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Table 2 Incidence of MBEs overall and in protocol-defined risk factor subgroups – 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

19

0.69

0.42, 1.08

2558

19

0.74

0.45, 1.16

5292

38

0.72

0.51, 0.98

Active smoker

 No

2269

16

0.71

0.40, 1.14

2319

19

0.82

0.49, 1.28

4588

35

0.76

0.53, 1.06

 Yes

465

3

0.65

0.13, 1.87

239

0

0

0.00, 1.53

704

3

0.43

0.09, 1.24

CAD

 No

2602

18

0.69

0.41, 1.09

2371

18

0.76

0.45, 1.20

4973

36

0.72

0.51, 1.00

 Yes

132

1

0.76

0.02, 4.15

187

1

0.53

0.01, 2.94

319

2

0.63

0.08, 2.25

CHF

 No

2680

19

0.71

0.43, 1.10

2485

17

0.68

0.40, 1.09

5165

36

0.70

0.49, 0.96

 Yes

54

0

0

0.00, 6.60

73

2

2.74

0.33, 9.55

127

2

1.57

0.19, 5.57

History of VTE

 No

2661

19

0.71

0.43, 1.11

2445

17

0.70

0.41, 1.11

5106

36

0.71

0.49, 0.97

 Yes

73

0

0

0.00, 4.93

113

2

1.77

0.22, 6.25

186

2

1.08

0.13, 3.83

Concomitant ASA

 No

2568

17

0.66

0.39, 1.06

2306

17

0.74

0.43, 1.18

4874

34

0.70

0.48, 0.97

 Yes

166

2

1.20

0.15, 4.28

252

2

0.79

0.10, 2.84

418

4

0.96

0.26, 2.43

Chronic use of NSAIDs

 No

2319

17

0.73

0.43, 1.17

2164

17

0.79

0.46, 1.25

4483

34

0.76

0.53, 1. 06

 Yes

415

2

0.48

0.06, 1.73

394

2

0.51

0.06, 1.82

809

4

0.49

0.13, 1.26

  1. N: number of patients; n: number of patients with major bleeding events (MBE)
  2. ASA acetylsalicylic acid, CAD coronary artery 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