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Study flow diagram.
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Figure 1

Study flow diagram.

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'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Oral DTI versus standard anticoagulation, Outcome 1 Recurrent pulmonary embolism.
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Analysis 1.1

Comparison 1 Oral DTI versus standard anticoagulation, Outcome 1 Recurrent pulmonary embolism.

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Comparison 1 Oral DTI versus standard anticoagulation, Outcome 2 Recurrent venous thromboembolism.
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Analysis 1.2

Comparison 1 Oral DTI versus standard anticoagulation, Outcome 2 Recurrent venous thromboembolism.

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Comparison 1 Oral DTI versus standard anticoagulation, Outcome 3 Deep vein thrombosis.
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Analysis 1.3

Comparison 1 Oral DTI versus standard anticoagulation, Outcome 3 Deep vein thrombosis.

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Comparison 1 Oral DTI versus standard anticoagulation, Outcome 4 Major bleeding.
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Analysis 1.4

Comparison 1 Oral DTI versus standard anticoagulation, Outcome 4 Major bleeding.

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Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 1 Recurrent pulmonary embolism.
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Analysis 2.1

Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 1 Recurrent pulmonary embolism.

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Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 2 Recurrent venous thromboembolism.
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Analysis 2.2

Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 2 Recurrent venous thromboembolism.

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Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 3 Deep vein thrombosis.
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Analysis 2.3

Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 3 Deep vein thrombosis.

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Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 4 All‐cause mortality.
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Analysis 2.4

Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 4 All‐cause mortality.

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Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 5 Major bleeding.
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Analysis 2.5

Comparison 2 Oral factor Xa versus standard anticoagulation, Outcome 5 Major bleeding.

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Summary of findings for the main comparison. Oral direct thrombin inhibitors (DTIs) versus standard anticoagulation for the treatment of pulmonary embolism

Oral direct thrombin inhibitors (DTIs) versus standard anticoagulation for the treatment of pulmonary embolism

Patient or population: patients with a pulmonary embolism, confirmed by standard imaging techniques
Setting: hospital
Intervention: oral direct thrombin inhibitors (DTIs)
Comparison: standard anticoagulation

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with standard anticoagulation

Risk with Oral DTI

Recurrent pulmonary embolism1

Study population

OR 1.02
(0.50 to 2.04)

1602
(1 RCT)

⊕⊕⊕⊕
HIGH2 3

The data from the 2 RECOVER studies were taken from 1 pooled analysis and are therefore shown as 1 study

20 per 1000

20 per 1000
(10 to 40)

Recurrent venous thromboembolism
4

Study population

OR 0.93
(0.52 to 1.66)

1602
(1 RCT)

⊕⊕⊕⊕
HIGH2 3

The data from the 2 RECOVER studies were taken from 1 pooled analysis and are therefore shown as 1 study

31 per 1000

29 per 1000
(16 to 50)

Deep vein thrombosis5

Study population

OR 0.79
(0.29 to 2.13)

1602
(1 RCT)

⊕⊕⊕⊕
HIGH2 3

The data from the 2 RECOVER studies were taken from 1 pooled analysis and are therefore shown as 1 study

11 per 1000

9 per 1000
(3 to 23)

All‐cause mortality

See comment

See comment

See comment

‐

The 2 RECOVER studies did not report on all‐cause mortality

Major bleeding6

Study population

OR 0.50
(0.15 to 1.68)

1527
(1 RCT)

⊕⊕⊕⊕
HIGH2 3

The data from the 2 RECOVER studies were taken from 1 pooled analysis and are therefore shown as 1 study

10 per 1000

5 per 1000
(2 to 17)

Health‐related quality of life

See comment

See comment

See comment

‐

The 2 RECOVER studies did not measure health‐related quality of life

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; OR: odds ratio; PE: pulmonary embolism; RCT: randomised controlled trial; VTE: venous thromboembolism

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1Confirmed by ventilation–perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries.
2Risk of bias was 'unclear' for random sequence generation but we did not consider it sufficient to downgrade the quality of evidence.
3The possibility of publication bias is not excluded but we did not consider it sufficient to downgrade the quality of evidence.
4Clinically overt DVT, confirmed by standard imaging techniques including proximal leg vein ultrasound scan or D‐dimer test, or both; or clinically overt pulmonary embolism, confirmed by ventilation–perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries.
5Clinically overt DVT confirmed by standard imaging techniques (proximal leg vein ultrasound scan, venography) or D‐dimer test, or both.
6As defined by the International Society on Thrombosis and Haemostasis (ISTH) (Schulman 2005). Fatal bleeding; symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial, or intramuscular with compartment syndrome; bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells; any combination of points 1 to 3.

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Summary of findings for the main comparison. Oral direct thrombin inhibitors (DTIs) versus standard anticoagulation for the treatment of pulmonary embolism
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Summary of findings 2. Oral factor Xa inhibitors versus standard anticoagulation for the treatment of pulmonary embolism

Oral factor Xa inhibitors versus standard anticoagulation for the treatment of pulmonary embolism

Patient or population: patients with a pulmonary embolism, confirmed by standard imaging techniques
Setting: hospital
Intervention: oral factor Xa inhibitors
Comparison: standard anticoagulation

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with standard anticoagulation

Risk with oral factor Xa

Recurrent pulmonary embolism1

Study population

OR 1.08
(0.46 to 2.56)

4509
(2 RCTs)

⊕⊕⊕⊝
MODERATE 2 3 4

‐

22 per 1000

24 per 1000
(10 to 55)

Recurrent venous thromboembolism5

Study population

OR 0.85
(0.63 to 1.15)

6295
(3 RCTs)

⊕⊕⊕⊕
HIGH 2 4

‐

24 per 1000

20 per 1000
(15 to 27)

Deep vein thrombosis6

Study population

OR 0.72
(0.39 to 1.32)

4509
(2 RCTs)

⊕⊕⊕⊕
HIGH 4

‐

11 per 1000

8 per 1000
(4 to 15)

All‐cause mortality

Study population

OR 1.16
(0.79 to 1.70)

4817
(1 RCT)

⊕⊕⊕⊝
MODERATE 2 4 7

‐

16 per 1000

19 per 1000
(13 to 27)

Major bleeding8

Study population

OR 0.97
(0.59 to 1.62)

4507
(2 RCTs)

⊕⊕⊕⊕
HIGH 2 4

‐

14 per 1000

13 per 1000
(8 to 22)

Health‐related quality of life

See comment

See comment

See comment

‐

The studies did not measure health‐related quality of life

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; OR: odds ratio; PE: pulmonary embolism; RCT: randomised controlled trial; VTE: venous thromboembolism

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1Confirmed by ventilation–perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries.
2Risk of bias was 'unclear' for random sequence generation but we did not consider it sufficient to downgrade the quality of evidence.
3Statistical heterogeneity was found for this outcome and could not be explained.
4The possibility of publication bias is not excluded but we did not consider it sufficient to downgrade the quality of evidence as only two studies were included in this comparison.
5Clinically overt DVT, confirmed by standard imaging techniques including proximal leg vein ultrasound scan or D‐dimer test, or both; or clinically overt pulmonary embolism, confirmed by ventilation–perfusion lung scanning, angiography or spiral computed tomography of pulmonary arteries.
6Clinically overt DVT confirmed by standard imaging techniques (proximal leg vein ultrasound scan, venography) or D‐dimer test, or both.
7Quality of evidence downgraded to moderate as only one study was included.
8As defined by the International Society on Thrombosis and Haemostasis (ISTH); Schulman 2005). Fatal bleeding; symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra‐articular or pericardial, or intramuscular with compartment syndrome; bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells; any combination of points 1 to 3.

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Summary of findings 2. Oral factor Xa inhibitors versus standard anticoagulation for the treatment of pulmonary embolism
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Comparison 1. Oral DTI versus standard anticoagulation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent pulmonary embolism Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Recurrent venous thromboembolism Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 Deep vein thrombosis Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4 Major bleeding Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected
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Comparison 1. Oral DTI versus standard anticoagulation
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Comparison 2. Oral factor Xa versus standard anticoagulation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Recurrent pulmonary embolism Show forest plot

2

4509

Odds Ratio (M‐H, Random, 95% CI)

1.08 [0.46, 2.56]

2 Recurrent venous thromboembolism Show forest plot

3

6295

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.63, 1.15]

3 Deep vein thrombosis Show forest plot

2

4509

Odds Ratio (M‐H, Fixed, 95% CI)

0.72 [0.39, 1.32]

4 All‐cause mortality Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5 Major bleeding Show forest plot

2

4507

Odds Ratio (M‐H, Fixed, 95% CI)

0.97 [0.59, 1.61]
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Comparison 2. Oral factor Xa versus standard anticoagulation
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