Reduced-dose DOACs provided comparable efficacy to full-dose regimens for extended VTE treatment, with recurrent VTE rates of 2.2% vs 1.8% (HR 1.32; 95% CI 0.67-2.60; P=0.23 for non-inferiority).
Systematic Review
Do reduced-dose DOACs provide comparable efficacy and safety to full-dose DOACs for extended treatment of VTE?
Reduced-dose DOACs offer comparable efficacy to full-dose regimens for extended VTE treatment, with a significantly lower risk of bleeding.
Effect estimate: HR 1.32 (95% CI 0.67-2.60)
Absolute Event Rate: 2.2% vs 1.8%
p-value: p=.23 for non-inferiority
Background Venous thromboembolism (VTE) often necessitates extended anticoagulation to reduce the risk of recurrence. While direct oral anticoagulants (DOACs) have largely replaced vitamin K antagonists due to their improved safety and convenience, the optimal long-term dosing strategy (reduced vs full dose) remains uncertain. This systematic review assesses the efficacy and safety outcomes of reduced-dose DOACs compared with full-dose therapy for extended VTE treatment. Methods We conducted a systematic review of randomized controlled trials (RCTs) comparing reduced-dose and full-dose DOACs in patients with VTE. Due to heterogeneity in study designs and outcomes, a narrative synthesis was performed. Results Three RCTs were included. In AMPLIFY-EXT, recurrent VTE or death occurred in 1.7% of patients receiving apixaban (both 2.5 mg and 5 mg) versus 8.8% with placebo. In EINSTEIN CHOICE, recurrent VTE occurred in 1.2% and 1.5% of patients receiving rivaroxaban 10 mg and 20 mg, respectively, compared with 4.4% with aspirin. The safety outcomes were comparable between the two DOAC doses in AMPLIFY-EXT and EINSTEIN CHOICE. RENOVE reported 5-year cumulative incidences of recurrent VTE of 2.2% with reduced-dose and 1.8% with full-dose DOACs (hazard ratio 1.32, 95% confidence interval CI: 0.67-2.60; P = .23 for non-inferiority). Major or clinically relevant non-major bleeding events occurred in 9.9% patients in the reduced-dose group and 15.2% patients in the full-dose group (HR 0.61; 95% CI 0.48-0.79). Conclusion Current evidence suggest that reduced-dose DOACs provide efficacy comparable to full-dose regimens without a corresponding increase in bleeding events in the extended treatment of VTE.
Deng et al. (Fri,) conducted a systematic review in Venous thromboembolism (VTE). Reduced-dose direct oral anticoagulants (DOACs) vs. Full-dose DOACs was evaluated on Recurrent VTE (HR 1.32, 95% CI 0.67-2.60, p=.23 for non-inferiority). Reduced-dose DOACs provided comparable efficacy to full-dose regimens for extended VTE treatment, with recurrent VTE rates of 2.2% vs 1.8% (HR 1.32; 95% CI 0.67-2.60; P=0.23 for non-inferiority).