ORLANDO, Fla.—Patients with pulmonary embolism (PE) are initially treated in the hospital with low molecular weight heparin (LMWH). Using Hestia criteria, however, they may be selected and safely treated as outpatients, results of a clinical study have found.
The study addressed a need for reliable, easy-to-use selection criteria to determine which patients with PE may be eligible for outpatient treatment, noted Wendy Zondag, MD, of Leiden University Medical Centre, Leiden, The Netherlands. While the American College of Chest Physicians most recent guideline on antithrombotic therapy notes that some small studies have suggested outpatient treatment in patients with PE is potentially safe and effective, firm clinical recommendations are lacking, Dr. Zondag and colleagues reported in a late-breaking abstract session held during the 52nd American Society of Hematology Annual Meeting and Exposition.
In the open-label, single-arm, multicenter trial conducted in 12 hospitals in the Netherlands, patients with acute PE were triaged using the predefined Hestia criteria, which comprise 11 questions regarding status of a patient with PE, including risk, comorbidities, and whether hospitalization is otherwise indicated. Please click here for more study data. If any 1 of the 11 questions was answered, “Yes,” the patient could not be treated at home.
Inclusion criteria included patients with objectively proven PE, ≥18 years of age, and with acute symptomatic PE presenting as an outpatient; 3-month follow-up was needed in addition to written informed consent. Those eligible for outpatient treatment were sent home, either immediately or within 24 hours after an objective diagnosis of PE.
Treatment was initiated using weight-adjusted doses of LMWH followed by vitamin K antagonists.
Outpatients were evaluated with respect to recurrent venous thromboembolism (VTE), including PE or deep venous thrombosis (DVT), major hemorrhage and total mortality, both during initial treatment with LMWH and at 3-month follow-up. Outpatient treatment was considered to be effective if the upper limit of the 95% confidence interval of the incidence of recurrent VTE did not exceed 7%.
Of the 297 (51%) outpatients, all of whom had completed follow-up, 6 (2%; 95% CI, 0.8-4.3) had recurrent VTE, 5 PE (1.7%) and 1 DVT (0.3 %). Three patients (1%, 95% CI, 0.2-2.9) died during the 3-month follow-up period, but none as a result of fatal PE; 1 died of fatal intracerebral hemorrhage and the other 2 of progressive malignancy. In addition to the patient with intracranial bleeding, 2 other patients had a major bleeding event.
Outpatient treatment of patients with acute PE selected by the Hestia criteria was found to be effective and safe. “A regimen that can be administered completely in the outpatient setting should have major economic benefits and might also impact patient quality of life,” stated Dr Zondag. Study results showed a low 3-month nonfatal VTE recurrence rate of 2% and a low major bleed rate (0.7%; 95% CI, 0.26-2.7%).