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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 STEMI results of the OASIS 6 trial

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

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


Primary efficacy outcome death mi at 30 days1

Primary Efficacy OutcomeDeath/MI at 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


Efficacy of fondaparinux by strata on death mi at study end

Efficacy of Fondaparinux by Strataon Death/MI at Study End


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


Severe hemorrhage at 9 days

Severe Hemorrhage at 9 Days


Severe hemorrhage by type of reperfusion therapy at 180 days

Severe Hemorrhage by type of reperfusion therapy at 180 Days


Death and net clinical benefit at study end

Death and Net Clinical Benefit at Study End


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


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

Death and MI at 30 days

≥75 Yr

≥75 Yr

≥75 Yr

≥75 Yr


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

Death and MI at 30 days

≥ 75 Yr

≥75 Yr

≥75 Yr

≥75 Yr


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

Severe hemorrhage at 30 days


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

Net clinical benefit


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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