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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.
Am Heart J. 2006 Dec; 152(6):1042-50.AH

Abstract

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.

Authors+Show Affiliations

Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. harveyw@adhb.govt.nzNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17161049

Citation

White, Harvey D., 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." American Heart Journal, vol. 152, no. 6, 2006, pp. 1042-50.
White HD, Kleiman NS, Mahaffey KW, 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. 2006;152(6):1042-50.
White, H. D., Kleiman, N. S., Mahaffey, K. W., Lokhnygina, Y., Pieper, K. S., Chiswell, K., Cohen, M., Harrington, R. A., Chew, D. P., Petersen, J. L., Berdan, L. G., Aylward, P. E., Nessel, C. C., Ferguson, J. J., & Califf, R. M. (2006). 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. American Heart Journal, 152(6), 1042-50.
White HD, 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. 2006;152(6):1042-50. PubMed PMID: 17161049.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - White,Harvey D, AU - Kleiman,Neal S, AU - Mahaffey,Kenneth W, AU - Lokhnygina,Yuliya, AU - Pieper,Karen S, AU - Chiswell,Karen, AU - Cohen,Marc, AU - Harrington,Robert A, AU - Chew,Derek P, AU - Petersen,John L, AU - Berdan,Lisa G, AU - Aylward,Philip E G, AU - Nessel,Christopher C, AU - Ferguson,James J,3rd AU - Califf,Robert M, PY - 2006/04/11/received PY - 2006/08/02/accepted PY - 2006/12/13/pubmed PY - 2007/1/9/medline PY - 2006/12/13/entrez SP - 1042 EP - 50 JF - American heart journal JO - Am Heart J VL - 152 IS - 6 N2 - 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. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/17161049/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(06)00718-6 DB - PRIME DP - Unbound Medicine ER -