Residual vein thrombosis and the risk of subsequent serious complications

none6nonePrandoni, Paolo; Lensing, Anthonie W.A.; Prins, Martin H.; Villalta, Sabina; Harenberg, Job; Noventa, FrancoPrandoni, Paolo; Lensing, Anthonie W. A.; Prins, Martin H.; Villalta, Sabina; Harenberg, Job; Noventa, Franc

Use of Prestudy Heparin Did Not Influence the Efficacy and Safety of Rivaroxaban in Patients Treated for Symptomatic Venous Thromboembolism in the EINSTEIN DVT and EINSTEIN PE Studies

Objectives: In the EINSTEIN DVT and EINSTEIN PE studies, the majority of patients received heparins to bridge the period during venous thromboembolism (VTE) diagnosis confirmation and the start of the study. In contrast to vitamin K antagonists (VKAs), rivaroxaban may not require initial heparin treatment. Methods: To evaluate the effect of prestudy heparin on the efficacy and safety of rivaroxaban relative to enoxaparin/VKA, the 3-month incidence of recurrent VTE, and the 14-day incidence of major and non-major clinically relevant bleeding were compared in patients who did and did not receive prestudy heparin. Results: Of the 8,281 patients randomized, 6,937 (83.8%) received prestudy heparin (mean +/- SD duration = rivaroxaban: 1.04 [+/- 0.74] days; enoxaparin 1.03 [+/- 0.42] days), and 1,344 (16.2%) did not. In patients who did not receive prestudy heparin, the incidences of recurrent VTE were similar in rivaroxaban (15 of 649, 2.3%) and enoxaparin/VKA (13 of 695, 1.9%) patients (adjusted hazard ratio [HR] = 1.11; 95% confidence interval [CI] = 0.52 to 2.37). The incidences of recurrent VTE were also similar in rivaroxaban (54 of 3,501, 1.5%) and enoxaparin/VKA (69 of 3,436, 2.0%) patients who did receive prestudy heparin (adjusted HR = 0.74; 95% CI = 0.52 to 1.06; pinteraction = 0.32). The incidences of major or nonmajor clinically relevant bleeding with rivaroxaban were not significantly different from those with enoxaparin/VKA, either with (105 of 3,485, 3.0% vs. 104 of 3,428, 3.0%; adjusted HR = 0.98; 95% CI = 0.75 to 1.29) or without (24 of 645, 3.7% vs. 30 of 688, 4.4%; adjusted HR = 0.81; 95% CI = 0.46 to 1.40; pinteraction = 0.68) prestudy heparin. Conclusions: Although the majority of patients in the EINSTEIN studies received prestudy heparin, there were no notable differences in treatment effect of rivaroxaban versus enoxaparin/VKA in those who did and did not receive it. (C) 2015 by the Society for Academic Emergency Medicin

Heavy menstrual bleeding in women on anticoagulant treatment for venous thromboembolism: Comparison of high- and low-dose rivaroxaban with aspirin

Contains fulltext : 232761.pdf (Publisher’s version ) (Open Access)BACKGROUND: Rivaroxaban may induce heavy menstrual bleeding. It is unknown if this effect is dose related or if rivaroxaban is associated with more menstrual bleeding than aspirin. OBJECTIVES: To demonstrate and compare menstrual patterns and actions taken among women receiving aspirin and two doses of rivaroxaban. METHODS: The EINSTEIN-CHOICE trial compared once-daily rivaroxaban 20 mg, rivaroxaban 10 mg, and aspirin 100 mg for extended treatment of venous thromboembolism in patients who had completed 6 to 12 months of anticoagulant therapy. In 362 women with menstrual cycles, menstrual flow duration and intensity assessed at days 30, 90, 180, and 360 were compared with those before starting anticoagulant therapy. RESULTS: Menstrual flow duration increased in 12%-18% of the 134 women given 20-mg rivaroxaban, in 6% to 12% of 120 women given 10-mg rivaroxaban, and in 9% to 12% of 108 women given aspirin. Corresponding increases in flow intensity were 19% to 24%, 14% to 21%, and 13% to 20%. The odds ratios (ORs) for increased menstrual flow duration were 1.36 (95% confidence interval [CI], 0.62-2.96) for rivaroxaban 20 mg versus aspirin, 0.77 (95% CI, 0.33-1.81) for rivaroxaban 10 mg versus aspirin, and 0.57 (95% CI, 0.26-1.25) for rivaroxaban 10 mg versus 20 mg. The ORs for increased menstrual flow intensity were 1.41 (95% CI, 0.67-2.99), 1.07 (95% CI, 0.49-2.34), and 0.76 (95% CI, 0.37- 1.57), respectively. CONCLUSIONS: There were no statistically significant differences in menstrual hemorrhage patterns between women treated with 10 or 20 mg of rivaroxaban and aspirin. Compared with 10-mg rivaroxaban or aspirin, 20-mg rivaroxaban showed numerically more often increased menstrual flow duration and intensity