Rivaroxaban superior to enoxaparin at preventing VTE after orthopedic surgeries
The researchers conducted a randomized stratified trial to evaluate rivaroxaban compared with enoxaparin among patients immobilized after lower-limb nonmajor orthopedic surgery.
In the study the patients immobilized after orthopedic surgery were randomized to rivaroxaban 10 mg daily/enoxaparin placebo (n = 1,809) versus enoxaparin 4000 IU subcutaneous daily/rivaroxaban placebo (n = 1,795). The total number of enrollees was 3,604 withe mean patient age being 41 years and the total percentage of females participating in the trial was 34%.
The inclusion criteria were adults undergoing nonmajor orthopedic surgery of the lower limbs and requiring thromboprophylaxis for >2 weeks
The Intended treatment duration was 2 weeks to 1 month in 60%, >1 month to 2 months in 37%, and >2 months in 3%. The study was however terminated early in April 2018 due to slow enrollment.
The primary efficacy outcome of major venous thromboembolism (VTE), defined as symptomatic distal or proximal deep vein thrombosis (DVT), pulmonary embolism, or VTE-related death during the treatment period, or asymptomatic proximal DVT at the end of treatment, occurred in 0.2% of the rivaroxaban group compared with 1.1% of the enoxaparin group (p = 0.01).
The primary safety outcome of major and clinically relevant nonmajor bleeding occurred in 1.1% of the rivaroxaban group compared with 1.0% of the enoxaparin group (p = 0.62).
The secondary outcomes were net clinical benefit: 0.8% of the rivaroxaban group compared with 1.8% of the enoxaparin group (p < 0.05)
It was concluded that among patients immobilized after nonmajor orthopedic surgery, rivaroxaban compared with enoxaparin was associated with a reduction in major VTE. Major bleeding was similar between treatment groups. Most patients received rivaroxaban from 2 weeks to 1 month. Rivaroxaban may represent an alternative to enoxaparin among patients at risk for major VTE after nonmajor orthopedic surgery.
For further reference log on to:
Samama CM, Laporte S, Rosencher N, et al., on behalf of the PRONOMOS Investigators. Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery. N Engl J Med 2020; Mar 29:[Epub ahead of print].