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.