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Dr. F.A. (Erik) Klok ,
Barco S et al. Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multicentre single-arm clinical trial. Eur Heart J. 2019 May 23.
Several studies have shown the feasibility of treating patients with acute pulmonary embolism (PE) at home. In such studies, patients were selected for home treatment or early discharge based on either the Pulmonary Embolism Severity Index (PESI) combined with a list of practical considerations, or the HESTIA criteria. The larger published studies on this topic were performed before the introduction of the DOACs, the latter which should further decrease the threshold for withholding hospital admission. Formal evaluation of home treatment with DOACs however was not available until the recent publication of the home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban (HoT-PE Trial).
The HoT-PE Trial was a prospective multicentre single-arm investigator-initiated Phase 4 interventional trial, in which patients with symptomatic acute PE were treated at home if they did not meet any of the HESTIA criteria and had no evidence of right ventricular enlargement of dysfunction as measured by CT or echocardiography. After inclusion, they were treated with rivaroxaban and discharged from the hospital within 48 hours. The trial was terminated early after the planned interim analysis. At that point 525 patients had been included; 12% was discharged directly from the emergency room, 42% after hospitalisation for 1 night and 44% after hospital stay for 2 nights; 2.1% of patients required a prolonged hospital stay due to a serious adverse event. The primary efficacy outcome of symptomatic recurrent venous thromboembolism or PE-related death occurred in 0.6% of patients in the 3-month follow-up period, and 1.2% had a major bleeding. Because the term home treatment is mostly reserved for patients discharged within 24 hours, the final conclusion of the authors was that “early discharge with continuation of anticoagulant treatment at home was effective and safe in carefully selected patients with acute PE”.
The HoT-PE trial confirms that home treatment or early discharge of PE with a DOAC based on the HESTIA criteria is safe and feasible. Further, it has evaluated for the first time a strategy that involved a decision rule with baseline assessment of right ventricular function as criterion for home treatment, allowing physicians now to choose from one additional strategy to decide whether hospitalisation of their PE patients is required or not: PESI with practical considerations, HESTIA or HESTIA with right ventricular function assessment. The optimal strategy will mostly depend on local circumstances, taking case mix, local regulations and healthcare system, social infrastructure and physician/patient preferences into account. The ongoing randomized controlled HOME study, comparing simplified PESI and HESTIA without explicit evacuation of cardiac function, will hopefully provide more insight on this point.
Eur Heart J. 2019 May 23. pii: ehz367. doi: 10.1093/eurheartj/ehz367
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