Background: Isolated distal deep vein thrombosis (IDDVT) accounts for 31 to 56% of all DVTs. Despite the relatively high frequency, its optimal management remains controversial. Observational studies report similar therapeutic strategies as for patients with proximal DVT, but shorter treatment duration.
Aims: To compare the efficacy and safety of two different durations of treatment with rivaroxaban in patients with symptomatic IDDVT.
Methods: In a randomized, double-blind, placebo-controlled trial, patients with a first symptomatic IDDVT were randomized to rivaroxaban 20 mg OD or placebo for 6 weeks after completion of 6 weeks of open rivaroxaban at standard doses. Age <18 years, pregnancy or breast-feeding, active cancer, concomitant proximal DVT or pulmonary embolism (PE), severe renal or liver insufficiency were exclusion criteria. Primary efficacy outcome was the composite of recurrent IDDVT, and occurrence of proximal DVT and symptomatic fatal or non-fatal PE at 6 months. Primary safety outcome was ISTH-defined major bleeding. All outcomes were assessed by an independent adjudication committee.
Results: A total of 390 patients were included, 195 randomized to rivaroxaban and 195 to placebo; mean age was 65 years; 58.5% and 59.5%, respectively, were female. IDDVT was unprovoked in 41.5% of patients in both groups; 16.4% and 12.8%, respectively, had previous VTE. The primary efficacy outcome occurred in 2.6% of patients receiving rivaroxaban and 9.8% receiving placebo (p=0.003). Recurrent IDDVT occurred in 2.1% and 9.3% (p=0.002); proximal DVT in 0.5% and 1.6% (p=0.62); and PE in 0.5% and 0.5% (p=0.99), respectively. There were 3 (0.7%) major bleeding events prior to randomization, none after randomization.
Conclusions: Rivaroxaban administered for 3 months effectively and safely reduces recurrent VTE as compared to 6 weeks of treatment during a 6-month follow up. The incidence of proximal DVT and PE was very low and similar between the two groups.
To cite this abstract in AMA style:Ageno W, Bertù L, Bucherini E, Camporese G, Dentali F, Iotti M, Lessiani G, Parisi R, Prandoni P, Sartori M, Visonà A, Palareti G, RIDTS study group . Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis – RIDTS Study [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 1). https://abstracts.isth.org/abstract/rivaroxaban-for-the-treatment-of-symptomatic-isolated-distal-deep-vein-thrombosis-ridts-study/. Accessed September 24, 2021.
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