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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

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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)


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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%)


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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%)


Completeness of follow

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


Completeness of follow

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


Completeness of follow

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


Completeness of follow

Clinical Implications

THE OASIS 5 TRIAL CLEARLY DEMONSTRATES

THAT FONDAPARINUX IS THE PREFERRED

ANTICOAGULANT FOR TREATMENT OF ACS