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Content for site developed under the guidance of the TRACK Advisory Council.
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| | Interview with Kenneth W. Mahaffey, MD |
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| | | The SYNERGY Trial: Results and Clinical Implications
Heparins, including unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH), are a cornerstone of treatment for acute coronary syndromes (ACS). Nevertheless, our understanding of the optimal use of heparins is constantly evolving as treatment approaches are refined and tailored to the individual patient. Currently, the American College of Cardiology and American Heart Association consider the use of the LMWH enoxaparin as preferable to UFH as an anticoagulant for patients with unstable angina or non–ST-segment elevation myocardial infarction (UA/NSTEMI), unless coronary artery bypass grafting is planned within 24 hours.1 This was because the efficacy and safety of enoxaparin in high-risk patients who were treated with an early invasive strategy were not known. In order to answer this question, the SYNERGY trial was initiated, which compared the efficacy and safety of enoxaparin with that of UFH in over 10,000 high-risk patients with UA/NSTEMI.2
The primary results of SYNERGY were reported in the July 7, 2004 issue of JAMA and showed that enoxaparin was not superior to UFH but met the prespecified criteria for noninferiority. There was a modest increase in the risk of major bleeding with enoxaparin. The SYNERGY investigators concluded that enoxaparin is a safe and effective alternative to UFH in the treatment of high-risk patients with non–ST-segment elevation ACS. They noted that the advantage of convenience gained with enoxaparin should be balanced against the modest excess in major bleeding.
How will the results of SYNERGY affect the way patients with UA/NSTEMI are managed? The following program expert commentary by Kenneth Mahaffey, MD, of the Duke Clinical Research Institute at Duke University in Durham, North Carolina, provides an overview of the key findings of SYNERGY and insight into their potential impact on current clinical practice.
Dr Mahaffey is the corresponding author on the full journal publication. Robert Califf, MD, of Duke Clinical Research Institute at Duke University in Durham, North Carolina, and James Ferguson, MD, of Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston, Texas, were the principal investigators.
References
- Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE III, Steward DE, Théroux P. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non–ST-segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). 2002. Available at: http://www.acc.org/clinical/guidelines/unstable/unstable.pdf
- SYNERGY Trial Investigators. Enoxaparin vs unfractionated heparin in high-risk patients with non–ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA 2004;292:45–54.
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