Study supports early discharge, ambulatory rivaroxaban in low-risk pulmonary embolism

New data from the HoT-PE trial further support a strategy of early discharge and home oral anticoagulation with rivaroxaban in selected patients with low-risk pulmonary embolism.

Healio previously reported results of the HoT-PE trial.

“This report presents a comprehensive analysis of clinical outcomes and self-reported quality of life in the entire population of the HoT-PE study. ... The results of the predefined interim analysis yielded low rates of the primary outcome, ie, symptomatic recurrent venous thromboembolism or pulmonary embolism-related death, at the 3-month follow-up and thus allowed for early termination of the trial. The present analysis focuses on long-term survival as well as quality of life and its change over time following early discharge of patients with acute low-risk pulmonary embolism,” Stefano Barco, MD, PhD, research group leader at the Center for Thrombosis and Hemostasis at the University Medical Center Mainz, Germany, and staff physician in the Clinic of Angiology at the University Hospital Zurich, and colleagues wrote in the European Respiratory Journal.

The prospective, multinational, investigator-initiated, single-arm, phase 4 HoT-PE trial included adults with low-risk PE (mean age, 57 years; 46.2% women) enrolled from May 2014 to June 2018. Patients received the first dose of the study medication, rivaroxaban (Xarelto, Janseen/Bayer) 15 mg twice daily for 3 weeks, within 2 hours of the next due dose of low-molecular-weight heparin or fondaparinux or at the time of IV unfractionated heparin discontinuation. Rivaroxaban was given for a mean of 21 days after diagnosis, and patients received the maintenance dose of 20 mg for a mean of 69 days.

The trial was stopped for efficacy after the positive results of the predefined interim analysis at 50% of the planned study population.

The present analysis includes results from the entire population of 576 patients. In addition to the 3-month recurrence of symptomatic VTE or fatal PE, the researchers also evaluated self-reported disease-specific and generic quality of life using the Pulmonary Embolism Quality of Life questionnaire and the EuroQoL scale. Treatment satisfaction with rivaroxaban (Xarelto, Janssen/Bayer) was also assessed using the Anti-Clot Treatment Scale.

Symptomatic recurrent VTE or PE-related death within 3 months occurred in 0.5% of patients. The 1-year mortality rate was 2.4%.

Mean Pulmonary Embolism Quality of Life questionnaire score decreased from 28.9% at 3 weeks to 19.9% at 3 months, with a mean improvement of –9.1 percentage points (P < .0001). The improvements were consistent across all dimensions of the questionnaire. Generic quality of life using the EuroQOL scale improved from 0.89 at 3 weeks to 0.91 at 3 months (P < .0001), according to the results.

Female sex and cardiopulmonary disease were associated with poorer quality of life at 3 weeks and 3 months, and older age was associated with rapid worsening of generic quality of life, according to the results.

Among 421 patients who completed the Anti-Clot Treatment Scale questionnaire at 3 weeks and 3 months, the mean burden score improved from 40.5 points at 3 weeks to 42.5 points at 3 months (P < .0001).

“Anticoagulation with rivaroxaban initiated in the hospital and continued over at least 3 months was effective and safe. All-cause mortality was extremely low over the entire 12-month follow-up period. The patients’ quality of life improved early during follow-up as assessed on the basis of standardized, disease-specific and generic quality of life questionnaires. Future early-discharge strategies may need to target individuals with specific baseline characteristics such as female sex, an increased body mass index and a history of cardiac or pulmonary disease,” the researchers wrote.