HESTIA, Simplified PESI Comparable for Triage to Outpatient PE Treatment: HOME-PE

Many patients with acute pulmonary embolism (PE) can be treated safely at home when they are deemed to be low risk with the help of either the HESTIA criteria or simplified PESI score, results of the randomized HOME-PE trial show.

Use of the HESTIA criteria initially identified a lower proportion of patients who potentially would be eligible for home treatment, but those decisions were less likely to be overruled by treating physicians than those based on the simplified Pulmonary Embolism Severity Index (sPESI) score. Thus, the proportion of patients ultimately managed in the outpatient setting was similar in the HESTIA and sPESI arms of the trial (38.4% versus 36.6%).

Moreover, the triage strategy based on the HESTIA criteria was noninferior to the one based on the sPESI score in terms of the 30-day rate of recurrent venous thromboembolism, major bleeding, or death (3.8% vs  3.6%; P = 0.005 for noninferiority), Pierre-Marie Roy, MD, PhD (Angers University Hospital, France), reported during the virtual European Society of Cardiology (ESC) Congress 2020.

“In hospitals organized for outpatient management, with both triaging strategies, more than [one-third] of PE patients could be managed safely as outpatients, with low risk of adverse events,” he concluded.

Though several studies have now shown that it is safe and feasible to treat selected low-risk patients with PE at home, an idea embraced by international guidelines, there remains some uncertainty about how best to identify candidates for outpatient care, Roy noted. The HESTIA criteria are a series of questions that get at PE severity, comorbidities, and the feasibility of home treatment, whereas the sPESI score incorporates clinical parameters associated with PE severity and comorbidities to provide an estimate of 30-day mortality risk.

Treating more patients with acute PE in the outpatient setting—rather than hospitalizing everyone—is a shift that has occurred over the past several years, Robert Harrington, MD (Stanford University, CA), immediate past president of the American Heart Association, commented to TCTMD.

“This is a confirmation of the notion that we don’t have to [hospitalize everybody],” he said. “We can treat many of them with the appropriate care models as outpatients, which is great for patients, great for healthcare systems, and great for society with regard to costs.”

As for the utility of the two triage strategies evaluated, HOME-PE “says that if you deploy either of them the way that they’re intended, you can do a good job and identify a group of patients who can largely go home for their PE care,” Harrington said.

Care at Home

HOME-PE, conducted at 26 centers in France, Belgium, Switzerland, and the Netherlands, compared two triaging strategies based either on the HESTIA criteria or the sPESI score. All participating centers had a specific infrastructure set up to manage the outpatient care and follow-up of PE patients. The randomized trial included 1,974 normotensive patients who were enrolled in the emergency department within 24 hours of an acute PE diagnosis.

We can treat many of them with the appropriate care models as outpatients, which is great for patients, great for healthcare systems, and great for society with regard to costs. Robert Harrington

In each arm of the trial, the first step was allocation according to the chosen assessment tool. The proportion of patients determined to be at low risk and eligible for outpatient care instead of hospitalization was lower in the HESTIA versus sPESI arm (39.4% vs 48.4%).

In the next step, the physician in charge made the management decision. Among the patients initially deemed eligible for home treatment, physicians overruled that assessment less frequently in the HESTIA arm (3% vs 29%). So when it came to final management, the proportion of patients managed in the outpatient setting did not significantly differ between the two groups.

Through 30 days of follow-up, there were few adverse events—which included recurrent venous thromboembolism, major bleeding, and death—among the patients receiving treatment at home, with a rate of 1.3% in the HESTIA group and 1.1% in the sPESI group. One patient died in each group, and both had metastatic cancer and were receiving palliative care. No cases of recurrent or fatal PE were reported.

Systematic Approach Needed

Serving as a discussant after Roy’s presentation, Stavros Konstantinides, MD, PhD (Johannes Gutenberg University Mainz, Germany, and Democritus University of Thrace, Greece), asked who would be happy based on the results of the HOME-PE study.

Konstantinides said the writing group for the ESC’s updated acute PE guidance last year—which he chaired—are happy because the document states that low-risk PE patients can be identified using either the HESTIA criteria or the sPESI score. Moreover, he said, the trial confirms additional advice in the guideline—that “a low-risk patient can go home if there are no other reasons for hospitalization, there is family or social support, and there is easy access to medical care should anything happen, criteria which are integrated into HESTIA but which have to be [considered on top of the risk assessment] if one chooses the sPESI.”

Proponents of either assessment tool will be happy as well, Konstantinides said. “The HESTIA criteria are externally validated, so the HESTIA fans will be happy, and the sPESI fans will also not be unhappy because they found out what they already knew—namely, that their criteria needs to be added to social eligibility.”

It all depends on family support of the individual patients and on the infrastructure of the healthcare system in the particular country or region. Stavros Konstantinides

HOME-PE shows that about one-third of patients with acute PE can be treated in the outpatient setting, but with some caveats, Konstantinides concluded. “It all depends on family support of the individual patients and on the infrastructure of the healthcare system in the particular country or region,” he said, adding that any recommendation has to be adapted to the local situation. There are also remaining questions about whether additional imaging or laboratory criteria might be needed to exclude more-severe PE and enhance the safety of an early discharge strategy, particularly in centers that are not as experienced as those that participated in the trial.

For Harrington, the trial “really gets to this notion that you really need to have a systematic approach to the evaluation of these patients and the care of these patients, so that you’re asking all the appropriate questions” and not overlooking something that would support hospitalization.