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OASIS-5 (Fifth Organization to Assess
Strategies in Acute Ischemic Syndromes)
OASIS-5 (Fifth Organization to Assess Strategies in Acute
Ischemic Syndromes)
S Yusuf (McMaster University, Hamilton, ON)
European Society of Cardiology 2005 Congress


• Background:
    Fondaparinux is the first of a new class of antithrombotic drugs: selective
    factor-Xa inhibitors
• Population and treatment:
    20 078 patients randomized within 24 hours of an ACS to fondaparinux
    (2.5 mg subcutaneously once daily) or enoxaparin (1 mg/kg twice daily) for
    two to eight days
• Primary outcomes:
    Primary efficacy outcome: a composite of death/MI/refractory ischemia at
    day 9
    Primary safety outcome: rate of major bleeding at day 9
OASIS-5: Results (efficacy)

• Fondaparinux is as effective as enoxaparin in the reduction of the primary
  efficacy end point: HR 1.01 (95% CI 0.90–1.13)

Efficacy results at day 9
End point                      Enoxaparin      Fondaparinux
                               (n=10 021), %   (n=10 057), %

Death/MI/refractory ischemia   5.8             5.9

Death/MI                       4.1             4.1

Death                          1.9             1.8

MI                             2.7             2.7

Refractory ischemia            1.9             2.05
OASIS-5: Results (safety)

• 47% reduction in major bleeds at day 9 with fondaparinux
• Net clinical benefit—combination of efficacy and bleeding results—at day 9 with
 fondaparinux (HR 0.82 , 95% CI 0.74–0.90; p<0.00001)

Bleeding results at day 9
End point           Enoxaparin      Fondaparinux    HR (95% CI)        p
                    (n=10 021), %   (n=10 057), %

Total bleeds        7.0             3.2             0.44 (0.39–0.51)   <0.0001

Major bleeds        4.0             2.1             0.53 (0.45–0.62)   <0.0001

TIMI major bleeds   1.3             0.7             0.54 (0.41–0.73)   <0.0001

Minor bleeds        3.1             1.1             0.35 (0.28–0.43)   <0.0001
OASIS-5: Commentary*

"This new drug . . . has a net clinical benefit at no greater financial cost."

                                                                                              - Dr Salim Yusuf


"There is no doubt in my mind that this drug is preferable to enoxaparin. Physicians
will have to think twice or thrice before prescribing enoxaparin after seeing these
reductions in bleeding and mortality with fondaparinux."

                                                                                    - Dr Shamir Mehta (co–
                                                                                          lead investigator)

"This is a great situation that we have previously only dreamed about."

                                                                                             - Dr Robert Califf

 *All comments from OASIS-5/Michelangelo: Dramatically reduced bleeding favors fondaparinux over
 enoxaparin in ACS (http://www.theheart.org/article/554453.do)
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OASIS-5 trial - Summary & Results at ESC

  • 1. OASIS-5 (Fifth Organization to Assess Strategies in Acute Ischemic Syndromes)
  • 2. OASIS-5 (Fifth Organization to Assess Strategies in Acute Ischemic Syndromes) S Yusuf (McMaster University, Hamilton, ON) European Society of Cardiology 2005 Congress • Background: Fondaparinux is the first of a new class of antithrombotic drugs: selective factor-Xa inhibitors • Population and treatment: 20 078 patients randomized within 24 hours of an ACS to fondaparinux (2.5 mg subcutaneously once daily) or enoxaparin (1 mg/kg twice daily) for two to eight days • Primary outcomes: Primary efficacy outcome: a composite of death/MI/refractory ischemia at day 9 Primary safety outcome: rate of major bleeding at day 9
  • 3. OASIS-5: Results (efficacy) • Fondaparinux is as effective as enoxaparin in the reduction of the primary efficacy end point: HR 1.01 (95% CI 0.90–1.13) Efficacy results at day 9 End point Enoxaparin Fondaparinux (n=10 021), % (n=10 057), % Death/MI/refractory ischemia 5.8 5.9 Death/MI 4.1 4.1 Death 1.9 1.8 MI 2.7 2.7 Refractory ischemia 1.9 2.05
  • 4. OASIS-5: Results (safety) • 47% reduction in major bleeds at day 9 with fondaparinux • Net clinical benefit—combination of efficacy and bleeding results—at day 9 with fondaparinux (HR 0.82 , 95% CI 0.74–0.90; p<0.00001) Bleeding results at day 9 End point Enoxaparin Fondaparinux HR (95% CI) p (n=10 021), % (n=10 057), % Total bleeds 7.0 3.2 0.44 (0.39–0.51) <0.0001 Major bleeds 4.0 2.1 0.53 (0.45–0.62) <0.0001 TIMI major bleeds 1.3 0.7 0.54 (0.41–0.73) <0.0001 Minor bleeds 3.1 1.1 0.35 (0.28–0.43) <0.0001
  • 5. OASIS-5: Commentary* "This new drug . . . has a net clinical benefit at no greater financial cost." - Dr Salim Yusuf "There is no doubt in my mind that this drug is preferable to enoxaparin. Physicians will have to think twice or thrice before prescribing enoxaparin after seeing these reductions in bleeding and mortality with fondaparinux." - Dr Shamir Mehta (co– lead investigator) "This is a great situation that we have previously only dreamed about." - Dr Robert Califf *All comments from OASIS-5/Michelangelo: Dramatically reduced bleeding favors fondaparinux over enoxaparin in ACS (http://www.theheart.org/article/554453.do)
  • 6. Become a member of http://www.theheart.org Become a fan on Facebook: http://www.facebook.com/theheartorg Follow us on Twitter: http://www.twitter.com/theheartorg theheart.org is the leading online source of independent cardiology news. We are the top provider of news and opinions for over 100 000 physicians.