OBJECTIVES: The introduction of prothrombin time (INR) point-of-care devices permits patient self-testing of the INR values and subsequently, also self-adjustment of the dosing regimen. The purpose of this systematic review was to evaluate recent findings regarding the effects of self-monitoring and self-management of anticoagulation therapy with vitamin K antagonists (coumarins) compared to the standard ambulatory care. METHODS: A comprehensive literature search using OVID MEDLINE (1946 – April 2015) and EMBASE (1974 – April 2015) databases was performed. Selection criteria were restricted to randomized controlled clinical trials evaluating self-monitoring or self-management with standard care as control. Meta-analysis was performed in Review Manager Computer program (Version 5.3.) using a fixed-effect model with the Mantel-Haenszel method to calculate the pooled risk ratios (RR) and their 95% confidence interval (CI) of the following clinical outcomes: thromboembolic events, major haemorrhage, and all-cause mortality. Potential heterogeneity was assessed with I statistics. RESULTS: In addition to the 2010 Cochrane review (Self-monitoring and self-management of oral anticoagulation), 10 novel randomized trials were identified; in 3 of them self-monitoring was evaluated, while in the other 7 studies self-management was assessed. Until the April 2015, self-monitoring and self-management was evaluated in 10 (4313 participants) and 19 (5413 participants) randomized trials, respectively. Self-management was associated with significant reductions in both thromboembolic events (RR=0.48, 95%CI: 0.35–0.65, p<0.001) and mortality (RR=0.70, 95%CI: 0.49–0.99, p=0.046), while no significant effect on major bleedings was found (RR=1.03, 95%CI: 0.77–1.38). In contrast to the 2010 Cochrane review no significant benefit of self-monitoring could be confirmed: the RRs were 0.91 (95%CI: 0.71–1.16), 0.91 (95%CI: 0.75–1.10), and 0.94 (95%CI: 0.75–1.17) for the thromboembolic events, major bleedings, and mortality, respectively. CONCLUSIONS: Compared to the standard ambulatory care, patient self-management of the INR values shows beneficial effects on their anticoagulant therapy. Moreover, self-management better improves the probability of the occurrence of thromboembolic events than self-monitoring.