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The prothrombin time does not predict the risk of recurrent venous thromboembolism or major bleeding in rivaroxaban-treated patients
- Source :
- Thrombosis Research, 170, 75-83. Elsevier Science, Thrombosis research, 170, 75-83. Elsevier Limited
- Publication Year :
- 2018
- Publisher :
- Elsevier Science, 2018.
-
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).
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Deep vein
Hemorrhage
030204 cardiovascular system & hematology
Gastroenterology
03 medical and health sciences
Young Adult
0302 clinical medicine
Rivaroxaban
Internal medicine
medicine
Humans
030212 general & internal medicine
DEEP-VEIN THROMBOSIS
Young adult
Aged
Prothrombin time
medicine.diagnostic_test
EINSTEIN-DVT
business.industry
Hematology
Venous Thromboembolism
Middle Aged
medicine.disease
XA INHIBITOR RIVAROXABAN
Thrombosis
Pulmonary embolism
medicine.anatomical_structure
ORAL RIVAROXABAN
Female
business
Venous thromboembolism
Major bleeding
medicine.drug
Factor Xa Inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 18792472 and 00493848
- Volume :
- 170
- Database :
- OpenAIRE
- Journal :
- Thrombosis Research
- Accession number :
- edsair.doi.dedup.....b4eb3024084d619a1c28ac2c22b15b0f