Key result
Rivaroxaban shows no survival benefit over warfarin in VTE, but links to less major bleeding.
Why the study?
Survival data, recurrence frequency, and bleeding rates comparing warfarin and rivaroxaban in Latin American patients with VTE are limited.
Does rivaroxaban improve survival or reduce bleeding compared to warfarin in patients with venous thromboembolic disease?
Cohort (n=505)
No
Does rivaroxaban improve survival or reduce bleeding compared to warfarin in patients with venous thromboembolic disease?
Absolute Event Rate: 94.7% vs 95.7%
p-value: p=0.61
Rivaroxaban offers similar 12-month survival to warfarin in VTE patients but significantly reduces the risk of major bleeding.
Rivaroxaban-associated lower bleeding may inform VTE anticoagulation choice; leaves open randomized validation of survival equivalence.
BACKGROUND: Venous thromboembolic disease (VTE) is characterized by obstruction of venous blood flow by a thrombus. Survival data, frequency of disease recurrence, and bleeding rate in patients on anticoagulant therapy with warfarin compared to rivaroxaban in the Latin American population are limited in VTE. METHODS: A retrospective cohort study with propensity score matching analysis was conducted in patients with pulmonary embolism and/or deep vein thrombosis anticoagulated with warfarin or rivaroxaban treated. Survival analysis was performed using a Kaplan-Meier curve for each of the intervention groups, and it was compared using a Log Rank test. RESULTS: Of 2193 potentially eligible patients with a suspected diagnosis of VTE, 505 patients entered the analysis; of these, 285 subjects were managed with warfarin and 220 anticoagulated with rivaroxaban. Major bleeding at 12 months occurred in 2.7% (6/220) of patients treated with Rivaroxaban, compared to 10.2% (29/285) in the Warfarin group in the unmatched population (p = 0.001). In the matched population, bleeding at 12 months occurred in 2.9% (6/209) of patients on Rivaroxaban and in 11.0% (23/209) of patients on Warfarin (p = 0.001). The survival rates at 6 months were 97.1% for Rivaroxaban and 97.6% for Warfarin (p = 0.76). At 12 months, the survival rates were 94.7% for Rivaroxaban and 95.7% for Warfarin (p = 0.61). CONCLUSION: In the treatment of VTE, there is no differences on 6 and 12-month survival or a reduction in the occurrence of new thromboembolic events when comparing rivaroxaban to warfarin. However, a lower risk of major bleeding is observed at 12 months with Rivaroxaban.
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Ramos-Isaza et al. (2023) conducted a cohort in Venous thromboembolic disease (VTE) (n=505). Rivaroxaban vs. Warfarin was evaluated on Survival at 12 months (p=0.61). Rivaroxaban showed no significant difference in 12-month survival compared to warfarin (94.7% vs 95.7%, p=0.61) in patients with venous thromboembolic disease, but was associated with a lower risk of major bleeding.
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