The prothrombin time does not predict the risk of recurrent venous thromboembolism or major bleeding in rivaroxaban-treated patients.

Abstract

INTRODUCTION:

For treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), rivaroxaban is given in fixed doses without routine coagulation monitoring.

PATIENTS AND METHODS:

To determine whether monitoring would enhance its benefit-risk profile, we examined whether peak and trough prothrombin time (PT) values measured in 3797 rivaroxaban-treated patients included in the EINSTEIN DVT and PE studies correlated with subsequent recurrent VTE and major bleeding. In addition, we examined the stability of PT values over time and the impact of clinical variables on PT values.

RESULTS:

The mean peak PT values at months 3 and 6 or 12 were 21.9 ± 5 and 21.7 ± 6.0 s, respectively, while the mean trough PT values at months 2 and 6 were 15.1 ± 5.1 and 15.3 ± 2.9 s, respectively. Although peak and through PT values were higher in females, and with older age, frailty, active cancer, low body weight, impaired renal function and use of moderate to strong inhibitors of CYP3A4 and/or P-glycoprotein, and were lower in patients taking strong CYP 3A4 inducers, the differences were small and results were overlapping. Neither peak nor trough PT values correlated with recurrent VTE or major bleeding.

CONCLUSIONS:

PT monitoring is unlikely to improve the benefit-risk profile of rivaroxaban in patients with DVT or PE. The study was registered at www.clinicaltrials.gov as #NCT00440193 (EINSTEIN-DVT) and #NCT00439777 (EINSTEIN-PE).

• Authors: Hugo Ten Cate, Anthonie W A Lensing, Jeffrey I Weitz, Saskia Middeldorp, Jan Beyer-Westendorf, Dagmar Kubitza, Timothey Brighton, Gary E Raskob, Patrick Mismetti, Paolo Prandoni, Martin Gebel, Martin H Prins
• Journal: Thrombosis research (Thromb Res) Vol. 170 Pg. 75-83 (10 2018) ISSN: 1879-2472 [Electronic] United States
• PMID: 30121419 (Publication Type: Journal Article)
• Copyright: Copyright © 2018 Elsevier Ltd. All rights reserved.

Chemical References

• Factor Xa Inhibitors
• Rivaroxaban

Topics

• Adolescent
• Adult
• Aged
• Factor Xa Inhibitors (pharmacology, therapeutic use)
• Female
• Hemorrhage (chemically induced)
• Humans
• Male
• Middle Aged
• Rivaroxaban (adverse effects, pharmacology, therapeutic use)
• Venous Thromboembolism (drug therapy)
• Young Adult