Key result
In routine clinical practice, rivaroxaban for deep vein thrombosis was associated with lower annual rates of major bleeding (1.2% vs 3.4%) and VTE (2.4% vs 3.9%) compared to standard anticoagulation.
Why the study?
Does rivaroxaban improve safety and effectiveness compared to standard anticoagulation in patients with symptomatic deep vein thrombosis in routine clinical practice?
Observational (n=941)
Yes
Does rivaroxaban improve safety and effectiveness compared to standard anticoagulation in patients with symptomatic deep vein thrombosis in routine clinical practice?
Absolute Event Rate: 1.2% vs 3.4%
Rivaroxaban demonstrates a favorable benefit-risk profile with lower rates of major bleeding, recurrent VTE, and mortality compared to standard anticoagulation for DVT in routine clinical practice.
Rivaroxaban was associated with lower bleeding and VTE rates in routine DVT care; leaves open causal benefit pending randomized confirmation.
Summary In addition to parenteral anticoagulants and vitamin K antagonists (standard AC), non-vitamin K antagonist oral anticoagulants (NOAC) are increasingly being used for the acute and long-term treatment of deep vein thrombosis (DVT). The international, prospective, non-interventional XALIA study compared the acute and long-term treatment of DVT with rivaroxaban or standard AC under routine clinical practice and confirmed the safety and efficacy of rivaroxaban demonstrated in Phase III studies: annual event rates for major bleeding, VTE and all-cause mortality were 1.2 %, 2.4 % and 0.8 % respectively, compared to 3.4 %, 3.9 %, and 6.2 % with standard AC. The XALIA-DE subgroup analysis examined whether the XALIA results were applicable to Germany. The 586 rivaroxaban patients were younger and fewer had active cancer than the 355 treated with standard AC. As in XALIA, the incidence of major bleeding (1.6 vs. 4.1/100 patient-years [PY]), recurrent VTE (1.9 vs. 4.7/100 PY) and all-cause mortality (1.6 vs. 6.8/100 PY) were lower under rivaroxaban than under standard AC. These rates indicate a favourable benefit-risk profile of rivaroxaban under the conditions of everyday practice.
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Haas et al. (2016) conducted an observational in symptomatic deep vein thrombosis (n=941). Rivaroxaban vs. Standard anticoagulation (parenteral anticoagulants and vitamin K antagonists) was evaluated on major bleeding. In routine clinical practice, rivaroxaban for deep vein thrombosis was associated with lower annual rates of major bleeding (1.2% vs 3.4%) and VTE (2.4% vs 3.9%) compared to standard anticoagulation.
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