Abstract
Background Pulmonary embolism (PE) is a life-threatening disease. Target-specific anticoagulant rivaroxaban is a direct factor Xa inhibitor that can be safely used without laboratory monitoring. Objective To investigate the efficacy and safety of rivaroxaban versus warfarin for the treatment of acute pulmonary thromboembolism in real-world clinical practice. Method This was a semiretrospective, semiprospective, and real-world trial involving 128 patients with acute symptomatic pulmonary embolism with or without active tumor or frailty. We compared rivaroxaban to the standard therapy consisting of low-molecular-weight heparin combined with warfarin. The primary efficacy outcome was absorption of thrombus. The principal safety outcome was bleeding episode. Results There was no significant difference in thrombus absorption between rivaroxaban and standard therapy after 3-month treatment (P = 0.798, 95% confidence interval (CI) 0.686 to 1.336) or more than 6-month treatment (P = 0.534, 95% confidence interval (CI) 0.795 to 1.556). There was no decline in efficacy (including computed tomographic pulmonary angiography and recurrence) when the rivaroxaban dose was reduced to 10 mg once daily after 3 months of administration. The ratio of patients without bleeding was 48.84% for rivaroxaban and 19.05% for standard therapy (P = 0.001). There was no significant difference in rivaroxaban monotherapy subgroups (including frail patients, tumor patients, and thrombolysis or nonthrombolysis at intermediate-high-risk patients). Conclusion In this real-world study, the efficacy and safety of rivaroxaban alone was not different to standard therapy for pulmonary emboli absorption. With an extension in treatment duration, the rivaroxaban regimen had a higher efficacy and safety than standard therapy and there was no decline in treatment efficacy when the rivaroxaban dose was reduced to 10 mg once daily.
Highlights
Pulmonary embolism (PE) is a disease with high morbidity and mortality [1]
The results showed that the efficacy of rivaroxaban monotherapy was better than standard therapy and had a lower incidence of bleeding
Inclusion criteria were ≥18 years, acute pulmonary embolism diagnosed by computed tomographic pulmonary angiography (CTPA), and ventilation/perfusion (V/Q), with treatment of rivaroxaban monotherapy or standard-therapy
Summary
Pulmonary embolism (PE) is a disease with high morbidity and mortality [1]. Because the usage of rivaroxaban is increasing in actual clinical practice, it is necessary to compare the rivaroxaban monotherapy regimen with standard therapy [2]. Even though several guidelines for the treatment of acute pulmonary embolism with rivaroxaban have been published, there are many PE patients with specific clinical characteristics including frailty (e.g., elderly, low body weight), oncology, or at intermediate-high-risk. Elderly patients have a high incidence of bleeding [3], which increases when coupled with warfarin treatment; there are no guidelines for reducing the anticoagulant dose for that population. To investigate the efficacy and safety of rivaroxaban versus warfarin for the treatment of acute pulmonary thromboembolism in real-world clinical practice. This was a semiretrospective, semiprospective, and real-world trial involving 128 patients with acute symptomatic pulmonary embolism with or without active tumor or frailty. In this real-world study, the efficacy and safety of rivaroxaban alone was not different to standard therapy for pulmonary emboli absorption. With an extension in treatment duration, the rivaroxaban regimen had a higher efficacy and safety than standard therapy and there was no decline in treatment efficacy when the rivaroxaban dose was reduced to 10 mg once daily
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