Comparison of the recanalization rate and postthrombotic syndrome in patients with deep venous thrombosis treated with rivaroxaban or warfarin.

BACKGROUND

In this article, we report the outcomes of patients with deep venous thrombosis in the lower limbs treated with the oral anticoagulant rivaroxaban or warfarin, focusing on the recanalization rate (measured with duplex ultrasound) and the incidence of postthrombotic syndrome.

METHODS

This was a prospective, consecutive, randomized, blind cohort study of patients admitted with deep venous thrombosis to the Division of Vascular and Endovascular Surgery, Hospital do Servidor Público Estadual, São Paulo, Brazil, between March 2016 and July 2018. The patients were randomized into 2 groups and treated with oral anticoagulation for 6 months: either rivaroxaban (group 1) or warfarin (group 2). The study was registered at clinicaltrials.gov under NCT 02704598.

RESULTS

Eighty-eight patients with deep venous thrombosis were admitted to the Vascular Surgery Department and randomized into the 2 groups. The follow-up time was 360 days. Analyses were performed at 180 and 360 days. Four patients were excluded from the study during follow-up because of a diagnosis of ovarian cancer (1 patient), head and neck cancer (1 patient), lung cancer (1 patient), and stomach cancer (1 patient). Therefore, 84 patients were evaluated: 46 patients in group 1 and 38 in group 2. The incidence of postthrombotic syndrome was 17.9% (15 cases) in the total cohort, but was significantly higher in group 2 (11 cases, 28.9%) than in group 1 (4 cases, 8.7%; P < .001; odds ratio, 4.278). The rate of total venous recanalization at 360 days was 40.5% (34 patients) in the total cohort, but was significantly higher in group 1 (35 patients, 76.1%) than in group 2 (5 patients, 13.2%; P < .001). The incidence of partial venous recanalization was 46.4% and was significantly higher in group 2 (28 patients, 73.7%) than in group 1 (11 patients, 23.9%; P = .016). Five patients in the total cohort (6%) showed no venous recanalization, all of them in group 2 (P = .016).

CONCLUSION

In this study, patients who received oral rivaroxaban displayed a lower incidence of postthrombotic syndrome and a better total vein recanalization rate after 6 and 12 months than patients who received warfarin.