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Review examines presentation, course of major bleeding events during anticoagulation therapy
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Compared with major bleeding events in patients prescribed low–molecular-weight heparins/vitamin K antagonists, events associated with the oral anticoagulant rivaroxaban are fewer and have a less severe course, according to study results published in the Journal of Thrombosis and Haemostasis.
“... There is limited information on how bleeding events during therapy with new oral anticoagulants present and how they should be managed,” the researchers write. “There is a need for information regarding reversal of anticoagulant activity in case of emergency procedures or during serious bleeding.”
Elise S. Eerenberg, MD, of the department of vascular medicine at the Academic Medical Center in the Netherlands, and fellow researchers examined data from 8,246 patients collected during two earlier studies. These trials compared rivaroxaban (Xarelto, Janssen Pharmaceuticals) with heparin/vitamin K antagonists for the treatment of venous thromboembolism.
Two researchers conducted a masked classification of major bleeding events from these trials using a priori-defined criteria. Data regarding “the clinical course and measures applied” for each major bleed were compiled, according to study results.
More bleeding events occurred in patients treated with heparin/vitamin K antagonists (1.7%) compared with patients who received rivaroxaban (1%; HR = 0.54; 95% CI, 0.37-0.79). The major bleeding events that occurred in patients treated with rivaroxaban were milder; 23% of those events were adjudicated to the worst categories as compared with 38% of the major bleeding events among patients receiving heparin/vitamin K antagonists (HR = 0.35; 95% CI, 0.17-0.74). The clinical course was determined to be severe in 25% of major bleeding events associated with rivaroxaban, whereas 33% of major bleeds related to heparin/vitamin K antagonists were classified as such (HR = 0.46; 95% CI, 0.22-0.96).
“... In addition to a lower absolute incidence of major bleeding, initial clinical presentation and clinical course are milder in patients who were treated with rivaroxaban as compared with [heparin/vitamin K antagonist]-treated patients,” the researchers write. “The proportion of patients requiring all possible measures to avoid a bad outcome is relatively low. These results may reassure physicians regarding prescribing new oral anticoagulants to patients. Long-term, real-world experience with new oral anticoagulant therapy is still necessary to confirm these findings.” – by Julia Ernst, MS
Disclosure: Eerenberg reports receiving independent research grants from Baxter and Sanquin and lecture fees from CSL Behring. Please see the full study for a list of all other authors’ relevant financial disclosures.
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