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Efficacy and safety of enoxaparin compared with unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention in the Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial.

Publication ,  Journal Article
White, HD; Kleiman, NS; Mahaffey, KW; Lokhnygina, Y; Pieper, KS; Chiswell, K; Cohen, M; Harrington, RA; Chew, DP; Petersen, JL; Berdan, LG ...
Published in: Am Heart J
December 2006

BACKGROUND: Enoxaparin reduces ischemic events more effectively than unfractionated heparin (UFH) in patients treated conservatively for non-ST-segment elevation acute coronary syndrome. The SYNERGY trial compared these agents in high-risk patients undergoing early invasive treatment. Enoxaparin was noninferior to UFH for the 30-day primary end point of death/myocardial infarction (MI), but modestly increased bleeding. METHODS AND RESULTS: This article compares the outcomes of the 4687 SYNERGY patients (47%) undergoing percutaneous coronary intervention, who were randomized to receive enoxaparin or UFH. Antithrombotic therapy was administered prerandomization in 78%. Crossover (usually in the catheterization laboratory) to the alternative antithrombotic occurred in 14.6% of enoxaparin patients and 2.9% of UFH-treated patients (P < .0001). Stenting was performed in 86.3%. Abrupt vessel closure occurred in 1.3% of enoxaparin patients and 1.7% of UFH-treated patients (P = .318). The rates of death/MI were similar at 30 days (13.1% with enoxaparin vs 14.2% with UFH, P = .289). GUSTO severe bleeding occurred with similar frequency in both groups (1.5% vs 1.6%, P = .688). TIMI major bleeding was more common with enoxaparin (3.7% vs 2.5% with UFH, P = .028). Transfusions were more frequent with enoxaparin than with UFH (6.8% vs 5.4%, P = .047). TIMI major bleeding increased with crossover from enoxaparin to UFH (from 3.7% to 7.8%) and from UFH to enoxaparin (from 2.5% to 8.6%). Statistical adjustment to model reasons for crossover did not affect the overall safety and efficacy outcomes. CONCLUSIONS: In high-risk patients undergoing early percutaneous coronary intervention for acute coronary syndrome, enoxaparin avoids the need for monitoring and achieves similar effectiveness to UFH but is associated with more bleeding.

Duke Scholars

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2006

Volume

152

Issue

6

Start / End Page

1042 / 1050

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Syndrome
  • Risk Factors
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Middle Aged
  • Male
  • Humans
  • Heparin
  • Hemorrhage
  • Female
 

Citation

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Chicago
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MLA
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White, Harvey D., Neal S. Kleiman, Kenneth W. Mahaffey, Yuliya Lokhnygina, Karen S. Pieper, Karen Chiswell, Marc Cohen, et al. “Efficacy and safety of enoxaparin compared with unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention in the Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial.Am Heart J 152, no. 6 (December 2006): 1042–50. https://doi.org/10.1016/j.ahj.2006.08.002.
White HD, Kleiman NS, Mahaffey KW, Lokhnygina Y, Pieper KS, Chiswell K, Cohen M, Harrington RA, Chew DP, Petersen JL, Berdan LG, Aylward PEG, Nessel CC, Ferguson JJ, Califf RM. Efficacy and safety of enoxaparin compared with unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention in the Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial. Am Heart J. 2006 Dec;152(6):1042–1050.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2006

Volume

152

Issue

6

Start / End Page

1042 / 1050

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Syndrome
  • Risk Factors
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Middle Aged
  • Male
  • Humans
  • Heparin
  • Hemorrhage
  • Female