PMID- 17010793
OWN - NLM
STAT- MEDLINE
DCOM- 20061012
LR  - 20220316
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 48
IP  - 7
DP  - 2006 Oct 3
TI  - 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.
PG  - 1346-54
AB  - OBJECTIVES: The purpose of this study was to compare the effect of receiving 
      pretreatment with antithrombin before randomization as well as overall efficacy 
      and safety of enoxaparin versus unfractionated heparin (UFH) in the SYNERGY 
      (Superior Yield of the New Strategy of Enoxaparin, Revascularization, and 
      Glycoprotein IIb/IIIa Inhibitors) trial. BACKGROUND: The SYNERGY trial results 
      demonstrated noninferiority in outcomes with enoxaparin compared with UFH. 
      Randomized treatment was independent of prerandomization treatment. METHODS: 
      Analyses were first performed on the 4 prerandomization subgroups: patients who 
      received no antithrombin therapy and those who were treated with enoxaparin or 
      UFH or both. Then, we focused on the subgroup of patients who received no 
      pretreatment or were pretreated with and randomized to the same drug. Of the 
      9,978 patients, 2,440 did not receive prerandomization therapy and 6,138 received 
      consistent therapy through randomization. The primary end point was the composite 
      of death and nonfatal myocardial infarction (MI) at 30 days. RESULTS: After 
      adjustment for differences among the subgroups, no significant difference in the 
      association between the 4 pretreatment groups and death or MI remained (p = 
      0.171). The randomized treatment effect on 30-day death or MI tended to vary with 
      pretreatment (p = 0.055 for interaction test after adjustment). Patients who 
      received consistent therapy with enoxaparin had significantly less death or MI 
      than patients randomized to UFH (adjusted p = 0.041) with a trend toward 
      increased bleeding. CONCLUSIONS: Treatment with antithrombin therapy before 
      randomization had potential impact on comparison of study drug effects. After 
      adjustment for differences in baseline characteristics between subgroups, 
      consistent therapy with enoxaparin might be superior to UFH in reducing death or 
      nonfatal MI, with a modest excess in bleeding.
FAU - Cohen, Marc
AU  - Cohen M
AD  - HEART Hospital of New Jersey, Newark Beth Israel Medical Center, Newark, New 
      Jersey 07112, USA. marcohen@SBHCS.com
FAU - Mahaffey, Kenneth W
AU  - Mahaffey KW
FAU - Pieper, Karen
AU  - Pieper K
FAU - Pollack, Charles V Jr
AU  - Pollack CV Jr
FAU - Antman, Elliott M
AU  - Antman EM
FAU - Hoekstra, James
AU  - Hoekstra J
FAU - Goodman, Shaun G
AU  - Goodman SG
FAU - Langer, Anatoly
AU  - Langer A
FAU - Col, Jacques J
AU  - Col JJ
FAU - White, Harvey D
AU  - White HD
FAU - Califf, Robert M
AU  - Califf RM
FAU - Ferguson, James J
AU  - Ferguson JJ
CN  - SYNERGY Trial Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20060912
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
RN  - 0 (Enoxaparin)
RN  - 0 (Fibrinolytic Agents)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Aged
MH  - Coronary Artery Disease/*complications/surgery
MH  - Enoxaparin/*therapeutic use
MH  - Female
MH  - Fibrinolytic Agents/*therapeutic use
MH  - Heparin/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/mortality/*prevention & control
MH  - Myocardial Revascularization
MH  - Treatment Outcome
EDAT- 2006/10/03 09:00
MHDA- 2006/10/13 09:00
CRDT- 2006/10/03 09:00
PHST- 2005/09/01 00:00 [received]
PHST- 2006/05/05 00:00 [revised]
PHST- 2006/05/16 00:00 [accepted]
PHST- 2006/10/03 09:00 [pubmed]
PHST- 2006/10/13 09:00 [medline]
PHST- 2006/10/03 09:00 [entrez]
AID - S0735-1097(06)01799-2 [pii]
AID - 10.1016/j.jacc.2006.05.058 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2006 Oct 3;48(7):1346-54. doi: 10.1016/j.jacc.2006.05.058. 
      Epub 2006 Sep 12.