XARELTO®: Clinical trials for initial treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Proven clinical outcomes in dedicated DVT/PE trials1-4
Limitations: The sample size was decreased due to slower than anticipated enrollment and unanticipated funding limitations, though the primary endpoint was met. The unexpectedly large effect size is most likely the result of practice differences in the rates of ED PE discharge in the United States compared with European studies used for its prediction. Also, ED physicians could exclude patients based on a subjective evaluation of hemodynamic stability and their impression of the patient’s ability to adhere to the protocol. Additionally, the use of an endpoint committee did not eliminate potential bias because a patient would know their admission status and could not be blinded to their assigned cohort. Though some may consider the fact that 75% of the control group were discharged on a DOAC as a limitation, and that randomization alone may have contributed to group differences, this reflects current ED practice patterns. Finally, the pragmatic nature of the trial called for the physician to define SOC, which may have contributed to bias to the null.
*The decision regarding initiation setting should be based on the prescriber's clinical judgment.
CrCl = creatinine clearance; DOAC = direct oral anticoagulant; DVT = deep vein thrombosis; ED = emergency department; HCP = healthcare professional; INR = international normalized ratio; ISTH = International Society on Thrombosis and Haemostasis; PE = pulmonary embolism; SOC = standard of care; VKA = vitamin K antagonist; VTE = venous thromboembolism.