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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 ( VKA s), 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 nonmajor 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; p interaction  = 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; p interaction  = 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.

academic emergency medicine

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