January 1, 2016Thrombosis and Haemostasis
Rivaroxaban for the treatment of venous thromboembolism
Key result
In a propensity score-adjusted population, rivaroxaban was associated with a similar risk of recurrent VTE compared to conventional anticoagulation at three months (1.2% vs 2.1%; HR 0.55; 95% CI 0.18-1.65; P=0.29).
Why the study?
Does rivaroxaban reduce recurrent VTE and major bleeding in patients with venous thromboembolism compared to conventional anticoagulation in routine clinical practice?
Population
2,062 consecutive patients with venous thromboembolism from 11 acute care hospitals in Switzerland enrolled…
Comparison
Rivaroxaban vs Conventional anticoagulation
Design
Cohort
Follow-up
3 months
Authors
Discussion
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Implication
Similar recurrent VTE risk in observational data should not change practice; leaves open need for randomized confirmation.
Key Points
- To evaluate three-month clinical outcomes and safety profiles of rivaroxaban compared to conventional anticoagulation in routine clinical practice for venous thromboembolism.
- Prospective observational registry (SWIVTER) of 2,062 consecutive patients with venous thromboembolism across 11 acute care hospitals in Switzerland between November 2012 and February 2015.
- Compared 417 patients treated with rivaroxaban against 1,645 patients receiving conventional anticoagulation using propensity score adjustment over a three-month follow-up.
- In the propensity score-adjusted population, the risk of recurrent venous thromboembolism was 1.2% for rivaroxaban versus 2.1% for conventional anticoagulation (HR 0.55, 95% CI 0.18–1.65; p=0.29).
- Major bleeding occurred in 0.5% of rivaroxaban patients and 0.5% of conventional anticoagulation patients (HR 1.00, 95% CI 0.14–7.07; p=1.00).
Study Design
Type
Cohort (n=2,062)
Multicenter
Yes
Structured PICO
Does rivaroxaban reduce recurrent VTE and major bleeding in patients with venous thromboembolism compared to conventional anticoagulation in routine clinical practice?
P
Population
2,062 consecutive patients with venous thromboembolism from 11 acute care hospitals in Switzerland, followed for three months.
E
Exposure
Rivaroxaban
C
Comparator
Conventional anticoagulation
O
Outcome
Three-month clinical outcomes (recurrent VTE and major bleeding)hard clinical
Main Result
Hazard Ratio: 0.55 (95% CI 0.18–1.65)
Absolute Event Rate: 1.2% vs 2.1%
p-value: p=0.29
In routine clinical practice, rivaroxaban demonstrated comparable 3-month efficacy and safety to conventional anticoagulation for VTE treatment, despite being prescribed to a younger, less comorbid population.
Cite This Study
Aujesky et al. (2016) conducted a cohort in venous thromboembolism (VTE) (n=2,062). Rivaroxaban vs. Conventional anticoagulation was evaluated on recurrent VTE (HR 0.55, 95% CI 0.18-1.65, p=0.29). In a propensity score-adjusted population, rivaroxaban was associated with a similar risk of recurrent VTE compared to conventional anticoagulation at three months (1.2% vs 2.1%; HR 0.55; 95% CI 0.18-1.65; P=0.29).