Rivaroxaban noninferior to fondaparinux for superficial vein thrombosis

A 45-day course of rivaroxaban for the treatment of high-risk patients with superficial vein thrombosis did not increase the risk for serious complications or major bleeding events compared with fondaparinux over the same timeframe, according to findings from the SURPRISE trial presented at the ASH Annual Meeting and Exposition.

Fondaparinux (Arixtra, GlaxoSmithKline) – an indirect Factor Xa inhibitor – has been the standard of therapy for the treatment superficial vein thrombosis.

However, the researchers noted that fondaparinux is rather expensive, requires daily injections and its cost effectiveness in superficial vein thrombosis therapy has been questioned.

Jan Beyer-Westendorf, MD, of the Carl Gustav Carus Hospital in Germany, and colleagues conducted a randomized, open-label outcome event adjudication trial to compare once daily rivaroxaban (Xarelto, Janssen) at 10 mg with once daily fondaparinux at 2.5 mg in 472 patients with superficial vein thrombosis at an increased risk for venous thromboembolism (VTE) complications.

The researchers sought to assess if treatment with rivaroxaban would be as safe and effective as treatment with fondaparinux.

Treatment duration for both subgroups (n = 236 for each) was 45+5 days with an observational period until day 90+10.

Primary efficacy outcomes included composite endpoints of deep vein thrombosis, pulmonary embolism, superficial vein thrombosis progression toward the saphenofemoral junction and superficial vein thrombosis recurrence or all-cause death in the per-protocol analysis at day 45.

Primary safety outcome was the rate of International Society of Thrombosis and Haemostasis major bleeding during treatment.

During the first assessment at day 45+5, the primary efficacy outcome (n = 435 in per-protocol analysis set) occurred in 3.3% of patients treated with rivaroxaban and 1.8% of patients who received fondaparinux.

At day 90+10, 7.1% of patients who received rivaroxaban reached primary efficacy outcome, as well as 6.7% of patients who received fondaparinux.

There were no major bleeding events in either group. Non-major, clinically relevant bleeding at 45+5 days occurred in 2.5% of patients who received rivaroxaban and 0.4% of individuals who received fondaparinux.

At day 90+10, patients who received fondaparinux experienced a slight increase in non-major, clinically relevant bleeding (0.9%). However, the rate of non-major bleeding events remained the same as during the first assessment in patients who received rivaroxaban.

“Few cases of DVT and PE occurred, which indicates that a 45-day course of rivaroxaban 10 mg or fondaparinux 2.5 mg is sufficient to prevent serious complications in this specific subset of SVT patients,” the researchers wrote. “As to whether oral rivaroxaban offers a better quality of life compared to 45 days of injections, this has to be investigated in future studies.” – by Ryan McDonald

Reference:

Beyer-Westendorf J, et al. Abstract 85. Presented at: ASH Annual Meeting and Exposition; Dec. 3-6, 2016; San Diego.

Disclosure: Beyer-Westendorf reports receiving honoraria, consultancy and research funding from Bayer, Boehringer Ingelheim, Daichii Sankyo, LEO Pharma and Pfizer. Please see the full study for a list of all other relevant financial disclosures.