Key result
Extended therapy with rivaroxaban compared to warfarin resulted in no significant difference in the 6-month composite primary endpoint of recurrent venous thromboembolism and major bleeding (HR 1.22).
Why the study?
The benefits and risks of an extra 6 months of warfarin versus rivaroxaban had not been compared in patients with an initial unprovoked pulmonary embolism who completed 3 or 6 months of standard heparin/vitamin K antagonist therapy.
Does extended therapy with rivaroxaban reduce recurrent venous thromboembolism and major bleeding compared to warfarin in patients with initial unprovoked pulmonary embolism?
Cohort (n=212)
No
Does extended therapy with rivaroxaban reduce recurrent venous thromboembolism and major bleeding compared to warfarin in patients with initial unprovoked pulmonary embolism?
In patients with unprovoked PE, extending anticoagulation with rivaroxaban for 6 months showed similar efficacy to warfarin with a trend toward less major bleeding, though the protective effect was lost after discontinuation.
Extended anticoagulation choice in unprovoked PE warrants caution; leaves open need for RCTs to confirm similar recurrence and bleeding risks.
Purpose: To compare the benefits and risks of extra 6 months of warfarin therapy with those of rivaroxaban treatment in patients with initial unprovoked pulmonary embolism (PE) episode who completed 3- or 6-month of therapy on heparin/vitamin K antagonist standard regime.Methods: This prospective observational study included 212 patients with follow-up from July 2013 to July 2018. The primary endpoint was symptomatic recurrent venous thromboembolism (VT), composite of non-fatal symptomatic PE or deep vein thrombosis or fatal VT, and major bleeding (non-fatal/fatal) up to 6 months. Secondary endpoints were death not related to PE or major bleeding.Results: During the 6-month therapy period, the primary endpoint was seen in 3 out of 106 patients (2.83 %) in warfarin category, and in rivaroxaban category, for a hazard ratio (HR) of 1.22 [95 % confidence interval (CI) = 0.09 - 11.18; p = 0.813]. With warfarin therapy, 2 patients (1.89 %) had recurrent VT, while 3 patients (2.83 %) had VT with rivaroxaban. Major bleeding was observed in 2 patients (1.89 %) on warfarin, and in one patient (0.94 %) on rivaroxaban. During the entire 18-month period, the primary endpoint was seen in 15 patients (14.15 %) treated with warfarin, and in 18 patients (16.98 %) treated with rivaroxaban (HR 0.84; 95 % CI = 0.47 - 1.84; p = 0.431). Major bleeding was observed in 5 patients (4.72 %) under warfarin (one fatal), relative to 3 patients (2.83 %) under rivaroxaban (R 1.67; 95 % CI = 0.62 - 5.95; p = 0.09).Conclusion: Rivaroxaban showed higher efficacy than warfarin in recurrent VT prevention, with lower risk of major bleeding. However, the extended therapeutic benefit was not maintained post-therapy. Keywords: Pulmonary embolism, Rivaroxaban, Warfarin, Heparin, Vitamin K, Hazard ratio
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Pan et al. (2020) conducted a cohort in initial unprovoked pulmonary embolism (n=212). Rivaroxaban vs. Warfarin was evaluated on symptomatic recurrent venous thromboembolism (VT), composite of non-fatal symptomatic PE or deep vein thrombosis or fatal VT, and major bleeding (non-fatal/fatal) up to 6 months (HR 1.22, 95% CI 0.09 - 11.18, p=0.813). Extended therapy with rivaroxaban compared to warfarin resulted in no significant difference in the 6-month composite primary endpoint of recurrent venous thromboembolism and major bleeding (HR 1.22).
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