Pulmonary vascular disease & thromboembolismRandomised controlled trial
Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery
- Randomised controlled trial
- international
- parallel-group
- double-blind
- non-inferiority
Authors' conclusion
Rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilization after nonmajor orthopedic surgery of the lower limbs.
Study context
- Population
- Adults undergoing lower-limb nonmajor orthopedic surgery, at risk for VTE by investigator's judgment
- Participants
- 3,604 adults
- Comparison
- Rivaroxaban vs enoxaparin
- Rivaroxabann = 1,809
- Enoxaparinn = 1,795reference
- Primary endpoint
- Major VTE: symptomatic distal or proximal DVT, PE or VTE-related death during treatment, or asymptomatic proximal DVT at end of treatment
- Follow-up
- Treatment period
Primary result
Major VTE
Relative risk
0.25
95% CI 0.09–0.75
P < 0.001
Events by treatment group
Rivaroxaban vs Enoxaparin
RR 0.25 (95% CI 0.09–0.75); P < 0.001
As reported in the abstract
Safety
Major or nonmajor clinically relevant bleeding
Major bleeding
Major or nonmajor clinically relevant bleeding
- Did not differ significantly
Major bleeding
- Did not differ significantly
Original publication
Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery. N Engl J Med. Published 29 March 2020. doi:10.1056/nejmoa1913808
Summarised from the published abstract; every number is checked against it