EFFICACY AND SAFETY OF DOACS FOR THE TREATMENT OF SUPERFICIAL VEIN THROMBOSIS: A SYSTEMATIC REVIEW AND META-ANALYSIS

Background: Direct oral anticoagulants (DOACs) are increasingly used for superficial vein thrombosis (SVT), yet evidence remains limited. This systematic review and meta-analysis synthesizes all available data on the efficacy and safety of DOACs in SVT. Methods: A systematic search identified randomized and observational studies enrolling adults with acute SVT treated with DOACs. Primary efficacy outcomes were venous thromboembolism (VTE: deep vein thrombosis or pulmonary embolism) and SVT recurrence/extension. Safety outcomes included major and clinically relevant non-major bleeding (CRNMB). Results: Six studies (n = 2040; 602 DOAC-treated patients) met the inclusion criteria. Compared with fondaparinux, DOACs showed comparable short-term efficacy for VTE prevention (pooled RR 0.93, 95% CI 0.44-1.99) and similar rates of SVT recurrence (RR 1.30, 95% CI 0.65-2.62). Versus placebo, rivaroxaban reduced recurrence by ~80 % (RR 0.20, 95% CI 0.03-1.35). In the pooled safety analysis including four studies, DOACs were associated with a 65% relative risk reduction in major or CRNMB compared with fondaparinux or LMWH (RR 0.35, 95% CI 0.15-0.83; I² = 0 %).In the TROLL registry (n = 229; 74 % DOAC), no major bleeding occurred among DOAC users, while 5-year cumulative VTE and SVT recurrence rates were each 15.9 %. Certainty of evidence was moderate for efficacy and high for safety. Conclusions: DOACs demonstrate efficacy comparable to fondaparinux and an excellent safety profile in SVT, supporting their use as a practical oral alternative. Long-term data indicate persistent thrombotic risk, suggesting potential benefit of extended low-dose prophylaxis in selected high-risk patients.