Considerations for routine coagulation monitoring with rivaroxaban: A case report and review of the literature

Abstract

BACKGROUNDRivaroxaban is a non-vitamin K antagonist oral anticoagulant that does not require coagulation monitoring based on current recommendations. Our goal is to explore whether routine coagulation monitoring should not be required for all patients receiving oral rivaroxaban, what relationship between routine coagulation abnormalities and bleeding, and how to deal with the above clinical situations through our case and review of the literature.CASE SUMMARYWe report a 67-year-old woman with a history of atrial fibrillation who presented to the hospital with worsening dyspnea and cough. Based on electrocardiogram, venous compression ultrasonography, and computed tomography pulmonary angiography, the diagnosis of atrial fibrillation, deep venous thrombosis, and acute pulmonary embolism was confirmed. Her coagulation assays and renal function were normal on admission; she was not underweight, did not have a history of hemorrhagic disease, and her CHA2DS2-VAS, HAS-BLED, and simplified Pulmonary Embolism Severity Index scores were 3, 0, and 0, respectively. Oral rivaroxaban (15 mg twice daily) was administered. The following day, she presented gastrointestinal and gum bleeding, combined with coagulation abnormalities. Following cessation of rivaroxaban, her bleeding stopped and tests improved over the next 2 d. Rivaroxaban was begun again 3 d after recovery. However, she again presented with gastrointestinal and gum bleeding and the abnormal tests, and the therapy was discontinued. At 30-d follow-up after discharge, she presented normal coagulation tests without bleeding.CONCLUSIONAlthough current guidelines recommend that using non-vitamin K antagonist oral anticoagulants including rivaroxaban do not require coagulation monitoring, a small number of patients may develop routine coagulation test changes and bleeding during rivaroxaban therapy, especially in the elderly. Clinicians should pay attention to these patients and further obtain evidence in practice.

Developing Deep Venous Thrombosis while on Rivaroxaban: A Review of Rivaroxaban

“…By contrast, Wu et al [7] reported a clinical case of a 67-year-old female with a normal kidney and liver function tests and normal platelet counts, who was treated with a normal dose of rivaroxaban for Pulmonary Embolism (PE) and bilateral intermuscular veins DVT. However, she developed rare abnormal prolongation coagulation tests of PT, aPPT, and gastrointestinal and gum bleeding after 24 hours of administration [7]. Current guidelines recommend that using DOAC, including rivaroxaban do not require coagulation monitoring, but a small number of patients may develop routine coagulation test changes and bleeding during rivaroxaban therapy, especially in the elderly [7].…”

“…Rivaroxaban is approved with other DOACs such as apixaban and dabigatran in many countries in adult patients for thromboprophylaxis after elective hip or knee replacement surgery, prevention of stroke and systemic embolism with non-valvular atrial fibrillation (AF), for the treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and prevention of recurrent DVT and PE [5][6][7][8][9][10][11][12][13]. Prevention of stroke in AF was by far the most prevalent indication for prescribing a DOAC [14].…”

“…Therefore, factor X represents an ideal target to prevent thrombosis without inducing systemic hypocoagulation and unintended bleeding complications. Constant scientific research has led to improved understanding of coagulation pathways and led to the development of several new parenterally or orally active agents that specifically target single blood coagulation factors [7]. Rivaroxaban inhibits prothrombinase and free and clot-bound Factor Xa activity reversibly [9,15], thus effectively blocking thrombin generation [3,6,8,13,15].…”

“…It has predictable, dose-dependent pharmacokinetics, relatively short halflife; 5-9 h in healthy young subjects and 11-12 h in elderly subjects, rapid onset of action, plasma rivaroxaban levels and inhibition of Factor Xa are closely correlated, wide therapeutic window, a better efficacy/safety ratio, fewer food and drug interactions, and it does neither require routine monitoring nor routine dose adjustment, which may also increase patient's compliance. Also, a dualroute of elimination; the liver metabolizes 2/3 while 1/3 is excreted unaltered by the kidneys [3,[6][7][8][9]11,16] (Figure 1). Bodyweight, gender, and ethnicity had no clinically relevant effects on rivaroxaban pharmacodynamics [15].…”

“…But despite this, rivaroxaban dosages do not need adjustment according to age, because this effect was attributed to a reduced renal function in older patients rather than the effect of age itself [15]. By contrast, Wu et al [7] reported a clinical case of a 67-year-old female with a normal kidney and liver function tests and normal platelet counts, who was treated with a normal dose of rivaroxaban for Pulmonary Embolism (PE) and bilateral intermuscular veins DVT. However, she developed rare abnormal prolongation coagulation tests of PT, aPPT, and gastrointestinal and gum bleeding after 24 hours of administration [7].…”