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Completeness of Follow. -. up. (20,078 patients). Hospital Discharge rec’d. 100%. 30 day rec’d. 99.98%. Lost to Follow. -. -Up at 9d. 12 patients (< 0.1%). Coordinating Center:. Population Health Research Institute,. McMaster University. Hamilton, Canada. Baseline Characteristics.

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Completeness of Follow

-

up

(20,078 patients)

Hospital Discharge rec’d

100%

30 day rec’d

99.98%

Lost to Follow

-

-Up at 9d

12 patients (< 0.1%)

Coordinating Center:

Population Health Research Institute,

McMaster University

Hamilton, Canada


Baseline Characteristics

Outcome

Enox

(%)

Fonda (%)

No. Rand.

10021

10057

Troponin

or CKMB > ULN

70.5

70.3

ECG with ischemia

79.8

80.6

>

50.3

51.7

ST depression

1mm

T wave inversion (>3 mm)

25.1

24.6

Male

61.4

62.0

Suspected MI w/o ST elevation

54.9

54.4

Prior Heart Failure

13.8

13.9

Prior MI

25.7

25.7

Hypertension

67.1

67.4

Diabetic

25.0

25.6

Current or Former Smoker

54.6

54.1


Therapies

During Initial

Hospitalization

Enox

(%)

Fonda (%)

No. Rand.

10021

10057

ASA

97.5

97.5

GPIIb/IIIa

Inhib

17.6

18.6

During PCI

41.0

41.7

Clopididogrel/Ticlopidine

67.2

67.6

Beta

-

blockers

87.7

87.2

Calcium Channel Blockers

26.8

26.9

ACE Inhibitors/ARB

76.1

74.9

Statins

77.5

78.5

70% of patients recruited from centers with

cath

labs


Days of Study Treatment

Compliance and Duration

Enox

Fonda

% who received

99.4%

99.2%

> 1 dose of drug

Mean No. of days

of therapy (SD)

5.2 (2.3)

5.4 (2.4)


Primary Efficacy Outcome

Death/MI/RI at Day 9

Non

-

inferiority

Margin=1.185

1.01

1.13

0.90

P

-

Value for Non

-

Inferiority=0.007

0.8

1

1.2

Fonda Better

Enox

Better

Hazard Ratio


Efficacy Outcomes at Day 9

Non

-

inferiority

Margin=1.185

Enox

Fonda

Death/MI/RI

5.7%

5.8%

Death/MI

4.1%

4.1%

Death

1.9%

1.8%

MI

2.7%

2.6%

Refract

1.9%

1.9%

Isch

0.8

1

1.2

Fonda Better

Enox

Better

Hazard Ratio


Major Bleeding: 9 Days

Enoxaparin

0.04

HR 0.52

95% CI 0.44

-

0.61

0.03

P<0.001

Cumulative Hazard

0.02

Fondaparinux

0.01

0.0

0

1

2

3

4

5

6

7

8

9

Days


Categories of Major Bleeds

at 9 Days

Enox

Fonda

P

(No. Pts)

(No. Pts)

No. Rand.

10021

10057

Total Bleeding

412 (4.1%)

217 (2.2%)

<0.001

Intracranial

7

7

Surgery

req’d

to stop bleed

73

40

Retroperitoneal

36

9

¯

³

315

152

Hb

3

g/dL

³

282

164

Transfusion

2 units


No. of Patients

Receiving Transfusions

Enox

Fonda

No. (%)

No. (%)

No. Randomized

10021

10057

1 Unit

24 (0.2%)

14 (0.1%)

2 Units

183 (1.9%)

133 (1.3%)

3 Units

56 (0.6%)

57 (0.6%)

4+ Units

166 (1.7%)

134 (1.3%)

Any transfusion

433 (4.3%)

338 (3.4%)


Efficacy

-

Safety Balance

Death/MI/RI/

Maj

Bleed: Day 9

Enoxaparin

0.08

0.06

Fondaparinux

Cumulative Hazard

0.04

HR 0.81

HR 0.82

95% CI 0.73

-

0.89

95% CI 0.74

-

0.90

P<0.001

0.02

0.0

0

1

2

3

4

5

6

7

8

9

Days


Efficacy Outcomes at Day 30

Enox

Fonda

Death/MI/RI

8.6%

8.0%

P=0.07

Death/MI

6.8%

6.2%

Death

3.5%

2.9%

P=0.02

MI

4.1%

3.9%

RI

2.2%

2.2%

Strokes

P=0.002

Death/MI/Stroke

0.8

1

1.2


Mortality: Day 30

Enoxaparin

0.03

Fondaparinux

0.02

Cumulative Hazard

HR 0.83

HR 0.83

95% CI 0.71

-

0.97

95% CI 0.71

-

0.97

0.01

P=0.02

0.0

0

3

6

9

12

15

18

21

24

27

30

Days


Major Bleeding: Day 30

0.05

Enoxaparin

0.04

0.03

Cumulative Hazard

Fondaparinux

0.02

HR 0.62

HR 0.63

95% CI 0.54

-

0.72

95% CI 0.55

-

0.73

0.01

P<0.001

0.0

0

3

6

9

12

15

18

21

24

27

30

Days


Death/MI/RI/Major Bleeds:

Day 30

0.12

Enoxaparin

0.10

Fondaparinux

0.08

Cumulative Hazard

0.06

HR 0.82

HR 0.83

0.04

95% CI 0.75

-

0.89

95% CI 0.76

-

0.90

P<0.001

0.02

0.0

0

3

6

9

12

15

18

21

24

27

30

Days


Efficacy at 6 Months

Enox

Fonda

P value

0.06

Death/MI/RI

13.2%

12.3%

0.05

Death/MI

11.4%

10.5%

0.05

Death

6.5%

5.8%

MI

6.6%

6.3%

0.04

Strokes

1.7%

1.3%

0.007

Death/MI/Stroke

12.5%

11.1%

0.8

1

1.2


Death or MI: 6 Months

0.12

Enoxaparin

0.10

Fondaparinux

0.08

Cumulative Hazard

0.06

HR 0.92

HR 0.91

95% CI 0.84

-1.00

95% CI 0.84

-

0.04

P=0.05

0.02

0.0

0

20

40

60

80

100

120

140

160

180

Days


Mortality at 6 Months

Enoxaparin

0.06

Fondaparinux

0.04

Cumulative Hazard

HR 0.89

HR 0.89

95% CI 0.80

-

95% CI 0.79

-

1.00

0.02

P=0.05

0.0

0

20

40

60

80

100

120

140

160

180

Days


Major Bleeding: 6 Months

0.06

Enoxaparin

0.05

0.04

Fondaparinux

0.03

Cumulative Hazard

HR 0.72

HR 0.72

0.02

95% CI 0.64

-

0.82

-

0.82

P<0.001

0.01

0.0

0

20

40

60

80

100

120

140

160

180

Days


Death, MI, RI,

Maj

or

B

leeding

at 6 Months

Enoxaparin

0.15

Fondaparinux

0.10

Cumulative Hazard

HR 0.86

HR 0.87

95% CI 0.81

-

0.93

95% CI 0.81

-

0.93

0.05

P<0.001

0.0

0

20

40

60

80

100

120

140

160

180

Days


Patients Undergoing PCI within

Patients Undergoing PCI within

the First 8 Days of Randomization

the First 8 Days of Randomization

Enoxaparin

Fondaparinux

(n=3104)

(n=3135)

Concomitant antithrombotic drugs

No. of events (% of patients)

Unfractionated heparin

1724 (55.5%)

651 (20.8%)

GP Iib/IIIa inhibitor

1273 (41.0%)

1308 (41.7%)

Thienopyridines

2317 (74.6%)

2348 (74.9%)


Patients Undergoing PCI within

Patients Undergoing PCI within

the First 8 Days of Randomization

the First 8 Days of Randomization

Enoxaparin

Relative Risk

Fondaparinux

P

Value

(n=3135)

(n=3104)

(95% CI)

Complications involving

No. of events (% of patients)

the vascular access site

Any complication

251 (8.1%)

103 (3.3%)

0.41 (0.33

-

0.51)

<0.001

Pseudoaneurysm

49 (1.6%)

31 (1.0%)

0.63 (0.40

-

0.98)

Large hematoma

138 (4.4%)

50 (1.6%)

0.36 (0.26

-

0.49)

PCI

-

related coronary

complication

Any complication

268 (8.6%)

299 (9.5%)

1.11 (0.94

-

1.29)

0.21

Abrupt closure, new thrombus

161 (5.2%)

188 (6.0%)

1.16 (0.94

-

1.42)

with reduced flow, dissection,

or no reflow

Catheter

-

related thrombus not

3 (0.1%)

9 (0.3%)

2.99 (0.81

-

11.04)

0.08

resulting in clinical

complications

All catheter

-

related thrombi

8 (0.4%)

29 (0.9%)

3.59 (1.64

-

7.84)

0.001


Patients Undergoing PCI within

Patients Undergoing PCI within

the First 8 Days of Randomization

the First 8 Days of Randomization

Enoxaparin

Relative Risk

Fondaparinux

P

Value

(n=3135)

(n=3104)

(95% CI)

Clinical Events at 9 days

No. of events (% of patients)

Death

38 (1.2%)

37 (1.2%)

0.96 (0.62

-

1.51)

MI

154 (5.0%)

161 (5.1%)

1.04 (0.84

-

1.28)

Stroke

13 (0.4%)

13 (0.4%)

0.99 (0.46

-

2.13)

Major Bleeding

158 (5.1%)

72 (2.3%)

0.45 (0.34

-

0.59)

Death, MI or stroke

190 (6.1%)

198 (6.3%)

1.03 (0.87

-

1.25)

Death, MI, stroke or major

321 (10.3%)

255 (8.2%)

0.79 (0.67

-

0.92)

0.003

bleeding

Any procedural complication,

major bleeding, death, MI or

638 (20.6%)

521 (16.6%)

0.81 (0.73

-

0.90)

<0.001

stroke


Patients Undergoing PCI within

Patients Undergoing PCI within

the First 8 Days of Randomization

the First 8 Days of Randomization

Enoxaparin

Relative Risk

Fondaparinux

P

Value

(n=3135)

(n=3104)

(95% CI)

Clinical Events at 30 days

No. of events (% of patients)

Death

65 (2.1%)

62 (2.0%)

0.94 (0.67

-

1.33)

MI

169 (5.4%)

179 (5.7%)

1.05 (0.86

-

1.29)

Stroke

22 (0.7%)

18 (0.6%)

0.81 (0.44

-

1.51)

Major Bleeding

169 (5.4%)

87 (2.8%)

0.51 (0.40

-

0.66)

Death, MI or stroke

228 (7.3%)

231 (7.4%)

1.00 (0.84

-

1.20)

Death, MI, stroke or major

364 (11.7%)

297 (9.5%)

0.81 (0.70

-

0.93)

0.004

bleeding


Clinical Implications

THE OASIS 5 TRIAL CLEARLY DEMONSTRATES

THAT FONDAPARINUX IS THE PREFERRED

ANTICOAGULANT FOR TREATMENT OF ACS


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