부산대학교 도서관

Introduction:An individualized approach to patient selection for extended thromboprophylaxis (ET) in acutely ill medical patients that optimizes benefit and risk is challenging. The MAGELLAN study demonstrated significant efficacy with rivaroxaban but had excess bleeding. The MARINER study used the modified IMPROVE VTE risk score and elevated D-dimer (DD) to select higher risk patients and incorporated 5 additional exclusion criteria to reduce bleeding (subjects with active cancer, bronchiectasis, active GI ulcer, the use of dual antiplatelet therapy or a history of bleeding within 3 months).Hypothesis:This retrospective analysis sought to investigate whether application of these inclusion and exclusion criteria to the MAGELLAN population could identify a subgroup with a better benefit risk profile.Methods:We excluded subjects meeting one of the 5 exclusion criteria from all analyses. Then, using the modified intent-to-treat population, we compared the primary composite efficacy endpoint and its components from the MAGELLAN study with rivaroxaban (10mg QD for 35?4 days) compared with enoxaparin (40mg QD for 10?4 days followed by placebo) in 2 subgroups: one with an IMPROVE VTE model score of ?4 or a score of 2 or 3 with a DD >2 times the upper limit of normal and one not meeting criteria. Major bleeding (MB) was assessed on treatment plus 2 days.Results:The IMPROVE+DD subgroup represented 56% of the study population with a significant 32% reduction in the primary endpoint with rivaroxaban (Table).MB was not significantly higher with rivaroxaban in either subgroup although numerically higher in the IMPROVE + DD group.Conclusions:The IMPROVE VTE score + DD and key exclusion criteria used in the MARINER study identified a nearly 3-fold higher VTE risk subpopulation of acutely ill medical patients where a significant benefit exists for ET using rivaroxaban with a similar rate of MB to enoxaparin, thus identifying a subpopulation with a better benefit risk profile.