Outpatient management of cancer-associated pulmonary embolism: A post-hoc analysis from the HOME-PE trial.

INTRODUCTION: Cancer-related pulmonary embolism (PE) is associated with poor prognosis. Some decision rules identifying patients eligible for home treatment categorize cancer patients at high risk of complications, precluding home treatment. We sought to assess the effectiveness and the safety of outpatient management of patients with low-risk cancer-associated PE. METHODS: In the HOME-PE trial, hemodynamically stable patients with symptomatic PE were randomized to either triaging with Hestia criteria or sPESI score. We analyzed 3 groups of low-risk PE patients: 47 with active cancer treated at home (group 1), 691 without active cancer treated at home (group 2), and 33 with active cancer as the only sPESI criterion qualifying them for hospitalization (group 3). The main outcome was the composite of recurrent venous thromboembolism, major bleeding, and all-cause death within 30 days after randomization. RESULTS: Patients treated at home had composite outcome rates of 4.3 % (2/47) for those with cancer vs. 1.0 % (7/691) for those without (odds ratio (OR) 4.98, 95%CI 1.15-21.49). Patients with cancer had rates of complications of 4.3 % when treated at home vs. 3.0 % (1/33) when hospitalized (OR 1.19, 95%CI 0.15-9.47). In multivariable analysis, active cancer was associated with an increased risk of complications for patients treated at home (OR 7.95; 95%CI 1.48-42.82). For patients with active cancer, home treatment was not associated with the primary outcome (OR 1.19, 95%CI 0.15-9.74). CONCLUSIONS: Among patients treated at home, active cancer was a risk factor for complications, but among patients with active cancer, home treatment was not associated with adverse outcomes.

Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial.

AIMS: The aim of this study is to compare the Hestia rule vs. the simplified Pulmonary Embolism Severity Index (sPESI) for triaging patients with acute pulmonary embolism (PE) for home treatment. METHODS AND RESULTS: Normotensive patients with PE of 26 hospitals from France, Belgium, the Netherlands, and Switzerland were randomized to either triaging with Hestia or sPESI. They were designated for home treatment if the triaging tool was negative and if the physician-in-charge, taking into account the patient's opinion, did not consider that hospitalization was required. The main outcomes were the 30-day composite of recurrent venous thrombo-embolism, major bleeding or all-cause death (non-inferiority analysis with 2.5% absolute risk difference as margin), and the rate of patients discharged home within 24 h after randomization (NCT02811237). From January 2017 through July 2019, 1975 patients were included. In the per-protocol population, the primary outcome occurred in 3.82% (34/891) in the Hestia arm and 3.57% (32/896) in the sPESI arm (P = 0.004 for non-inferiority). In the intention-to-treat population, 38.4% of the Hestia patients (378/984) were treated at home vs. 36.6% (361/986) of the sPESI patients (P = 0.41 for superiority), with a 30-day composite outcome rate of 1.33% (5/375) and 1.11% (4/359), respectively. No recurrent or fatal PE occurred in either home treatment arm. CONCLUSIONS: For triaging PE patients, the strategy based on the Hestia rule and the strategy based on sPESI had similar safety and effectiveness. With either tool complemented by the overruling of the physician-in-charge, more than a third of patients were treated at home with a low incidence of complications.

Predictive value of the heart-type fatty acid-binding protein and the Pulmonary Embolism Severity Index in patients with acute pulmonary embolism in the emergency department.

OBJECTIVES: Heart-type fatty acid-binding protein (h-FABP), sensitive troponins, natriuretic peptides, and clinical scores such as the Pulmonary Embolism Severity Index (PESI) are candidates for risk stratification of patients with acute pulmonary embolism (PE). The aim was to compare their respective prognostic values to predict an adverse outcome at 1 month. METHODS: The authors prospectively included 132 consecutive patients with confirmed acute PE. On admission to the emergency department (ED), plasma concentrations of h-FABP, sensitive cardiac troponin I-Ultra (cTnI-Ultra), and brain natriuretic peptide (BNP) were measured and the PESI calculated in all patients. The combined 30-day outcomes of interest were death, cardiac arrest, mechanical ventilation, use of catecholamines, and recurrence of acute PE. RESULTS: During the first 30 days, 14 (10.6%) patients suffered complications. Among the biomarkers, h-FABP above 6 µg/L was a stronger predictor of an unfavorable outcome (odds ratio [OR] = 17.5, 95% confidence interval [CI] = 4.2 to 73.3) than BNP > 100 pg/mL (OR = 5.7, 95% CI = 1.6 to 20.4) or cTnI-Ultra > 0.05 µg/L (OR = 3.4, 95% CI = 1.1 to 10.9). The PESI classified 83 of 118 patients (70.3%) with favorable outcomes and only one of 14 (7%) with adverse outcomes in low class I or II (OR = 30.8, 95% CI = 3.2 to 299.7). The areas under the receiver operating characteristic (ROC) curves (AUCs) were 0.90 (95% CI = 0.81 to 0.98) for h-FABP, 0.89 (95% CI = 0.82 to 0.96) for PESI, 0.79 (95% CI = 0.67 to 0.90) for BNP, and 0.76 (95% CI = 0.64 to 0.87) for cTnI-Ultra. The combination of h-FABP with PESI was a particularly useful prognostic indicator because none of the 79 patients (59.8%) with h-FABP < 6 ng/mL and PESI class < III had an adverse outcome. CONCLUSIONS: h-FABP and the PESI are superior to BNP and cTnI-Ultra as markers for risk stratification of patients with acute PE. The high sensitivity of their combination identified a large number of low-risk patients in the ED.