Clinical impact and course of major bleeding with rivaroxaban and vitamin K antagonists. (22nd August 2015)

• Record Type: Journal Article
• Authors: Eerenberg, E. S.; Middeldorp, S.; Levi, M.; Lensing, A. W.; Büller, H. R.
• Is Part Of: Journal of thrombosis and haemostasis. Volume 13:Number 9(2015:Sep.)
• Page Start: 1590
• Page End: 1596
• Publication Date: 2015-08-22
• Subjects: Thrombosis -- Periodicals; Hemostasis -- Periodicals; Blood coagulation disorders -- Periodicals; 616.1
• DOI: 10.1111/jth.13051
• Languages: English
• ISSNs: 1538-7933

Abstract

<abstract abstract-type="main" id="jth13051-abs-0001"> <title>Summary</title> <sec id="jth13051-sec-0001" sec-type="section"> <title>Background</title> <p>Rivaroxaban is a new oral anticoagulant (NOAC) that can be prescribed in a fixed dose, making regular monitoring and dose adjustments unnecessary. It has been proven to be safe and effective in comparison with enoxaparin/vitamin K antagonists (LMWH/VKA) for the (extended) treatment of venous thromboembolism in the EINSTEIN studies. Nevertheless, there is a need for information regarding the clinical impact of (major) bleeding events with NOACs such as rivaroxaban.</p> </sec> <sec id="jth13051-sec-0002" sec-type="section"> <title>Objectives</title> <p>A <italic>post‐hoc</italic> analysis was performed to compare the severity of clinical presentation and subsequent clinical course of major bleeding with rivaroxaban vs. LMWH/VKA.</p> </sec> <sec id="jth13051-sec-0003" sec-type="section"> <title>Methods</title> <p>Two investigators performed a blinded classification of major bleeding using <italic>a priori</italic> defined criteria. During the EINSTEIN studies, data concerning the clinical course and measures applied were prospectively collected for each major bleed.</p> </sec> <sec id="jth13051-sec-0004" sec-type="section"> <title>Results</title> <p>Treatment with LMWH/VKA caused more major bleeding events (1.7%) than rivaroxaban (1.0%; hazard ratio, 0.54; 95% confidence interval [CI], 0.37–0.79). Major bleeding events during rivaroxaban therapy had a milder presentation (23% were adjudicated to the worst categories vs. 38% for LMWH/VKA; hazard ratio or HR, 0.35; 95% CI, 0.17–0.74; <italic>P</italic> = 0.0062). The clinical course was severe in 25% of all major bleeding events associated with rivaroxaban, compared with 33% of LMWH/VKA‐associated bleeds (HR, 0.46; 95% CI, 0.22–0.96; <italic>P</italic> = 0.040).</p> </sec> <sec id="jth13051-sec-0005" sec-type="section"> <title>Conclusions</title> <p>Rivaroxaban‐associated major bleeding events occurred less frequently, had a milder presentation and appeared to take a less severe clinical course compared with major bleeding with LMWH/VKA.</p> </sec> </abstract>