PMID- 17964037
OWN - NLM
STAT- MEDLINE
DCOM- 20071120
LR  - 20220310
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 50
IP  - 18
DP  - 2007 Oct 30
TI  - Efficacy and safety of fondaparinux versus enoxaparin in patients with acute 
      coronary syndromes undergoing percutaneous coronary intervention: results from 
      the OASIS-5 trial.
PG  - 1742-51
AB  - OBJECTIVES: This study reports a prospectively planned analysis of patients with 
      acute coronary syndrome who underwent early percutaneous coronary intervention 
      (PCI) in the OASIS-5 (Fifth Organization to Assess Strategies in Ischemic 
      Syndromes) trial. BACKGROUND: In the OASIS-5 trial, fondaparinux was similar to 
      enoxaparin for short-term efficacy, but reduced major bleeding by one-half and 
      30-day mortality by 17%. METHODS: The OASIS-5 trial was a double-blind, 
      randomized comparison of fondaparinux and enoxaparin in 20,078 patients with 
      acute coronary syndrome. A total of 12,715 patients underwent heart 
      catheterization during the initial hospitalization, and 6,238 patients underwent 
      PCI. In the fondaparinux group, intravenous fondaparinux was given for PCI. In 
      the enoxaparin group, no additional anticoagulant was given if PCI was <6 h from 
      last subcutaneous dose, and additional intravenous unfractionated heparin (UFH) 
      was given if PCI was >6 h. RESULTS: Fondaparinux compared with enoxaparin reduced 
      major bleeding by more than one-half (2.4% vs. 5.1%, hazard ratio [HR] 0.46, p < 
      0.00001) at day 9, with similar rates of ischemic events, resulting in superior 
      net clinical benefit (death, myocardial infarction, stroke, major bleeding: 8.2% 
      vs. 10.4%, HR 0.78, p = 0.004). Fondaparinux reduced major bleeding 48 h after 
      PCI irrespective of whether PCI was performed <6 h of the last enoxaparin dose 
      (1.6% vs. 3.8%, HR 0.42, p < 0.0001) or >6 h when UFH was given (1.3% vs. 3.4%, 
      HR 0.39, p < 0.0001). Catheter thrombus was more common in patients receiving 
      fondaparinux (0.9%) than enoxaparin alone (0.4%), but was largely prevented by 
      using UFH at the time of PCI, without any increase in bleeding. CONCLUSIONS: 
      Upstream therapy with fondaparinux compared with upstream enoxaparin 
      substantially reduces major bleeding while maintaining efficacy, resulting in 
      superior net clinical benefit. The use of standard UFH in place of fondaparinux 
      at the time of PCI seems to prevent angiographic complications, including 
      catheter thrombus, without compromising the benefits of upstream fondaparinux.
FAU - Mehta, Shamir R
AU  - Mehta SR
AD  - Department of Medicine, McMaster University and Population Health Research 
      Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. 
      smehta@mcmaster.ca
FAU - Granger, Christopher B
AU  - Granger CB
FAU - Eikelboom, John W
AU  - Eikelboom JW
FAU - Bassand, Jean-Pierre
AU  - Bassand JP
FAU - Wallentin, Lars
AU  - Wallentin L
FAU - Faxon, David P
AU  - Faxon DP
FAU - Peters, Ron J G
AU  - Peters RJ
FAU - Budaj, Andrzej
AU  - Budaj A
FAU - Afzal, Rizwan
AU  - Afzal R
FAU - Chrolavicius, Susan
AU  - Chrolavicius S
FAU - Fox, Keith A A
AU  - Fox KA
FAU - Yusuf, Salim
AU  - Yusuf S
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20071015
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
RN  - 0 (Anticoagulants)
RN  - 0 (Enoxaparin)
RN  - 0 (Polysaccharides)
RN  - 9005-49-6 (Heparin)
RN  - J177FOW5JL (Fondaparinux)
SB  - IM
CIN - Nat Clin Pract Cardiovasc Med. 2008 Apr;5(4):184-5. PMID: 18283303
MH  - Angina, Unstable/*therapy
MH  - *Angioplasty, Balloon, Coronary
MH  - Anticoagulants/*therapeutic use
MH  - Cohort Studies
MH  - Double-Blind Method
MH  - Enoxaparin/*therapeutic use
MH  - Female
MH  - Fondaparinux
MH  - Heparin/administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/*therapy
MH  - Polysaccharides/*therapeutic use
MH  - Syndrome
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2007/10/30 09:00
MHDA- 2007/12/06 09:00
CRDT- 2007/10/30 09:00
PHST- 2007/05/21 00:00 [received]
PHST- 2007/07/30 00:00 [revised]
PHST- 2007/07/31 00:00 [accepted]
PHST- 2007/10/30 09:00 [pubmed]
PHST- 2007/12/06 09:00 [medline]
PHST- 2007/10/30 09:00 [entrez]
AID - S0735-1097(07)02494-1 [pii]
AID - 10.1016/j.jacc.2007.07.042 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2007 Oct 30;50(18):1742-51. doi: 10.1016/j.jacc.2007.07.042. 
      Epub 2007 Oct 15.