http://www.theheart.org/web_slides/1136801.do
A randomized, placebo study using patients with STEMI exposed to fondaparinux or to usual care-placebo. The Sixth Organization to Assess Strategies in Acute Ischemic Syndromes.
2. OASIS-6 (Sixth Organization to Assess Strategies in
Acute Ischemic Syndromes)
S Yusuf (McMaster University, Hamilton, ON)
American College of Cardiology 2006 Scientific Sessions
• Background:
There is a need for an effective, inexpensive, and safe antithrombotic
agent for patients with STEMI
• Population and treatment:
12 092 patients with STEMI were randomized to fondaparinux (2.5 mg
once daily given for up to eight days) or usual care—placebo for those in
whom UFH was not indicated (stratum 1) or UFH for up to 48 hours
followed by placebo for up to eight days (stratum 2)
• Primary outcome:
A composite of death or reinfarction at 30 days
UFH=unfractionated heparin
3. OASIS-6: Results
• Fondaparinux significantly reduced the primary efficacy end point
• There was no heterogeneity of the effects of fondaparinux in the two strata by
planned heparin use
• There was no benefit in the 3789 patients who underwent primary PCI
Primary end point
Time point Fondaparinux Control HR (95% CI) p
(n=6036), % (n=6056), %
30 days (primary end point) 9.7 11.2 0.86 (0.77–0.96) 0.008
9 days 7.4 8.9 0.83 (0.73–0.94) 0.003
3–6 months 13.4 14.8 0.88 (0.79–0.97) 0.008
4. OASIS-6: Commentary*
"I might . . . use fondaparinux for patients who are not going to get a PCI. It does
seem to have a bleeding advantage, but I will reserve judgment until I see a better
cut of the data."
- Dr Paul Armstrong
"In the absence of any further specific information from OASIS-6 about exactly who
did or did not receive any attempt at reperfusion (primary PCI, fibrinolytic), how it
was supported (placebo, unfractionated heparin, or fondaparinux), and exactly how
long patients were followed—it is hard to incorporate the information on
fondaparinux in the enlarging array of treatment options for managing STEMI
patients."
- Dr Elliott Antman
*All comments from Experts clash over relative benefits of enoxaparin and fondaparinux in EXTRACT-TIMI 25 and
OASIS-6 (http://www.theheart.org/article/674653.do)
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