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Example
Contribution To Literature:
The HOME-PE trial showed that risk stratification can identify approximately one-third of PE patients who can be safely treated at home.
Description:
The goal of the trial was to evaluate two risk stratification tools among patients diagnosed with pulmonary embolism (PE).
Study Design
- Randomized
- Parallel
- Open-label
Eligible patients were randomized to risk stratification with the HESTIA rule (n = 984) versus the simplified Pulmonary Embolism Severity Index (PESI) score (n = 986). Low-risk patients were discharged home, while > low-risk patients were admitted to the hospital.
The HESTIA rule is considered low-risk if none of the following apply: hemodynamic instability, thrombolysis or embolectomy, active bleeding or high-risk of bleeding, supplemental oxygen, PE diagnosed during anticoagulation treatment, severe pain requiring intravenous medication, medical or social reason for hospitalization, severe renal or hepatic impairment, or pregnancy.
The PESI score assigns a score for each of the following: age >80 years, history of cancer, chronic cardiopulmonary disease, systolic blood pressure <100 mm Hg, heart rate ≥110 beats per minute, or oxygen saturation <90%. Low risk is considered a score of 0.
- Total number of enrollees: 1,970
- Duration of follow-up: 90 days
- Mean patient age: 64 years
- Percentage female:
- Total number of enrollees: 1,970
- Duration of follow-up: 90 days
- Mean patient age: 64 years
- Percentage female: 48%
Inclusion criteria:
- Patients diagnosed with PE
Other salient features/characteristics:
- In the HESTIA group, 62% were hospitalized, while 38% were managed at home.
- In the PESI group, 64% were hospitalized, while 36% were managed at home.
Principal Findings:
The primary outcome, all-cause death, recurrent VTE, or major bleeding at 30 days, occurred in 3.8% of the HESTIA group compared with 3.6% of the PESI group (p for noninferiority = 0.005).
Secondary outcomes:
- Proportion of patients actually treated as outpatients: 38.4% of the HESTIA group compared with 36.6% of the PESI group (p for superiority = 0.41)
- Rate of low-risk patients eligible for outpatient care: 39.4% of the HESTIA group compared with 48.4% of the PESI group
- Patients treated as outpatients among eligible patients: 88.4% of the HESTIA group compared with 64.8% of the PESI group
Interpretation:
Among patients with PE, risk stratification with the HESTIA rule was noninferior to the PESI score on all-cause death, recurrent VTE, or major bleeding. The two strategies were similar regarding the proportion of patients treated at home. By using risk stratification, approximately one-third of low-risk patients with PE could be safely managed at home.
References:
Presented by Dr. Pierre-Marie Roy at the European Society of Cardiology Virtual Congress, August 31, 2020.
Clinical Topics: Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Prevention, Pulmonary Hypertension and Venous Thromboembolism, Vascular Medicine, Anticoagulation Management and Venothromboembolism, Interventions and Vascular Medicine
Keywords: ESC Congress, ESC20, Anticoagulants, Blood Pressure, Embolectomy, Hemorrhage, Neoplasms, Outpatients, Patient Discharge, Pulmonary Embolism, Primary Prevention, Risk Assessment, Thrombolytic Therapy, Thromboembolism, Vascular Diseases, Venous Thromboembolism
< Back to Listings<div class="reading-typography">
<div class="the-text">
<div class="contribution-to-literature">
<h2>Contribution To Literature:</h2>
<p></p>
<p>The HOME-PE trial showed that risk stratification can identify approximately one-third of PE patients who can be safely treated at home.</p>
<p></p>
</div>
<div class="description">
<h2>Description:</h2>
<p></p>
<p>The goal of the trial was to evaluate two risk stratification tools among patients diagnosed with pulmonary embolism (PE).</p>
<p></p>
</div>
<div class="study-design">
<h2>Study Design</h2>
<p></p>
<ul>
<li>Randomized</li>
<li>Parallel</li>
<li>Open-label</li>
</ul>
<p>Eligible patients were randomized to risk stratification with the HESTIA rule (n = 984) versus the simplified Pulmonary Embolism Severity Index (PESI) score (n = 986). Low-risk patients were discharged home, while > low-risk patients were admitted to the hospital.</p>
<p>The HESTIA rule is considered low-risk if none of the following apply: hemodynamic instability, thrombolysis or embolectomy, active bleeding or high-risk of bleeding, supplemental oxygen, PE diagnosed during anticoagulation treatment, severe pain requiring intravenous medication, medical or social reason for hospitalization, severe renal or hepatic impairment, or pregnancy.</p>
<p>The PESI score assigns a score for each of the following: age >80 years, history of cancer, chronic cardiopulmonary disease, systolic blood pressure <100 mm Hg, heart rate ≥110 beats per minute, or oxygen saturation <90%. Low risk is considered a score of 0. </p>
<ul>
<li>Total number of enrollees: 1,970</li>
<li>Duration of follow-up: 90 days</li>
<li>Mean patient age: 64 years</li>
<li>Percentage female:
<ul>
<li>Total number of enrollees: 1,970</li>
<li>Duration of follow-up: 90 days</li>
<li>Mean patient age: 64 years</li>
<li>Percentage female: 48%</li>
</ul></li>
</ul>
<p>Inclusion criteria:</p>
<ul>
<li>Patients diagnosed with PE</li>
</ul>
<p>Other salient features/characteristics: </p>
<ul>
<li>In the HESTIA group, 62% were hospitalized, while 38% were managed at home.</li>
<li>In the PESI group, 64% were hospitalized, while 36% were managed at home.</li>
</ul>
<p></p>
</div>
<div class="principal-findings">
<h2>Principal Findings:</h2>
<p></p>
<p>The primary outcome, all-cause death, recurrent VTE, or major bleeding at 30 days, occurred in 3.8% of the HESTIA group compared with 3.6% of the PESI group (p for noninferiority = 0.005). </p>
<p>Secondary outcomes:</p>
<ul>
<li>Proportion of patients actually treated as outpatients: 38.4% of the HESTIA group compared with 36.6% of the PESI group (p for superiority = 0.41)</li>
<li>Rate of low-risk patients eligible for outpatient care: 39.4% of the HESTIA group compared with 48.4% of the PESI group</li>
<li>Patients treated as outpatients among eligible patients: 88.4% of the HESTIA group compared with 64.8% of the PESI group</li>
</ul>
<p></p>
</div>
<div class="interpretation">
<h2>Interpretation:</h2>
<p>Among patients with PE, risk stratification with the HESTIA rule was noninferior to the PESI score on all-cause death, recurrent VTE, or major bleeding. The two strategies were similar regarding the proportion of patients treated at home. By using risk stratification, approximately one-third of low-risk patients with PE could be safely managed at home.<br></p>
</div>
<div class="legacy-references" id="references-for-article">
<h2>References:</h2>
<p></p>
<p>Presented by Dr. Pierre-Marie Roy at the European Society of Cardiology Virtual Congress, August 31, 2020.</p>
<p></p>
</div>
<p class="topics-list"><b>Clinical Topics:</b> <a href="http://www.acc.org/clinical-topics/anticoagulation-management">Anticoagulation Management, </a><a href="http://www.acc.org/clinical-topics/invasive-cardiovascular-angiography-and-intervention">Invasive Cardiovascular Angiography and Intervention, </a><a href="http://www.acc.org/clinical-topics/prevention">Prevention, </a><a href="http://www.acc.org/clinical-topics/pulmonary-hypertension-and-venous-thromboembolism">Pulmonary Hypertension and Venous Thromboembolism, </a><a href="http://www.acc.org/clinical-topics/vascular-medicine">Vascular Medicine, </a><a href="http://www.acc.org/clinical-topics/anticoagulation-management/anticoagulation-management-and-venothromboembolism">Anticoagulation Management and Venothromboembolism, </a><a href="http://www.acc.org/clinical-topics/invasive-cardiovascular-angiography-and-intervention/interventions-and-vascular-medicine">Interventions and Vascular Medicine</a> </p>
<p class="keywords-list"><b>Keywords:</b> <i>ESC Congress, </i><i>ESC20, </i><i>Anticoagulants, </i><i>Blood Pressure, </i><i>Embolectomy, </i><i>Hemorrhage, </i><i>Neoplasms, </i><i>Outpatients, </i><i>Patient Discharge, </i><i>Pulmonary Embolism, </i><i>Primary Prevention, </i><i>Risk Assessment, </i><i>Thrombolytic Therapy, </i><i>Thromboembolism, </i><i>Vascular Diseases, </i><i>Venous Thromboembolism</i> </p>
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