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Table 3 Occurrence of primary efficacy endpoint overall and by protocol-defined subgroup – treated set

From: Dabigatran etexilate for thromboprophylaxis in over 5000 hip or knee replacement patients in a real-world clinical setting

 

THR

TKR

Total

Risk factor subgroups

N

n

Incidence %

95 % CI

N

n

Incidence %

95 % CI

N

n

Incidence %

95 % CI

All treated

2734

15

0.55

0.31, 0.90

2558

40

1.56

1.12, 2.12

5292

55

1.04

0.78, 1.35

Active smoker

 No

2269

13

0.57

0.31, 0.98

2319

35

1.51

1.05, 2.09

4588

48

1.05

0.77, 1.38

 Yes

465

2

0.43

0.05, 1.54

239

5

2.09

0.68, 4.81

704

7

0.99

0.40, 2.04

CAD

 No

2602

13

0.50

0.27, 0.85

2371

38

1.60

1.14, 2.19

4973

51

1.03

0.76, 1.35

 Yes

132

2

1.52

0.18, 5.37

187

2

1.07

0.13, 3.81

319

4

1.25

0.34, 3.18

CHF

 No

2680

15

0.56

0.31, 0.92

2485

40

1.61

1.15, 2.19

5165

55

1.06

0.80, 1.38

 Yes

54

0

0

0.00, 6.60

73

0

0

0.00, 4.93

127

0

0

0.00, 2.86

History of VTE

 No

2661

15

0.56

0.32, 0.93

2445

31

1.27

0.86, 1.79

5106

46

0.90

0.66, 1.20

 Yes

73

0

0

0.00, 4.93

113

9

7.96

3.71, 14.58

186

9

4.84

2.24, 8.99

Concomitant ASA

 No

2568

12

0.47

0.24, 0.81

2306

39

1.69

1.21, 2.30

4874

51

1.05

0.78, 1.37

 Yes

166

3

1.81

0.37, 5.19

252

1

0.40

0.01, 2.19

418

4

0.96

0.26, 2.43

Chronic use of NSAIDs

 No

2319

13

0.56

0.30, 0.96

2164

33

1.52

1.05, 2.13

4483

46

1.03

0.75, 1.37

 Yes

415

2

0.48

0.06, 1.73

394

7

1.78

0.72, 3.63

809

9

1.11

0.51, 2.10

  1. N number of patients, n number of patients with symptomatic VTE or who died of any cause
  2. ASA acetylsalicylic acid, CAD coronary heart disease, CHF chronic heart failure, CI confidence interval, NSAIDs non-steroidal anti-inflammatory drugs, THR total hip replacement, TKR total knee replacement, VTE venous thromboembolism