Oral rivaroxaban for the treatment of deep vein thrombosis in outpatients: a propensity score-matched comparison with a historical inpatient population.

Abstract

Background: Despite the guidelines' appeal to treat patients with deep vein thrombosis and low-risk pulmonary embolism in outpatient settings, the real-world evidence shows a high prevalence of inpatient therapy leading to unwarranted health resource utilization. The study aimed to assess the efficacy and safety of rivaroxaban in outpatient settings compared to inpatient treatment.

Methods: A propensity score-matched comparison with a historical inpatient population was performed based on a retrospective analysis of patients with deep vein thrombosis and without pulmonary embolism treated as outpatients with oral rivaroxaban. Inpatient controls were treated with oral rivaroxaban following a short-term initial therapy with low-molecular-weight heparins. The relevant outcomes extracted from electronic medical records were as follows: recurrent deep vein thrombosis and symptomatic pulmonary embolism, major bleeding, clinically relevant non-major bleeding, minor bleeding, unscheduled hospitalization, and death.

Results: Among 209 outpatients who were never admitted to the hospital the deep vein thrombosis recurrence rate was 3.3% (95%CI, 1.6-6.8%), clinically relevant non-major bleeding rate 2.9% (95%CI, 1.3-6.1), minor bleeding rate 6.2% (95%CI, 3.7-10.0%), unscheduled hospitalization rate 1.4% (95%CI, 0.5- 4.1%), mortality rate 1.4% (95%CI, 0.5-4.1%). No symptomatic pulmonary embolism or major bleeding was detected. No statistically significant differences were observed when compared with inpatient controls.

Conclusions: The outpatient use of rivaroxaban for deep vein thrombosis treatment is a safe and effective approach for patients without pulmonary embolism, with no significant differences when compared to inpatient therapy with oral rivaroxaban following a short-term initial therapy with low-molecular-weight heparins.