RESUMO
OBJECTIVE: To evaluate the efficacy of oral rivaroxaban compared to warfarin in patients with deep vein thrombosis (DVT). STUDY DESIGN: Open label randomized controlled study. PLACE AND DURATION OF STUDY: Department of General Medicine, Pakistan Institute of Medical Sciences (PIMS), Islamabad from January 2016 to January 2018. METHODOLOGY: Patients of both genders between 18 and 60 years of age with Doppler ultrasound-confirmed DVT were included in the study. Pregnant patients and those with advanced liver, renal disease, those with a previous history of DVT, malignancy, with a platelets count of less than 50000/ul were excluded from the study. Rivaroxaban was given in a dose of 15 mg twice daily for 21 days followed by 20 mg once daily. Patients in the warfarin group were given heparin for 3 to 5 days followed by warfarin for 3 to 6 months. The primary efficacy outcome was patency of the vessel at 3 and 6 months of treatment. The principal safety outcomes were major and minor bleeding during the study period. RESULTS: A total of 151 patients with acute symptomatic deep vein thrombosis were enrolled in the study. Half of the patients were given warfarin and the other half rivaroxaban for 6 months. At three months, there were no significant differences observed in vessel patency in the rivaroxaban group (22.4%) as compared to warfarin group (26.7%) but after 6 months of therapy, vessel patency was significantly more in the rivaroxaban group. Adverse events did not show any significant differences Conclusion: Rivaroxaban had an efficacy superior to warfarin in terms of vessel patency after six months of therapy but adverse events were similar in both the groups.