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Table 4 Patient background of clinical events in the asymptomatic PE and asymptomatic DVT groups

From: Rivaroxaban treatment for asymptomatic venous thromboembolism: insights from the J’xactly study

 

Asymptomatic PE with/without DVT

Asymptomatic DVT

 

Total

Occurred clinical events

Not occurred clinical events

P-value

Total

Occurred clinical events

Not occurred clinical events

P-value

Clinically relevant events

n = 197

n = 25

n = 172

 

n = 203

n = 33

n = 170

 

Age (years)

65 ± 14

67 ± 14

65 ± 15

0.47

72 ± 12

74 ± 11

71 ± 12

0.28

 ≥ 75 years

58 (29.4%)

7 (28.0%)

51 (29.7%)

1.00

88 (43.3%)

17 (51.5%)

71 (41.8%)

0.34

Female

94 (47.7%)

11 (44.0%)

83 (48.3%)

0.83

151 (74.4%)

24 (72.7%)

127 (74.7%)

0.49

Body weight (kg)

62.7 ± 13.8

61.3 ± 13.5

62.9 ± 13.8

0.60

55.5 ± 11.6

51.0 ± 10.5

56.3 ± 11.8

0.017

 < 50 kg

33 (16.8%)

7 (28.0%)

26 (15.1%)

0.15

63 (31.0%)

15 (45.5%)

48 (28.2%)

0.06

CrCL (mL/minute)

84.5 ± 33.8

83.7 ± 37.3

84.7 ± 33.3

0.90

72.9 ± 28.4

67.8 ± 31.4

73.9 ± 27.7

0.26

 < 50 mL/minute

29 (14.7%)

4 (16.0%)

25 (14.5%)

0.77

47 (23.2%)

13 (39.4%)

34 (20.0%)

0.025

Diabetes mellitus

27 (13.7%)

1 (4.0%)

26 (15.1%)

0.21

28 (13.8%)

3 (9.1%)

25 (14.7%)

0.58

Chronic heart and lung disease

7 (3.6%)

3 (12.0%)

4 (2.3%)

0.045

9 (4.4%)

3 (9.1%)

6 (3.5%)

0.16

Active cancer

54 (27.4%)

14 (56.0%)

40 (23.3%)

0.001

55 (27.1%)

18 (54.5%)

37 (21.8%)

< 0.001

D-dimer (µg/mL)

9.3 (5.3–17.5)

9.5 (6.3–16.1)

9.1 (5.1–17.5)

0.65

6.6 (2.9–11.9)

7.1 (3.4–11.1)

6.4 (2.7–12.3)

0.40

Initial rivaroxaban treatment

Treatment duration, days

Median (IQR)

361 (165–630)

222 (107–319)

406 (173–647)

0.002

106 (68–259)

170 (100–388)

99 (55–223)

0.030

Recurrence or aggravation of symptomatic VTE

n = 197

n = 6

n = 191

 

n = 203

n = 6

n = 197

 

Age (years)

65 ± 14

60 ± 17

65 ± 14

0.35

70 ± 12

72 ± 10

70 ± 12

0.81

 ≥ 75 years

58 (29.4%)

1 (16.7%)

57 (29.8%)

0.67

134 (42.1%)

3 (37.5%)

131 (42.3%)

1.00

Female

94 (47.7%)

4 (66.7%)

90 (47.1%)

0.43

220 (69.2%)

6 (75.0%)

214 (69.0%)

1.00

Body weight (kg)

62.7 ± 13.7

70.0 ± 14.0

62.4 ± 13.7

0.18

57.3 ± 12.6

55.7 ± 13.5

57.3 ± 12.6

0.72

 < 50 kg

33 (16.8%)

1 (16.7%)

32 (16.8%)

1.00

90 (28.3%)

4 (50.0%)

86 (27.7%)

0.23

CrCL (mL/minute)

84.5 ± 33.8

114.4 ± 44.0

83.6 ± 33.1

0.027

72.9 ± 28.4

67.5 ± 33.3

73.1 ± 28.3

0.64

 < 50 mL/minute

29 (14.9%)

0 (0.0%)

29 (15.3%)

0.59

69 (22.0%)

3 (37.5%)

66 (21.6%)

0.38

Diabetes mellitus

27 (13.7%)

0 (0.0%)

27 (14.1%)

1.00

41 (12.9%)

1 (12.5%)

40 (12.9%)

1.00

Chronic heart and lung disease

7 (3.6%)

0 (0.0%)

7 (3.7%)

1.00

17 (5.4%)

1 (12.5%)

16 (5.2%)

0.36

Active cancer

51 (25.9%)

1 (16.7%)

50 (26.2%)

1.00

75 (23.6%)

2 (25.0%)

73 (23.6%)

1.00

D-dimer (µg/mL)

9.3 (5.3–17.5)

8.0 (5.1–9.3)

9.3 (5.2–17.5)

0.30

7.9 (3.5–14.2)

10.7 (3.1–16.5)

7.8 (3.5–14.2)

0.60

Initial rivaroxaban treatment

Treatment duration, days

Median (IQR)

361 (165–630)

216 (80–477)

362 (166–630)

0.37

106 (68–259)

170 (147–321)

173 (85–514)

0.82

Major bleeding

n = 197

n = 4

n = 193

 

n = 203

n = 6

n = 197

 

Age (years)

65 ± 14

55 ± 19

65 ± 14

0.16

70 ± 12

72 ± 10

70 ± 12

0.72

 ≥ 75 years

58 (29.4%)

0 (0.0%)

58 (30.1%)

0.32

134 (42.1%)

3 (37.5%)

131 (42.3%)

1.00

Female

94 (47.7%)

3 (75.0%)

91 (47.2%)

0.35

220 (69.2%)

5 (62.5%)

215 (69.4%)

0.71

Body weight (kg)

62.7 ± 13.8

54.9 ± 13.5

62.8 ± 13.8

0.26

57.3 ± 12.6

54.3 ± 8.5

57.4 ± 12.7

0.50

 < 50 kg

33 (16.8%)

2 (50.0%)

31 (16.1%)

0.13

90 (28.3%)

1 (12.5%)

89 (28.7%)

0.45

CrCL (mL/minute)

84.5 ± 33.8

111.9 ± 58.6

84.0 ± 33.1

0.10

72.9 ± 28.4

63.1 ± 18.7

73.2 ± 28.6

0.39

 < 50 mL/minute

29 (14.9%)

0 (0.0%)

29 (15.2%)

1.00

69 (22.0%)

2 (25.0%)

67 (21.9%)

0.69

Diabetes mellitus

27 (13.7%)

0 (0.0%)

27 (14.0%)

1.00

41 (12.9%)

1 (12.5%)

40 (12.9%)

1.00

Chronic heart and lung disease

7 (3.6%)

1 (25.0%)

6 (3.1%)

0.14

17 (5.4%)

0 (0.0%)

17 (5.5%)

1.00

Active cancer

54 (27.4%)

0 (0.0%)

54 (28.0%)

0.58

75 (23.6%)

4 (50.0%)

71 (22.9%)

0.09

D-dimer (µg/mL)

9.3 (5.3–17.5)

10.3 (9.5–15.4)

9.1 (5.2–17.5)

0.53

7.9 (3.5–14.2)

7.1 (2.7–23.7)

7.9 (3.6–14.2)

0.96

Initial rivaroxaban treatment

Treatment duration, days

Median (IQR)

361 (165–630)

236 (41–371)

362 (168–631)

0.18

106 (68–259)

294 (38–595)

173 (86–514)

0.92

  1. Data are shown as n (%), median (interquartile range), or mean ± standard deviation, unless otherwise stated
  2. Clinically relevant events were evaluated as a composite outcome, in which each component (recurrent VTE, acute coronary syndrome, ischemic stroke, death from any cause, and major bleeding events) was weighted equally. CI Confidence interval, CVD Cardiovascular disease, DVT Deep vein thrombosis, HR Hazard ratio, PE Pulmonary embolism, VTE Venous thromboembolism, Data are presented as n (%) or mean ± SD. CrCL Creatinine clearance, DVT Deep vein thrombosis, IQR Interquartile range, PE Pulmonary embolism, SD Standard deviation