This is rivaroxaban, an oral Factor Xa inhibitor, part of the wave of potential warfarin replacements. This is their phase III EINSTEIN-PE trial, which is a non-inferiority comparison against warfarin for the long-term outpatient management of pulmonary embolism.
Overall, it was slightly less effective at prevention of recurrent venous thromboembolism (2.1% vs 1.8%), but slightly safer with regards to bleeding episodes (10.3% vs. 11.4%). Adherence to therapy was reasonable compared to other trials regarding the amount of time patients spent with therapeutic INR between 2.0 and 3.0. So, really, it’s pretty much a wash.
But, of course, when you have a new and expensive therapy that’s essentially similar to the old, cheap option, the conclusion is: “Our findings in this study involving patients with pulmonary embolism, along with those of our previous evaluation involving patients with deep-vein thrombosis, support the use of rivaroxaban as a single oral agent for patients with venous thromboembolism.”
Of course, if you were expecting a different conclusion from an open-label, manufacturer-sponsored study, you are unfortunately mistaken.
So, make sure your hematology group is on board with PCCs, because there doesn’t seem to be any other possible option for reversing life-threatening bleeding – and rivaroxaban is coming, whether it should be or not.
“Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism”