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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
Kenneth W. Mahaffey, MD;
Marc Cohen, MD;
Jyotsna Garg, MS;
Elliott Antman, MD;
Neal S. Kleiman, MD;
Shaun G. Goodman, MD;
Lisa G. Berdan, PA-C;
Craig J. Reist, PhD;
Anatoly Langer, MD;
Harvey D. White, MD;
Philip E. Aylward, MD;
Jacques J. Col, MD;
James J. Ferguson III, MD;
Robert M. Califf, MD; for the SYNERGY Trial Investigators
JAMA. 2005;294:2594-2600.
Context The SYNERGY trial comparing enoxaparin and unfractionated heparin in high-risk patients with acute coronary syndromes (ACS) showed that enoxaparin was not inferior to unfractionated heparin in reducing death or nonfatal myocardial infarction (MI) at 30 days.
Objective To evaluate continued risk in this patient cohort through 6-month and 1-year follow-up.
Design, Setting, and Patients Overall, 9978 patients were randomized from August 2001 through December 2003 in 487 hospitals in 12 countries. Patients were followed up for 6 months and for 1 year.
Main Outcome Measures Six-month outcomes were death, nonfatal MI, revascularization procedures, stroke, and site-investigator–reported need for rehospitalization; 1-year outcome was all-cause death.
Results Six-month and 1-year follow-up data were available for 9957 (99.8%) and 9608 (96.3%) of 9978 patients, respectively; 541 patients (5.4%) had died at 6 months and 739 (7.4%) at 1 year. Death or nonfatal MI at 6 months occurred in 872 patients receiving enoxaparin (17.6%) vs 884 receiving unfractionated heparin (17.8%) (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.89-1.07; P = .65). In the subgroup of patients receiving consistent therapy, ie, only enoxaparin or unfractionated heparin during the index hospitalization (n = 6138), a reduction in death or nonfatal MI with enoxaparin was maintained at 180 days (HR, 0.85; 95% CI, 0.75-0.95; P = .006). Rehospitalization within 180 days occurred in 858 patients receiving enoxaparin (17.9%) and 911 receiving unfractionated heparin (19.0%) (HR, 0.94; 95% CI, 0.85-1.03; P = .17). One-year all-cause death rates were similar in the 2 treatment groups (380/4974 [7.6%] for enoxaparin vs 359/4948 [7.3%] for unfractionated heparin; HR, 1.06; 95% CI, 0.92-1.22; P = .44). One-year death rates in patients receiving consistent therapy were also similar (251/3386 [7.4%] for enoxaparin vs 213/2720 [7.8%] for unfractionated heparin; HR, 0.95; 95% CI, 0.79-1.14; P = .55).
Conclusions In the SYNERGY trial, patients continued to experience adverse cardiac events through long-term follow-up. The effect of enoxaparin on death or MI compared with that of unfractionated heparin at 6 months was similar to that observed at 30 days in the overall trial and in the consistent-therapy group. One-year death rates were also similar in both groups. High-risk patients with ACS remain susceptible to continued cardiac events despite aggressive therapies.
ClinicalTrials.gov Identifier: NCT00043784.
Author Affiliations: Duke Clinical Research Institute, Durham, NC (Drs Mahaffey, Reist, and Califf and Mss Garg and Berdan); Heart Hospital of New Jersey, Newark Beth Israel Medical Center, Newark (Dr Cohen); Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Boston, Mass (Dr Antman); Baylor College of Medicine, Houston, Tex (Dr Kleiman); Canadian Heart Research Centre, Division of Cardiology, St Michael’s Hospital, University of Toronto, Toronto, Ontario (Drs Goodman and Langer); Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (Dr White); Flinders Medical Centre, Bedford Park, South Australia (Dr Aylward); Clinique Universitaire St Luc, Brussels, Belgium (Dr Col); and Texas Heart Institute, Houston (Dr Ferguson).
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