Table 7.

Key randomised trials of direct oral anticoagulants in the treatment of acute pulmonary embolism (PE)

Study patients (n)	Treatment arm (vs heparin/warfarin)	Efficacy	Safety
		(study drug vs warfarin)
RE-COVER (2009) n=2564	LMWH≥5 days followed by dabigatran 150 mg twice daily	Recurrent VTE or fatal PE: 2.4% vs 2.1%	Major bleeding: 1.6% vs 1.9%
RE-COVER II (2014) n=2589	LMWH≥5 days followed by dabigatran 150 mg twice daily	Recurrent VTE or fatal PE: 2.3% vs 2.2%	Major bleeding: 15 patients vs 22 patients
EINSTEIN PE (2012)* n=4833	Rivaroxaban 15 mg twice daily for 3 weeks followed by 20 mg once daily	Recurrent VTE or fatal PE: 2.1% vs 1.8%	Major or CRNM bleeding: 10.3% vs 11.4%
AMPLIFY study (2013) n=5400	Apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily	Recurrent VTE or fatal PE: 2.3% vs 2.7%	Major bleeding: 0.6% vs 1.8%
HOKUSAI-VTE (2013) n=8292	LMWH≥5 days followed by edoxaban 60 mg once daily (30 mg once daily if creatinine clearance 30–50 mL/min or body weight<60 kg)	Recurrent VTE or fatal PE: 3.2% vs 3.5%	Major or CRNM bleeding: 8.5% vs 10.3%

*Only EINSTEIN PE included exclusively patients with PE.

CRNM, clinically relevant non-major; LMWH, low-molecular-weight heparin.