August 31, 2020
HOME-PE Trial Clarifies Which Acute PE Patients Can Be Managed at Home
August 31, 2020—Patients with acute pulmonary embolism (PE) can be selected for home management using either the criteria recommended by European guidelines or those recommended by American guidelines, according to results of the HOME-PE trial, announced by the European Society of Cardiology (ESC). The study’s findings were presented in a Hot Line session at ESC Congress 2020—The Digital Experience, held online as a virtual event August 29 to September 1, 2020.
According to ESC, European guidelines recommend the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI) to assess the risk of all-cause mortality. By these criteria, patients with an sPESI score of 0 can be treated at home, providing that proper follow-up and anticoagulant therapy can be provided. By contrast, American guidelines do not require a predefined score and advise using pragmatic criteria such as those in the Hestia Study.
Historically, hospitalization was justified because of the risks of recurrence and bleeding; but in the last decade, several studies have demonstrated the possibility of home treatment for selected hemodynamically stable patients. Controversy persists about the optimal referral strategies and eligibility criteria for outpatient care, advised ESC.
The HOME-PE trial examined whether a strategy based on the Hestia criteria was at least as safe as a strategy based on the sPESI score to select patients for home treatment. In addition, it evaluated whether the Hestia method was more efficient compared to the sPESI score—in other words, whether it led to more patients being selected for home treatment. HOME-PE was a randomized, open-label, noninferiority trial comparing the two triaging strategies. It was conducted in 26 hospitals in France, Belgium, the Netherlands, and Switzerland. Before initiation of the study, each hospital set up a thrombosis team for outpatient care of patients with acute PE.
The study included 1,974 patients with normal blood pressure presenting to the emergency department with acute PE in 2017 to 2019. Patients randomized to the sPESI group were eligible for outpatient care if the score was 0; otherwise, they were hospitalized. Patients randomized to the Hestia group were eligible for outpatient care if all 11 criteria were negative; otherwise, they were hospitalized. In both groups, the physician in charge could overrule the decision on treatment location for medical or social reasons.
The primary outcome was a composite of recurrent venous thromboembolism, major bleeding, and all-cause death within 30 days.
The Hestia strategy was noninferior to the sPESI strategy; the primary outcome occurred in 3.8% of the Hestia group and 3.6% of the sPESI group (P = .005).
A greater proportion of patients were eligible for home care using sPESI (48.4%) compared with Hestia (39.4%). However, the doctor in charge of the patient overruled sPESI more often than Hestia. Consequently, a similar proportion of patients were discharged within 24 hours for home treatment: 38.4% in the Hestia group and 36.6% in the sPESI group (P = .42). All patients managed at home had a low rate of complications.
“The pragmatic Hestia method was at least as safe as the sPESI score for triaging hemodynamically stable PE patients for outpatient care,” commented Principal Investigator Professor Pierre-Marie Roy, MD, of the University Hospital of Angers, France, in the ESC press release.
Prof. Roy continued, “These results support outpatient management of acute PE patients using either the Hestia method or the sPESI score with the option for physicians to override the decision. In hospitals organized for outpatient management, both triaging strategies enable more than a third of PE patients to be managed at home with a low rate of complications.”