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A Subgroup Analysis of the Impact of Prerandomization Antithrombin Therapy on Outcomes in the SYNERGY Trial

Enoxaparin Versus Unfractionated Heparin in Non–ST-Segment Elevation Acute Coronary Syndromes

Marc Cohen, MD, FACC^_*,_*, Kenneth W. Mahaffey, MD, FACC, Karen Pieper, MS, Charles V. Pollack, Jr, MD, Elliott M. Antman, MD, FACC, James Hoekstra, MD^||, Shaun G. Goodman, MD, FACC^¶, Anatoly Langer, MD, FACC^¶, Jacques J. Col, MD^#, Harvey D. White, MD^_**, Robert M. Califf, MD, FACC, James J. Ferguson, MD, FACC on behalf of the SYNERGY Trial Investigators

^_* HEART Hospital of New Jersey, Newark Beth Israel Medical Center, Newark, New Jersey
Duke Clinical Research Institute, Durham, North Carolina
^|| Wake Forest University Health Sciences, Winston-Salem, North Carolina
Pennsylvania Hospital, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
Brigham and Women’s Hospital, Boston, Massachusetts
^¶ Canadian Heart Research Centre and Terrence Donnelly Heart Center, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
^# Clinique Universitaire St. Luc, Brussels, Belgium
^_** Green Lane Hospital, Auckland, New Zealand
Texas Heart Institute, St. Luke’s-Episcopal Hospital, Houston, Texas.

View larger version (11K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Flow chart of patient subgroups by pretreatment. Enox = enoxaparin; UFH = unfractionated heparin.

View larger version (8K): [in this window] [in a new window] [Download PPT slide]   Figure 2 Odds ratios of 30-day death or myocardial infarction for randomized (rand) enoxaparin (Enox) versus unfractionated heparin (UFH) within pretreatment (pretx) subgroups. Interaction of pretreatment with randomized treatment: p = 0.0498 unadjusted, p = 0.055 adjusted.

View larger version (9K): [in this window] [in a new window] [Download PPT slide]   Figure 3 Odds ratios of Thrombolysis In Myocardial Infarction bleed for randomized Enox versus UFH within pretreatment subgroups. Interaction of pretreatment with randomized treatment: p = 0.270 unadjusted, p = 0.331 adjusted. Abbreviations as in Figure 2.

View larger version (8K): [in this window] [in a new window] [Download PPT slide]   Figure 4 Odds ratios of Global Utilization of Strategies to Open Occluded Arteries (GUSTO) severe bleed for randomized Enox versus UFH within pretreatment subgroups. Interaction of pretreatment with randomized treatment: p = 0.267 unadjusted, p = 0.227 adjusted. Other abbreviations as in Figure 2.

View larger version (8K): [in this window] [in a new window] [Download PPT slide]   Figure 5 Odds ratios of 30-day death or myocardial infarction for enoxaparin versus unfractionated heparin at randomization within consistent therapy subgroup. Interaction of pretreatment with randomized treatment: p < 0.001 unadjusted, p = 0.018 adjusted.

View larger version (8K): [in this window] [in a new window] [Download PPT slide]   Figure 6 Odds ratios of Thrombolysis In Myocardial Infarction bleed for enoxaparin versus unfractionated heparin at randomization within consistent therapy subgroup. Interaction of pretreatment with randomized treatment: p = 0.989 unadjusted, p = 0.583 adjusted.

View larger version (8K): [in this window] [in a new window] [Download PPT slide]   Figure 7 Odds ratio for Global Utilization of Strategies to Open Occluded Arteries (GUSTO) severe bleed for enoxaparin versus unfractionated heparin at randomization within consistent therapy subgroup. Interaction of pretreatment with randomized treatment: p = 0.265 unadjusted, p = 0.114 adjusted.