Home Treatment of Low-Risk DVT and PE with Xarelto?
The Article: Beam, D., et al. “Immediate Discharge and Home Treatment with Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis.” Academic Emergency Medicine 2015;22:789-795.
The Idea: Systematic reviews and meta-analyses suggest low failure rate associated with outpatient treatment of patient with low-risk VTE, but arranging follow-up to check INR while on warfarin can be challenging. Data from the EINSTEIN trial comparing Rivaroxaban (Xarelto) versus Enoxaparin (Lovenox) bridge to Warfarin therapy suggests that Xarelto may also be a safe option for outpatient treatment of PE and DVT.
The Study: This study was a prospective observational study from March 2013- April 2014. At two academic ED’s in Indiana, patients were diagnosed with DVT or PE via ultrasound or CT Angio/ VQ scan, respectively. Modified Hestia criteria was used to identify low-risk patients that were appropriate for outpatient management. Patients with active malignancy were further screened for appropriateness of outpatient management with the POMPE-C tool.
These patients received one dose of 15mg rivaroxaban po, +/- 1mg/kg enoxaparin subq prior to discharge from the ED. They were discharged with prescriptions for the same rivaroxaban course as in the EINSTEIN trial: 15mg po bid x21 days, then 20mg po qd x1 month. Additional rivaroxaban prescriptions were given at follow-up visits, where decision regarding course duration was made on a case-by-case basis. Patients were closely followed with phone calls, clinic visits, and/or chart review.
Primary endpoints included:
Recurrent VTE while on rivaroxaban (repeat imaging showing acute DVT or PE)
Significant bleeding while on rivaroxaban (>2g/dL acute drop in Hb, >2U blood transfusion, bleeding in critical area, bleeding that contributed to death, bleeding that required unscheduled visit)
Success was defined as rate of VTE recurrence ≤2.1% while on rivaroxaban, and a bleeding rate ≤9.4% while on rivaroxaban (goal rates obtained from EINSTEIN trial data).
Results: A total of 106 patients were discharged with low-risk VTE during the study period, including 71 with DVT only, 30 with PE only, and 5 with both DVT and PE. During the study period, this protocol captured 35/131 (27%) of all patients diagnosed with PE +/- DVT, and 71/140 (51%) of all patients diagnosed with DVT.
Investigators report that in these 106 patients, NONE developed recurrent VTE while on rivaroxaban, and NONE had a major bleeding event, meeting study criteria for success. However, 4 of 106 stopped taking rivaroxaban AMA, self-discharging themselves from the study early. Two of 106 died from end-stage diseases unrelated to VTE, and therefore did not complete rivaroxaban treatment. Three patients were completely lost to follow-up, yet were presumed to be negative for VTE recurrence or major bleeding event.
As of 6 months post enrollment of the last trial patient, 3 of 106 patients had VTE recurrence AFTER completion of rivaroxaban therapy.
The Takeaway: This study demonstrates that patients with DVT or PE that are at low risk for complication may be appropriate for immediate discharge and outpatient management with Xarelto. With no reported VTE recurrence or major bleeding event while on therapy, Xarelto may be a safe, more convenient alternative to the conventional outpatient treatment regimen of Lovenox and Warfarin. Limitations include lack of physical follow-up for 17 of 106 patients, including 3 presumed to be negative for VTE recurrence or major bleeding event despite complete lack of information via telephone or EMR. There is also a potential source of bias, as this study was funded in part by an award from Lilly.