PMID- 15781750
OWN - NLM
STAT- MEDLINE
DCOM- 20050919
LR  - 20181201
IS  - 1524-4539 (Electronic)
IS  - 0009-7322 (Linking)
VI  - 111
IP  - 11
DP  - 2005 Mar 22
TI  - Randomized, blinded trial comparing fondaparinux with unfractionated heparin in 
      patients undergoing contemporary percutaneous coronary intervention: Arixtra 
      Study in Percutaneous Coronary Intervention: a Randomized Evaluation (ASPIRE) 
      Pilot Trial.
PG  - 1390-7
AB  - BACKGROUND: Factor Xa plays a central role in the generation of thrombin, making 
      it a novel target for treatment of arterial thrombosis. Fondaparinux is a 
      synthetic factor Xa inhibitor that has been shown to be superior to standard 
      therapies for the prevention of venous thrombosis. We performed a randomized 
      trial to determine the safety and feasibility of fondaparinux in the percutaneous 
      coronary intervention (PCI) setting. METHODS AND RESULTS: A total of 350 patients 
      undergoing elective or urgent PCI were randomized in a blinded manner to receive 
      unfractionated heparin (UFH), 2.5 mg fondaparinux IV, or 5.0 mg fondaparinux IV. 
      Randomization was stratified for planned or no planned use of glycoprotein (GP) 
      IIb/IIIa antagonists. The primary safety outcome was total bleeding, which was a 
      combination of major and minor bleeding events. The incidence of total bleeding 
      was 7.7% in the UFH group and 6.4% in the combined fondaparinux groups (hazard 
      ratio, 0.81; 95% confidence interval, 0.35 to 1.84; P=0.61). Bleeding was less 
      common in the 2.5-mg fondaparinux group compared with the 5-mg fondaparinux group 
      (3.4% versus 9.6%, P=0.06). The composite efficacy outcome of all-cause 
      mortality, myocardial infarction, urgent revascularization, or need for a bailout 
      GPIIb/IIIa antagonist was 6.0% in the UFH group and 6.0% in the fondaparinux 
      group, with no significant difference in efficacy among the fondaparinux doses 
      compared with UFH. Coagulation marker analysis at 6 and 12 hours after PCI 
      demonstrated that fondaparinux was superior to UFH in inducing a sustained 
      reduction in markers of thrombin generation, as measured by prothrombin fragment 
      F1.2 (P=0.02). CONCLUSIONS: In this pilot study of patients undergoing 
      contemporary PCI, factor Xa inhibition with the synthetic anticoagulant 
      fondaparinux in doses of 2.5 and 5.0 mg was comparable to UFH for clinical safety 
      and efficacy outcomes. These data form the basis for further evaluation of 
      fondaparinux in arterial thrombosis.
FAU - Mehta, Shamir R
AU  - Mehta SR
AD  - McMaster University and the Population Health Research Institute, Hamilton Health 
      Sciences, General Division, 237 Barton St E, Hamilton, Ontario, Canada L6K 1B8. 
      smehta@mcmaster.ca
FAU - Steg, Philippe Gabriel
AU  - Steg PG
FAU - Granger, Christopher B
AU  - Granger CB
FAU - Bassand, Jean-Pierre
AU  - Bassand JP
FAU - Faxon, David P
AU  - Faxon DP
FAU - Weitz, Jeffrey I
AU  - Weitz JI
FAU - Afzal, Rizwan
AU  - Afzal R
FAU - Rush, Bonnie
AU  - Rush B
FAU - Peters, Ron J G
AU  - Peters RJ
FAU - Natarajan, Madhu K
AU  - Natarajan MK
FAU - Velianou, James L
AU  - Velianou JL
FAU - Goodhart, David M
AU  - Goodhart DM
FAU - Labinaz, Marino
AU  - Labinaz M
FAU - Tanguay, Jean-Francois
AU  - Tanguay JF
FAU - Fox, Keith A A
AU  - Fox KA
FAU - Yusuf, Salim
AU  - Yusuf S
CN  - ASPIRE Investigators
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Circulation
JT  - Circulation
JID - 0147763
RN  - 0 (Anticoagulants)
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Polysaccharides)
RN  - 9005-49-6 (Heparin)
RN  - J177FOW5JL (Fondaparinux)
SB  - IM
MH  - Aged
MH  - *Angioplasty, Balloon, Coronary
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Emergencies
MH  - Factor Xa Inhibitors
MH  - Feasibility Studies
MH  - Female
MH  - Fondaparinux
MH  - Hemorrhage/etiology
MH  - Heparin/adverse effects/*therapeutic use
MH  - Hospital Mortality
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/epidemiology
MH  - Myocardial Revascularization/statistics & numerical data
MH  - Pilot Projects
MH  - Polysaccharides/adverse effects/*therapeutic use
MH  - Single-Blind Method
MH  - Stents
MH  - Treatment Outcome
EDAT- 2005/03/23 09:00
MHDA- 2005/09/20 09:00
CRDT- 2005/03/23 09:00
PHST- 2005/03/23 09:00 [pubmed]
PHST- 2005/09/20 09:00 [medline]
PHST- 2005/03/23 09:00 [entrez]
AID - 111/11/1390 [pii]
AID - 10.1161/01.CIR.0000158485.70761.67 [doi]
PST - ppublish
SO  - Circulation. 2005 Mar 22;111(11):1390-7. doi: 10.1161/01.CIR.0000158485.70761.67.