years, elevated cardiac biomarkers, or ST-segment changes. The primary efficacy end point was death/myocardial infarction (MI) at 30 days. The primary safety end point was inhospital major bleeding or stroke through 30 days.

RESULTS

The incidence of death/MI at 30 days was 14.0% in the enoxaparin group and 14.5% in the UFH group (hazard ratio 0.96, 95% CI 0.86-1.06), demonstrating noninferiority of enoxaparin relative to UFH. Enoxaparin was associated with a small but significant excess of Thrombolysis In Myocardial Infarction (TIMI) major bleeding, but there was no statistically significant increase in Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding or the rate of transfusion. There was no difference in complications of percutaneous coronary intervention. Interpretation of trial results was complicated by widespread use of enoxaparin or UFH before randomization, and by postrandomization crossover to the nonrandomized agent.

CONCLUSIONS

In patients with NSTE ACS, including high-risk patients proceeding rapidly to catheterization, enoxaparin is an effective and safe alternative to UFH.

Authors+Show Affiliations

Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.No affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16124952

Citation

Mahaffey, Kenneth W., and James J. Ferguson. "Exploring the Role of Enoxaparin in the Management of High-risk Patients With non-ST-elevation Acute Coronary Syndromes: the SYNERGY Trial." American Heart Journal, vol. 149, no. 4 Suppl, 2005, pp. S81-90.
Mahaffey KW, Ferguson JJ. Exploring the role of enoxaparin in the management of high-risk patients with non-ST-elevation acute coronary syndromes: the SYNERGY trial. Am Heart J. 2005;149(4 Suppl):S81-90.
Mahaffey, K. W., & Ferguson, J. J. (2005). Exploring the role of enoxaparin in the management of high-risk patients with non-ST-elevation acute coronary syndromes: the SYNERGY trial. American Heart Journal, 149(4 Suppl), S81-90.
Mahaffey KW, Ferguson JJ. Exploring the Role of Enoxaparin in the Management of High-risk Patients With non-ST-elevation Acute Coronary Syndromes: the SYNERGY Trial. Am Heart J. 2005;149(4 Suppl):S81-90. PubMed PMID: 16124952.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Exploring the role of enoxaparin in the management of high-risk patients with non-ST-elevation acute coronary syndromes: the SYNERGY trial. AU - Mahaffey,Kenneth W, AU - Ferguson,James J, PY - 2005/8/30/pubmed PY - 2005/9/16/medline PY - 2005/8/30/entrez SP - S81 EP - 90 JF - American heart journal JO - Am Heart J VL - 149 IS - 4 Suppl N2 - BACKGROUND: In patients with non-ST-elevation acute coronary syndromes (NSTE ACS), enoxaparin has been shown to be superior to unfractionated heparin (UFH) and is associated with a reduction in ischemic end points with nonsignificant increases in bleeding. However, the critical trials comparing enoxaparin with UFH were conducted before the widespread use of early invasive management and the availability of clopidogrel and glycoprotein IIb/IIIa receptor antagonists. METHODS: SYNERGY was an international, multicenter, randomized, open-label trial that compared enoxaparin with UFH in high-risk NSTE ACS patients managed with an early invasive strategy. For enrollment, 2 out of 3 high-risk features were required: age > or =60 years, elevated cardiac biomarkers, or ST-segment changes. The primary efficacy end point was death/myocardial infarction (MI) at 30 days. The primary safety end point was inhospital major bleeding or stroke through 30 days. RESULTS: The incidence of death/MI at 30 days was 14.0% in the enoxaparin group and 14.5% in the UFH group (hazard ratio 0.96, 95% CI 0.86-1.06), demonstrating noninferiority of enoxaparin relative to UFH. Enoxaparin was associated with a small but significant excess of Thrombolysis In Myocardial Infarction (TIMI) major bleeding, but there was no statistically significant increase in Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding or the rate of transfusion. There was no difference in complications of percutaneous coronary intervention. Interpretation of trial results was complicated by widespread use of enoxaparin or UFH before randomization, and by postrandomization crossover to the nonrandomized agent. CONCLUSIONS: In patients with NSTE ACS, including high-risk patients proceeding rapidly to catheterization, enoxaparin is an effective and safe alternative to UFH. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/16124952/Exploring_the_role_of_enoxaparin_in_the_management_of_high_risk_patients_with_non_ST_elevation_acute_coronary_syndromes:_the_SYNERGY_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(05)00202-4 DB - PRIME DP - Unbound Medicine ER -