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)EfficacySafety
(study drug vs warfarin)
RE-COVER (2009)
n=2564
LMWH≥5 days followed by dabigatran 150 mg twice dailyRecurrent 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 dailyRecurrent 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 dailyRecurrent 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 dailyRecurrent 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.