How does rivaroxaban compare to fondaparinux in the treatment of superficial venous thrombosis in patients at risk for venous thromboembolism (VTE)?

Updated: Apr 17, 2019
  • Author: Khanjan H Nagarsheth, MD, MBA; Chief Editor: Vincent Lopez Rowe, MD  more...
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Answer

The SURPRISE trial was a randomized, open-label, blinded outcome event adjudication trial that compared rivaroxaban 10 mg once daily with fondaparinux 2.5 mg once daily in 472 patients with superficial vein thrombosis who were at risk for venous thromboembolism (VTE) and complications. [32]  Both groups were treated for 45 + 5 days and had an observational period of 90 + 10 days.

The investigators looked at primary efficacy outcome as a composite endpoint of deep venous thrombosis (DVT), pulmonary embolism (PE), progression of superficial vein thrombosis towards the saphenofemoral junction, recurrence of superficial venous thrombosis and all-cause mortality at day 45. [32] The trial was designed to show noninferiority of rivaroraxaban compared to fondaparinux in terms of primary endpoints and risk of major bleeding.

The investigators found that the primary efficacy outcome occurred in 3.3%  of patients receiving rivaroxaban and 1.8% of patients receiving fondaparinux. [32] On the basis of this finding, the absolute difference between rivaroxaban and fondaparinux was 1.53% (P = .025 for noninferiority). Rivaroxaban 10 mg once daily was shown to be noninferior to fondaparinux 2.5 mg once daily for treatment of superficial venous thrombosis. Major bleeding rates were 2.5% at 45 days and 2.5% at 90 days for rivaroxaban versus 0.4% at 45 days and 0.9% at 90 days for fondaparinux.

Noninferiority was shown for rivaroxaban with no statisically significantly increased rate of major bleeding as compared with fondaparinux. [32] No data were collected on comparative quality of life between the two medication regimens. This is an important consideration, in that rivaroxaban is given orally once daily and fondaparinux as a subcutaneous injection once daily. The authors state that this consideration will have to be addressed in further studies.


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