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Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From the OASIS 6 Trial Ron J.G. Peters, MD Cardiologist Department of Cardiology University of Amsterdam Amsterdam, Netherlands.

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Efficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation Myocardial Infarction: Data From the OASIS 6 TrialRon J.G. Peters, MDCardiologistDepartment of CardiologyUniversity of AmsterdamAmsterdam, Netherlands

efficacy and safety of fondaparinux in elderly patients with stemi results of the oasis 6 trial

Efficacy and safety of fondaparinux inelderly patients with STEMIresults of the OASIS 6 trial

RJ Peters, C Joyner, JP Bassand,

R Afzal, S Chrolavicius, JW Eikelboom, SR Mehta, Fox KAA, S Yusuf,

For the OASIS 6 investigators

disclosure
Disclosure

Funded by Organon, Sanofi-Aventis, GSK

All authors have received grants and honoraria

from these companies and from several others

fondaparinux mechanism of action
Fondaparinux:Mechanism of Action

Intrinsic

pathway

Extrinsic pathway

Antithrombin

Xa

Xa

AT

AT

AT

Fondaparinux

THROMBIN

II

IIa

Recycled

Fibrinogen

Fibrin clot

Turpie AGG et al. NEngl J Med. 2001;344:619.

oasis 6 randomized double blind double dummy
OASIS 6: Randomized, Double Blind, Double Dummy

12,000 Patients with STEMI < 12 h of symptom onset

Inclusion: ST   2 mm prec leads or  1 mm limb leads

Exclusion: Contra-ind. for anticoagulant, INR>1.8, pregnancy, ICH<12 mo.

Lytics (SK, TPA, TNK, RPA), Primary PCI or no reperfusion (eg. late)

Stratification

UFH not indicated

UFH indicated

Randomization

Randomization

Fondaparinux

2.5 mg

Placebo

Fondaparinux

2.5 mg

UFH

primary efficacy outcome death mi at 30 days
Primary Efficacy OutcomeDeath/MI at 30 Days

0.12

UFH/Placebo

0.10

Fondaparinux

0.08

0.06

Cumulative Hazard

HR 0.86

95% CI 0.77-0.96

P=0.008

0.04

0.02

0.0

0

3

6

9

12

15

18

21

24

27

30

Days

death at study end 3 or 6 months
Death at Study End (3 or 6 months)

0.12

UFH/Placebo

0.10

Fondaparinux

0.08

0.06

Cumulative Hazard

HR 0.88

95% CI 0.79-0.99

P=0.029

0.04

0.02

0.0

0

18

36

54

72

90

108

126

144

162

180

Days

pre specified subgroup analyses
Pre-Specified Subgroup Analyses

Death or MI at 30 days

Interaction P value

N

UFH/Placebo

Fonda

Overall

12092

11.2%

9.7%

Initial Reperfusion Rx

0.04

None

2867

15.1

12.2

Thrombolytic

5436

13.6

10.9

Primary PCI

3789

4.9

6.0

GRACE Risk Score

0.03

< 112

5958

4.3

4.6

>=112

6134

18.0

14.5

0.5

0.7

0.8

1.0

1.2

1.4

1.6

2.0

Fonda better

UFH/Plac better

Hazard Ratio

severe hemorrhage definition
Severe Hemorrhagedefinition
  • Fatal
  • Intracranial
  • Cardiac tamponade
  • Clinically significant hemorrhage with decrease Hb > 5 gm/dl with each unit of transfusion counting for 1 gm/dl Hb
elderly patients with stemi
Elderly patients with STEMI
  • Higher risk of adverse outcome
  • Higher risk of bleeding with thrombolytics
  • Higher risk of bleeding with anticoagulants
  • Net clinical outcome not predictable
elderly patients in oasis 6 methods
Elderly patients in OASIS 6methods
  • Post hoc analysis
  •  ≥75 years versus < 75 years
  • Primary endpoints as in main study
  • Net clinical benefit: death, MI, severe hemorrhage at 30 days
slide18

Death and MI at 30 days

≥75 Yr

≥75 Yr

≥75 Yr

≥75 Yr

slide19

Death and MI at 30 days

≥ 75 Yr

≥75 Yr

≥75 Yr

≥75 Yr

conclusions
conclusions

In patients with STEMI who are not treated with PPCI:

  • The efficacy and safety of fondaparinux as compared to control treatment are consistent across age groups
  • Consequently, the net clinical benefit of fondaparinux is consistent across age groups
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