PMID- 12228784
OWN - NLM
STAT- MEDLINE
DCOM- 20020927
LR  - 20220318
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 144
IP  - 3
DP  - 2002 Sep
TI  - Randomized double-blind safety study of enoxaparin versus unfractionated heparin 
      in patients with non-ST-segment elevation acute coronary syndromes treated with 
      tirofiban and aspirin: the ACUTE II study. The Antithrombotic Combination Using 
      Tirofiban and Enoxaparin.
PG  - 470-7
AB  - BACKGROUND: In comparison with treatment with unfractionated heparin (UFH) and 
      aspirin (ASA), both tirofiban administered with UFH and ASA, and enoxaparin plus 
      ASA have shown superiority in reducing cardiac ischemic events in patients with 
      unstable angina and non-ST-segment elevation myocardial infarction. Replacing UFH 
      with enoxaparin when tirofiban is administered to patients may offer further 
      therapeutic benefit, but could also increase bleeding. OBJECTIVE: Our objective 
      was to provide estimates of the frequency of bleeding complications, as defined 
      by means of the Thrombolysis In Myocardial Infarction(TIMI) group, and collect 
      data on clinical efficacy of the combination of tirofiban with enoxaparin plus 
      ASA. METHODS: Five hundred twenty-five patients with UA/NSTEMI were treated with 
      tirofiban coadministered with ASA and randomized to receive either UFH (n = 210) 
      or enoxaparin (n = 315). Therapy was administered for 24 to 96 hours. Bleeding 
      incidences were assessed until 24 hours after trial therapy was discontinued; 
      other clinical outcomes were assessed for as long as 30 days. RESULTS: The total 
      bleeding rate (TIMI major + minor + loss-no-site) for the UFH group versus the 
      enoxaparin group was 4.8% vs 3.5% (odds ratio [OR] 1.4, CI 0.6-3.4). The TIMI 
      major and minor bleeding rates for the UFH versus the enoxaparin groups were 1.0% 
      versus 0.3% (OR 3.0, CI 0.3-33.8) and 4.3% versus 2.5% (OR 1.7, CI 0.7-4.6). 
      There was an increase in nuisance cutaneous and oral bleeds (<50 mL of blood 
      loss) in the enoxaparin group. Death or myocardial infarction occurred with 
      similar frequency in the 2 groups (9.0% vs 9.2%). However, refractory ischemia 
      requiring urgent revascularization and rehospitalization because of unstable 
      angina occurred more frequently in the UFH group (4.3% vs 0.6% and 7.1% vs 1.6%, 
      respectively). CONCLUSIONS: Combination therapy with tirofiban plus enoxaparin 
      appears safe, relative to therapy with tirofiban plus UFH.
FAU - Cohen, Marc
AU  - Cohen M
AD  - MCP Hahnemann University School of Medicine, Philadelphia, Pa, USA. 
      marc.cohen@tenethealth.com
FAU - Theroux, Pierre
AU  - Theroux P
FAU - Borzak, Steven
AU  - Borzak S
FAU - Frey, Martin J
AU  - Frey MJ
FAU - White, Harvey D
AU  - White HD
FAU - Van Mieghem, W
AU  - Van Mieghem W
FAU - Senatore, Fred
AU  - Senatore F
FAU - Lis, Joy
AU  - Lis J
FAU - Mukherjee, Robin
AU  - Mukherjee R
FAU - Harris, Kathy
AU  - Harris K
FAU - Bigonzi, Frederique
AU  - Bigonzi F
CN  - ACUTE II Investigators
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Enoxaparin)
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Platelet Glycoprotein GPIIb-IIIa Complex)
RN  - 42HK56048U (Tyrosine)
RN  - 9005-49-6 (Heparin)
RN  - GGX234SI5H (Tirofiban)
RN  - R16CO5Y76E (Aspirin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Aspirin/adverse effects/*therapeutic use
MH  - Coronary Disease/diagnosis/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Electrocardiography/*statistics & numerical data
MH  - Enoxaparin/*therapeutic use
MH  - Female
MH  - Fibrinolytic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Hemorrhage/*chemically induced
MH  - Heparin/adverse effects/*therapeutic use
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Platelet Glycoprotein GPIIb-IIIa Complex/adverse effects/*therapeutic use
MH  - Tirofiban
MH  - Treatment Outcome
MH  - Tyrosine/adverse effects/*analogs & derivatives/*therapeutic use
EDAT- 2002/09/14 10:00
MHDA- 2002/09/28 04:00
CRDT- 2002/09/14 10:00
PHST- 2002/09/14 10:00 [pubmed]
PHST- 2002/09/28 04:00 [medline]
PHST- 2002/09/14 10:00 [entrez]
AID - S0002870302001114 [pii]
AID - 10.1067/mhj.2002.126115 [doi]
PST - ppublish
SO  - Am Heart J. 2002 Sep;144(3):470-7. doi: 10.1067/mhj.2002.126115.