PE is the third most frequent acute cardiovascular syndrome after myocardial infarction and cerebrovascular accidents.¹ In fact, PE results in 60,000-100,000 deaths per year in the United States.² PE is also associated with substantial health care resource utilization because many low-risk patients not requiring acute inpatient care are ultimately hospitalized. In a retrospective cohort analysis of patients admitted with PE, mean total hospitalization cost per patient was $11,486.³ It has also been postulated that if low-risk patients were effectively managed on an ambulatory basis, US health care costs could be lowered by $1 billion per year.⁴ A need exists to effectively screen and identify low-risk patients who are potentially eligible for ambulatory management of PE.

Patients with PE at low risk for complications are hemodynamically stable and can be effectively managed by anticoagulation alone.⁵ Therefore, different triaging scores have been developed to identify these low-risk patients who are potentially eligible for ambulatory management. The Pulmonary Embolism Severity Index is a validated prognostication score the comprises 11 clinical parameters.^6,7 A simplified version of this score (sPESI) includes 6 variables and has been shown to have similar prognostic value.⁸ Another risk-stratification score, the HESTIA rule, comprises parameters that preclude eligibility for ambulatory management, such as lack of social support at home.⁹ Table 1 displays a comparison of the 2 scores.

Table 1: Clinical Determinants in HESTIA and sPESI Criteria

HESTIA	sPESI
Hemodynamic instability Thrombolysis or embolectomy indicated Active bleeding or high risk of bleeding Need for supplemental oxygen PE diagnosed during anticoagulant treatment Severe pain requiring intravenous medications Medical or social reason for in-hospital treatment Severe renal or liver impairment Pregnancy	Age >80 years History of cancer Chronic cardiopulmonary disease Systolic blood pressure <100 mmHg Heart rate >110 bpm Arterial oxygen saturation <90%
If a patient exhibits one or more of these criteria, the patient is not eligible for ambulatory management.	One point is given for the presence of each one of these factors. Patients with a score of 0 are considered low risk and eligible for ambulatory management.

The HOME-PE study, led by Dr. Pierre-Marie Roy (University Hospital of Angers, France), compared the performance of the sPESI and HESTIA criteria; the results were presented at the virtual European Society of Cardiology Congress 2020.¹⁰ The HOME-PE study was a multicenter, open-label, non-inferiority trial that examined whether a strategy based on the HESTIA criteria was at least as safe as a strategy based on the sPESI criteria to select patients for ambulatory management of PE. A total of 1,974 patients underwent randomization between 2017 and 2019 at 26 hospitals in Belgium, France, the Netherlands, and Switzerland. Patients were randomized to either a HESTIA rule approach (n = 984) or an sPESI triage group (n = 986). Patients in the sPESI arm were candidates for outpatient management if their score was 0. Patients randomized to the HESTIA arm were candidates for outpatient management if all HESTIA criteria were negative. For both study arms, the physician in charge could overrule the allocation strategy based on clinical judgment.

The primary outcome was a composite of all-cause mortality, recurrent VTE, and major bleed at 30 days. Secondary outcomes included a comparison of efficiency (defined as the actual rate of patients treated in the outpatient setting in the intention-to-treat population), efficacy (defined as the rate of patients eligible for ambulatory management in the per-protocol population), and applicability (defined as the rate of patients treated in the outpatient setting among patients deemed eligible for ambulatory management).

There were no major differences in baseline characteristics between both arms. The mean age of participants was 63.5 ± 17.7 years and 62.3 ±17.5 years in the HESTIA and sPESI groups, respectively, and 51.7% and 52% were male. Of interest, there was evidence of right ventricular overload in 22.4% and 27.3% of patients in the HESTIA and sPESI arms, respectively. Most patients were treated with direct oral anticoagulants (72.6% in HESTIA and 74.1% in sPESI). Results of the allocation strategy showed that 39.4% of patients in the HESTIA arm and 48.4% of patients in the sPESI arm were eligible for ambulatory management. However, after application of clinical judgement by the treating physician, 3% of patients deemed eligible for ambulatory care by the HESTIA rule and 29% of patients deemed eligible for ambulatory care by the sPESI score were hospitalized. The primary safety outcome in the per-protocol population was 3.82% and 3.57% in the HESTIA and sPESI arms, respectively (non-inferiority p = 0.005), demonstrating non-inferiority of HESTIA compared to sPESI for the composite rate of recurrent VTE, death, and major bleed at 30 days.

Regarding the secondary endpoints, there was no significant difference between HESTIA and sPESI on the rate of patients treated at home (38.4% and 36.6%, respectively; p = 0.41). However, efficacy of the rule (rate of low-risk patients eligible for outpatient care per rule) was lower in HESTIA than sPESI (39.4% compared to 48.4%, respectively; adjusted absolute difference -8.91%; 90% confidence interval, -13.3 to -4.56), whereas applicability (rate of patients actually treated at home among eligible patients) was higher for HESTIA than sPESI (88.4% compared to 64.8%; adjusted absolute difference 25.3%; 90% confidence interval, 19.5 to 31.1). The rate of adverse clinical outcomes was low in both groups.

Dr. Roy and collaborators compared the performance of two risk-stratification scores among hemodynamically stable patients with PE to triage eligible patients for ambulatory management. The study shows that an approach based on the HESTIA rule was non-inferior to sPESI with respect to the composite endpoint of death, recurrent VTE, or major bleed at 30 days. The study also showed that up to a third of patients can be effectively managed in an ambulatory setting with a low rate of complications. The results emphasize further what has already been shown in prior studies, which is that both criteria have similar risk classification determination and prognostic accuracy.¹¹ The study also showed that, although the HESTIA rule identified a lower number of patients eligible for ambulatory management, HESTIA had better applicability because fewer patients were overruled by the physician in charge (3%) compared with sPESI (29%). These results are similar to a prior study in which 770 of 1557 patients were deemed eligible for outpatient therapy (using PESI criteria), but almost 35% of them did not receive ambulatory management, mainly due to social barriers for a successful therapy based on the physician's assessment.⁷

In summary, the HOME-PE study showed that the HESTIA rule and sPESI risk-stratification models are comparable in identifying low-risk patients with PE who can then be safely managed at home. Up to a third of patients with hemodynamically stable PE may be eligible for ambulatory management of PE, with the potential benefit of reducing health care system costs and prevention of complications such as hospital-acquired infections. This study will pave the way toward changing current practice trends in management of low-risk patients with PE. As described in the study, it is also important to remember that these scoring strategies are clinical aids and should not replace clinical judgement.

References

1. Raskob GE, Angchaisuksiri P, Blanco AN, et al. Thrombosis: a major contributor to global disease burden. Arterioscler Thromb Vasc Biol 2014;34:2363-71.
2. Benjamin EJ, Muntner P, Alonso A, et al. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation 2019;139:e56-e528.
3. Dasta JF, Pilon D, Mody SH, et al. Daily hospitalization costs in patients with deep vein thrombosis or pulmonary embolism treated with anticoagulant therapy. Thromb Res 2015;135:303-10.
4. Dalen JE, Dalen JE Jr. Unnecessary Hospitalizations for Pulmonary Embolism: Impact on US Health Care Costs. Am J Med 2016;129:899-900.
5. Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS): The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC). Eur Respir J 2019;54:1901647.
6. Aujesky D, Obrosky DS, Stone RA, et al. Derivation and validation of a prognostic model for pulmonary embolism. Am J Respir Crit Care Med 2005;172:1041-6.
7. Aujesky D, Roy PM, Verschuren F, et al. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet 2011;378:41-8.
8. Jiménez D, Aujesky D, Moores L, et al. Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism. Arch Intern Med 2010;170:1383-9.
9. Zondag W, Mos ICM, Creemers-Schild D, et al. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost 2011;9:1500-7.
10. Hot Line: Hospitalisation or Outpatient Management of patients with acute Pulmonary Embolism – results from the HOME-PE trial (ESCardio.org). August 10, 2020. Available at https://www.escardio.org/Congresses-&-Events/ESC-Congress/Congress-resources/Congress-news/hot-line-hospitalisation-or-outpatient-management-of-patients-with-acute-pulmonary-embolism-results-from-the-home-pe-trial. Accessed September 21, 2020.
11. Quezada CA, Bikdeli B, Villén T, et al. Accuracy and Interobserver Reliability of the Simplified Pulmonary Embolism Severity Index Versus the Hestia Criteria for Patients With Pulmonary Embolism. Acad Emerg Med 2019;26:394-401.

Clinical Topics: Anticoagulation Management, Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Pulmonary Hypertension, Interventions and Vascular Medicine, Hypertension

Keywords: Hypertension, Pulmonary, Hypertension, Anticoagulants, Retrospective Studies, Pregnancy, Prognosis, Outpatients, Triage, Blood Pressure, Heart Rate, Confidence Intervals, Oxygen, Inpatients, Intention to Treat Analysis, Random Allocation, Pulmonary Embolism, Ambulatory Care, Hospitalization, Embolectomy, Neoplasms, Myocardial Infarction, Health Care Costs, Stroke, Delivery of Health Care, Risk Assessment, Thrombolytic Therapy

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