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Table 2 Clinical outcomes of patients stratified by baseline symptoms

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

 

PE with/without DVT

DVT

 

Asymptomatic

Symptomatic

HR (95% CI)

P-Value

Asymptomatic

Symptomatic

HR (95% CI)

P-Value

 

n = 197

n = 222

  

n = 203

n = 394

  

Recurrence or aggravation of symptomatic VTE

1.8 (0.7–4.0)

3.1 (1.5–5.5)

0.60 (0.22–1.62)

0.31

1.7 (0.6–3.8)

3.1 (1.9–4.8)

0.56 (0.23–1.40)

0.21

Recurrence or aggravation of symptomatic PE

0.9 (0.2–2.7)

2.5 (1.1–4.5)

0.37 (0.10–1.35)

0.12

0.3 (0.0–1.6)

1.1 (0.4–2.2)

0.26 (0.03–2.15)

0.18

Recurrence or aggravation of symptomatic DVT

1.2 (0.3–3.2)

0.8 (0.2–2.4)

1.49 (0.33–6.67)

0.60

1.4 (0.5–3.4)

2.2 (1.2–3.6)

0.68 (0.24–1.88)

0.45

Acute coronary syndrome

0

0.3 (0.0–1.5)

-

0.35

0.3 (0.0–1.6)

0.2 (0.0–0.8)

1.90 (0.12–30.36)

0.64

Ischemic stroke

1.2 (0.3–3.1)

1.1 (0.3–2.8)

1.11 (0.28–4.45)

0.88

0

0

-

-

Death from any cause

5.2 (3.0–8.3)

4.6 (2.7–7.4)

1.11 (0.57–2.18)

0.76

6.5 (4.1–9.8)

5.6 (4.0–7.7)

1.17 (0.69–1.96)

0.56

Death related to VTE

0.6 (0.1–2.2)

0.5 (0.1–2.0)

1.11 (0.16–7.89)

0.92

0.3 (0.0–1.6)

0.5 (0.1–1.4)

0.62 (0.06–5.94)

0.67

Death related to CVD

0.9 (0.2–2.7)

0.5 (0.1–2.0)

1.67 (0.28–9.99)

0.57

0.3 (0.0–1.6)

1.1 (0.4–2.2)

0.27 (0.03–2.19)

0.19

Major bleeding

1.9 (0.5–4.9)

2.7 (1.1–5.7)

0.68 (0.20–2.33)

0.58

5.2 (1.9–11.4)

3.0 (1.5–5.2)

1.47 (0.54–3.97)

0.45

Minor bleeding

3.4 (1.4–7.0)

9.5 (6.0–14.3)

0.36 (0.15–0.83)

0.004

12.4 (6.8–20.8)

9.1 (6.3–12.6)

1.03 (0.55–1.92)

0.94

Fatal bleeding

0

0

-

-

0

0.5 (0.1–1.3)

-

0.21

Clinically relevant events

7.8 (5.1–11.6)

9.5 (6.5–13.3)

0.83 (0.49–1.39)

0.48

9.9 (6.8–13.9)

9.4 (7.2–12.1)

1.05 (0.69–1.61)

0.82

  1. Data are shown as % per patient-year, 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