Study . | Primary study aim . | Study period . | Selection of low-risk patients . | Follow-up (days) . | Outcome adjudication . | PE patients treated at home according to the study definition of home treatment, n (% of total study population) . | PE patients treated at home according to the IPDMA definition of home treatment, n (% of previous column) . |
---|---|---|---|---|---|---|---|
Barco et al.25 (HoT-PE) | Evaluate the efficacy and safety of home treatment in low-risk acute PE patient treated with rivaroxaban | May 2014–June 2018 | Negative Hestia rule and no RV dysfunction or intra-cardiac thrombi | 90 | Yes | 520 (100)a | 170 (32)i |
Bledsoe et al.3 | Evaluate the efficacy and safety outpatient treatment in low-risk acute PE patients | January 2013–October 2016 | PESI Class I or II with a list of exclusion criteria including RV dysfunction on echocardiography | 90 | No | 200 (100)b | 192 (96)i |
den Exter et al.28 (Vesta) | Evaluate the utility and safety of the Hestia rule vs. Hestia rule in combination with (NT-pro)BNP testing for selection of outpatient PE treatment | December 2010–February 2014 | Negative Hestia rule with/without negative (NT-pro)BNP testing | 90 | Yes | 513 (93)c | 513 (100)j |
Font et al.27 | Evaluate the feasibility of outpatient treatment in patients with cancer and PE | May 2006–December 2009 | Negative Hestia-like criteria: systolic blood pressure < 100 mmHg, arterial oxygen pressure < 60 mmHg or pulse oximetry < 90%, active bleeding, platelet count ≥50 000/mm3, renal failure, lack of social support, poor treatment compliance, or the presence of other admission criteria according to treating physicians | 90 | Yes | 62 (45)d | 62 (100)d |
Kabrhel et al.29 | Determine whether a protocol combining risk stratification, treatment with rivaroxaban, and defined follow-up is associated with a greater proportion of patients with VTE treated as outpatients | September 2015–unknown | Negative: social or psychological barrier, abnormal vital signs, coronary artery disease or congestive heart failure, elevated troponin, high risk of bleeding, large PE, intermediate PE with RV dysfunction, high-risk DVT | 28 | No | 164 (25)e | 122 (74)k |
Kline et al.30 (MATH-VTE) | Evaluate the safety and efficacy of home treatment with a DOAC in low-risk acute PE patient presented at the emergency department | April 2016–March 2019 | Negative modified Hestia rule or sPESI of 0 plus physician’s judgement | 30 | No | 604 (100)f | 604 (100)f |
Otero et al.26 | Evaluate efficacy and safety of early discharge in patients with low risk according to a clinical prediction rule | February 2005–April 2007 | ≤2 points on a clinical prediction score, haemodynamic instability, troponin ≥ 0.1 ng/mL, saturation < 93%, need for hospitalization for comorbidities, severe chronic obstructive pulmonary disease, severe asthma, active or high risk of bleeding, pregnancy, morbid obesity, or RV dysfunction | 30 | No | 72 (55)g | 0 (0)j |
Roy et al.11 (HOME-PE) | Evaluate safety and efficacy of Hestia vs. sPESI in the selection of outpatient PE treatment | January 2017–July 2019 | Negative Hestia rule or sPESI of 0 (overruling by clinician possible) | 30 | Yes | 739 (38)h | 681 (92)k |
Vinson et al.31 (eSPEED) | Evaluate the effect of an integrated electronic clinical decision support system to facilitate risk stratification and decision for selection of outpatient PE treatment | January 2014–April 2015 | PESI Class I or II with a broad list of relative contraindications from variables from the Ottawa and Hestia exclusion criteria (including absence of RV dysfunction) | 30 | No | 130 (19)c | 116 (89)k |
Zondag et al.9,10 (Hestia) | Evaluate the efficacy and safety of outpatient treatment according to the Hestia rule in patients with acute PE | May 2008–April 2010 | Negative Hestia rule | 90 | Yes | 297 (100)c | 296 (100)j |
Study . | Primary study aim . | Study period . | Selection of low-risk patients . | Follow-up (days) . | Outcome adjudication . | PE patients treated at home according to the study definition of home treatment, n (% of total study population) . | PE patients treated at home according to the IPDMA definition of home treatment, n (% of previous column) . |
---|---|---|---|---|---|---|---|
Barco et al.25 (HoT-PE) | Evaluate the efficacy and safety of home treatment in low-risk acute PE patient treated with rivaroxaban | May 2014–June 2018 | Negative Hestia rule and no RV dysfunction or intra-cardiac thrombi | 90 | Yes | 520 (100)a | 170 (32)i |
Bledsoe et al.3 | Evaluate the efficacy and safety outpatient treatment in low-risk acute PE patients | January 2013–October 2016 | PESI Class I or II with a list of exclusion criteria including RV dysfunction on echocardiography | 90 | No | 200 (100)b | 192 (96)i |
den Exter et al.28 (Vesta) | Evaluate the utility and safety of the Hestia rule vs. Hestia rule in combination with (NT-pro)BNP testing for selection of outpatient PE treatment | December 2010–February 2014 | Negative Hestia rule with/without negative (NT-pro)BNP testing | 90 | Yes | 513 (93)c | 513 (100)j |
Font et al.27 | Evaluate the feasibility of outpatient treatment in patients with cancer and PE | May 2006–December 2009 | Negative Hestia-like criteria: systolic blood pressure < 100 mmHg, arterial oxygen pressure < 60 mmHg or pulse oximetry < 90%, active bleeding, platelet count ≥50 000/mm3, renal failure, lack of social support, poor treatment compliance, or the presence of other admission criteria according to treating physicians | 90 | Yes | 62 (45)d | 62 (100)d |
Kabrhel et al.29 | Determine whether a protocol combining risk stratification, treatment with rivaroxaban, and defined follow-up is associated with a greater proportion of patients with VTE treated as outpatients | September 2015–unknown | Negative: social or psychological barrier, abnormal vital signs, coronary artery disease or congestive heart failure, elevated troponin, high risk of bleeding, large PE, intermediate PE with RV dysfunction, high-risk DVT | 28 | No | 164 (25)e | 122 (74)k |
Kline et al.30 (MATH-VTE) | Evaluate the safety and efficacy of home treatment with a DOAC in low-risk acute PE patient presented at the emergency department | April 2016–March 2019 | Negative modified Hestia rule or sPESI of 0 plus physician’s judgement | 30 | No | 604 (100)f | 604 (100)f |
Otero et al.26 | Evaluate efficacy and safety of early discharge in patients with low risk according to a clinical prediction rule | February 2005–April 2007 | ≤2 points on a clinical prediction score, haemodynamic instability, troponin ≥ 0.1 ng/mL, saturation < 93%, need for hospitalization for comorbidities, severe chronic obstructive pulmonary disease, severe asthma, active or high risk of bleeding, pregnancy, morbid obesity, or RV dysfunction | 30 | No | 72 (55)g | 0 (0)j |
Roy et al.11 (HOME-PE) | Evaluate safety and efficacy of Hestia vs. sPESI in the selection of outpatient PE treatment | January 2017–July 2019 | Negative Hestia rule or sPESI of 0 (overruling by clinician possible) | 30 | Yes | 739 (38)h | 681 (92)k |
Vinson et al.31 (eSPEED) | Evaluate the effect of an integrated electronic clinical decision support system to facilitate risk stratification and decision for selection of outpatient PE treatment | January 2014–April 2015 | PESI Class I or II with a broad list of relative contraindications from variables from the Ottawa and Hestia exclusion criteria (including absence of RV dysfunction) | 30 | No | 130 (19)c | 116 (89)k |
Zondag et al.9,10 (Hestia) | Evaluate the efficacy and safety of outpatient treatment according to the Hestia rule in patients with acute PE | May 2008–April 2010 | Negative Hestia rule | 90 | Yes | 297 (100)c | 296 (100)j |
Since follow-up was only 28 days in the study by Kabrhel et al., we used 28 days as a surrogate measurement for incidence within 30 days for Kabrhel et al.29
DOAC, direct oral anticoagulant; DVT, deep vein thrombosis; (NT-pro)BNP, N-terminal pro–B-type natriuretic peptide; PE, pulmonary embolism; PESI, pulmonary embolism severity index; RV, right ventricle; sPESI, simplified pulmonary embolism severity index; VTE, venous thromboembolism.
aDischarge from the hospital within 48 h of presentation.
bObservation or hospitalization for >12–<24 h.
cDischarge from the hospital within 24 h of PE diagnosis.
dDischarge within 12 h after PE diagnosis.
eDischarged directly from the ED or admitted to the ED observation unit with a plan for discharge.
fDischarge within 24 h after triage.
gDischarge at 72 or 120 h (61 and 39%, respectively).
hDischarge within 24 h of presentation or randomization.
iWithin 24 h after randomization/inclusion.
jWithin 24 h after acute PE diagnosis.
kWithin 24 h after ED presentation.
Study . | Primary study aim . | Study period . | Selection of low-risk patients . | Follow-up (days) . | Outcome adjudication . | PE patients treated at home according to the study definition of home treatment, n (% of total study population) . | PE patients treated at home according to the IPDMA definition of home treatment, n (% of previous column) . |
---|---|---|---|---|---|---|---|
Barco et al.25 (HoT-PE) | Evaluate the efficacy and safety of home treatment in low-risk acute PE patient treated with rivaroxaban | May 2014–June 2018 | Negative Hestia rule and no RV dysfunction or intra-cardiac thrombi | 90 | Yes | 520 (100)a | 170 (32)i |
Bledsoe et al.3 | Evaluate the efficacy and safety outpatient treatment in low-risk acute PE patients | January 2013–October 2016 | PESI Class I or II with a list of exclusion criteria including RV dysfunction on echocardiography | 90 | No | 200 (100)b | 192 (96)i |
den Exter et al.28 (Vesta) | Evaluate the utility and safety of the Hestia rule vs. Hestia rule in combination with (NT-pro)BNP testing for selection of outpatient PE treatment | December 2010–February 2014 | Negative Hestia rule with/without negative (NT-pro)BNP testing | 90 | Yes | 513 (93)c | 513 (100)j |
Font et al.27 | Evaluate the feasibility of outpatient treatment in patients with cancer and PE | May 2006–December 2009 | Negative Hestia-like criteria: systolic blood pressure < 100 mmHg, arterial oxygen pressure < 60 mmHg or pulse oximetry < 90%, active bleeding, platelet count ≥50 000/mm3, renal failure, lack of social support, poor treatment compliance, or the presence of other admission criteria according to treating physicians | 90 | Yes | 62 (45)d | 62 (100)d |
Kabrhel et al.29 | Determine whether a protocol combining risk stratification, treatment with rivaroxaban, and defined follow-up is associated with a greater proportion of patients with VTE treated as outpatients | September 2015–unknown | Negative: social or psychological barrier, abnormal vital signs, coronary artery disease or congestive heart failure, elevated troponin, high risk of bleeding, large PE, intermediate PE with RV dysfunction, high-risk DVT | 28 | No | 164 (25)e | 122 (74)k |
Kline et al.30 (MATH-VTE) | Evaluate the safety and efficacy of home treatment with a DOAC in low-risk acute PE patient presented at the emergency department | April 2016–March 2019 | Negative modified Hestia rule or sPESI of 0 plus physician’s judgement | 30 | No | 604 (100)f | 604 (100)f |
Otero et al.26 | Evaluate efficacy and safety of early discharge in patients with low risk according to a clinical prediction rule | February 2005–April 2007 | ≤2 points on a clinical prediction score, haemodynamic instability, troponin ≥ 0.1 ng/mL, saturation < 93%, need for hospitalization for comorbidities, severe chronic obstructive pulmonary disease, severe asthma, active or high risk of bleeding, pregnancy, morbid obesity, or RV dysfunction | 30 | No | 72 (55)g | 0 (0)j |
Roy et al.11 (HOME-PE) | Evaluate safety and efficacy of Hestia vs. sPESI in the selection of outpatient PE treatment | January 2017–July 2019 | Negative Hestia rule or sPESI of 0 (overruling by clinician possible) | 30 | Yes | 739 (38)h | 681 (92)k |
Vinson et al.31 (eSPEED) | Evaluate the effect of an integrated electronic clinical decision support system to facilitate risk stratification and decision for selection of outpatient PE treatment | January 2014–April 2015 | PESI Class I or II with a broad list of relative contraindications from variables from the Ottawa and Hestia exclusion criteria (including absence of RV dysfunction) | 30 | No | 130 (19)c | 116 (89)k |
Zondag et al.9,10 (Hestia) | Evaluate the efficacy and safety of outpatient treatment according to the Hestia rule in patients with acute PE | May 2008–April 2010 | Negative Hestia rule | 90 | Yes | 297 (100)c | 296 (100)j |
Study . | Primary study aim . | Study period . | Selection of low-risk patients . | Follow-up (days) . | Outcome adjudication . | PE patients treated at home according to the study definition of home treatment, n (% of total study population) . | PE patients treated at home according to the IPDMA definition of home treatment, n (% of previous column) . |
---|---|---|---|---|---|---|---|
Barco et al.25 (HoT-PE) | Evaluate the efficacy and safety of home treatment in low-risk acute PE patient treated with rivaroxaban | May 2014–June 2018 | Negative Hestia rule and no RV dysfunction or intra-cardiac thrombi | 90 | Yes | 520 (100)a | 170 (32)i |
Bledsoe et al.3 | Evaluate the efficacy and safety outpatient treatment in low-risk acute PE patients | January 2013–October 2016 | PESI Class I or II with a list of exclusion criteria including RV dysfunction on echocardiography | 90 | No | 200 (100)b | 192 (96)i |
den Exter et al.28 (Vesta) | Evaluate the utility and safety of the Hestia rule vs. Hestia rule in combination with (NT-pro)BNP testing for selection of outpatient PE treatment | December 2010–February 2014 | Negative Hestia rule with/without negative (NT-pro)BNP testing | 90 | Yes | 513 (93)c | 513 (100)j |
Font et al.27 | Evaluate the feasibility of outpatient treatment in patients with cancer and PE | May 2006–December 2009 | Negative Hestia-like criteria: systolic blood pressure < 100 mmHg, arterial oxygen pressure < 60 mmHg or pulse oximetry < 90%, active bleeding, platelet count ≥50 000/mm3, renal failure, lack of social support, poor treatment compliance, or the presence of other admission criteria according to treating physicians | 90 | Yes | 62 (45)d | 62 (100)d |
Kabrhel et al.29 | Determine whether a protocol combining risk stratification, treatment with rivaroxaban, and defined follow-up is associated with a greater proportion of patients with VTE treated as outpatients | September 2015–unknown | Negative: social or psychological barrier, abnormal vital signs, coronary artery disease or congestive heart failure, elevated troponin, high risk of bleeding, large PE, intermediate PE with RV dysfunction, high-risk DVT | 28 | No | 164 (25)e | 122 (74)k |
Kline et al.30 (MATH-VTE) | Evaluate the safety and efficacy of home treatment with a DOAC in low-risk acute PE patient presented at the emergency department | April 2016–March 2019 | Negative modified Hestia rule or sPESI of 0 plus physician’s judgement | 30 | No | 604 (100)f | 604 (100)f |
Otero et al.26 | Evaluate efficacy and safety of early discharge in patients with low risk according to a clinical prediction rule | February 2005–April 2007 | ≤2 points on a clinical prediction score, haemodynamic instability, troponin ≥ 0.1 ng/mL, saturation < 93%, need for hospitalization for comorbidities, severe chronic obstructive pulmonary disease, severe asthma, active or high risk of bleeding, pregnancy, morbid obesity, or RV dysfunction | 30 | No | 72 (55)g | 0 (0)j |
Roy et al.11 (HOME-PE) | Evaluate safety and efficacy of Hestia vs. sPESI in the selection of outpatient PE treatment | January 2017–July 2019 | Negative Hestia rule or sPESI of 0 (overruling by clinician possible) | 30 | Yes | 739 (38)h | 681 (92)k |
Vinson et al.31 (eSPEED) | Evaluate the effect of an integrated electronic clinical decision support system to facilitate risk stratification and decision for selection of outpatient PE treatment | January 2014–April 2015 | PESI Class I or II with a broad list of relative contraindications from variables from the Ottawa and Hestia exclusion criteria (including absence of RV dysfunction) | 30 | No | 130 (19)c | 116 (89)k |
Zondag et al.9,10 (Hestia) | Evaluate the efficacy and safety of outpatient treatment according to the Hestia rule in patients with acute PE | May 2008–April 2010 | Negative Hestia rule | 90 | Yes | 297 (100)c | 296 (100)j |
Since follow-up was only 28 days in the study by Kabrhel et al., we used 28 days as a surrogate measurement for incidence within 30 days for Kabrhel et al.29
DOAC, direct oral anticoagulant; DVT, deep vein thrombosis; (NT-pro)BNP, N-terminal pro–B-type natriuretic peptide; PE, pulmonary embolism; PESI, pulmonary embolism severity index; RV, right ventricle; sPESI, simplified pulmonary embolism severity index; VTE, venous thromboembolism.
aDischarge from the hospital within 48 h of presentation.
bObservation or hospitalization for >12–<24 h.
cDischarge from the hospital within 24 h of PE diagnosis.
dDischarge within 12 h after PE diagnosis.
eDischarged directly from the ED or admitted to the ED observation unit with a plan for discharge.
fDischarge within 24 h after triage.
gDischarge at 72 or 120 h (61 and 39%, respectively).
hDischarge within 24 h of presentation or randomization.
iWithin 24 h after randomization/inclusion.
jWithin 24 h after acute PE diagnosis.
kWithin 24 h after ED presentation.
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