Summary of findings 1. Outpatient versus inpatient treatment for acute pulmonary embolism.
Outpatient versus inpatient treatment for acute pulmonary embolism | ||||||
Patient or population: people with low‐risk acute pulmonary embolism Settings: outpatient and inpatient settings Intervention: outpatient settinga Comparison: inpatient settingb | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No. of participants (RCTs) | Certainty of the evidence (GRADE) | Comments | |
Risk with inpatient setting | Risk with outpatient setting | |||||
Short‐term all‐cause mortality Follow‐up: 7 to 10 days after randomisation |
See comment | — | 453 (2) | ⊕⊕⊝⊝ Lowc | No deaths occurred in either study within this time period. | |
Short‐term all‐cause mortality Follow‐up: to 30 days after randomisation |
Study population | RR 0.33 (0.01 to 7.98) | 453 (2) | ⊕⊕⊝⊝ Lowd | In Aujesky 2011, 1/168 deaths in the inpatient group vs 0/171 deaths in the outpatient group. The death reported by Aujesky 2011 was not PE‐related. No deaths occurred in Peacock 2018. | |
4 per 1000 | 1 per 1000 (0 to 35) | |||||
Long‐term all‐cause mortality Follow‐up: 90 days after randomisation |
Study population | RR 0.98 (0.06 to 15.58) | 451e (2) | ⊕⊕⊝⊝ Lowd | In Aujesky 2011, 1/168 deaths in the inpatient group vs 1/171 deaths in the outpatient group. The deaths reported by Aujesky 2011 were not PE‐related. No deaths occurred in Peacock 2018. | |
4 per 1000 | 4 per 1000 (0 to 68) | |||||
Major bleeding Follow‐up: 14 days after randomisation |
Not estimable | RR 4.91 (0.24 to 101.57) | 445 (2) | ⊕⊕⊝⊝ Lowd | In Aujesky 2011, 0/168 major bleeding events in the inpatient group vs 2/171 major bleeding events in the outpatient group. No major bleeding occurred in Peacock 2018. | |
Major bleeding Follow‐up: 90 days after randomisation |
Not estimable | RR 6.88 (0.36 to 132.14) | 445 (2) | ⊕⊕⊝⊝ Lowd | In Aujesky 2011, 0/168 major bleeding events in the inpatient group vs 3/171 major bleeding events in the outpatient group. No major bleeding occurred in Peacock 2018. | |
Minor bleeding | Study population | RR 1.08 (0.07 to 16.79) | 106 (1) | ⊕⊕⊝⊝ Lowd | One participant in each treatment arm reported minor bleeding. | |
18 per 1000 | 20 per 1000 (1 to 305) | |||||
Recurrent PE Follow‐up: within 90 days |
Not estimable | RR 2.95 (CI 0.12 to 71.85) | 445 (2) | ⊕⊕⊝⊝ Lowd | In Aujesky 2011, 0/168 recurrent PE in inpatient group vs 1/171 recurrent PE in the outpatient group, within 90 days. No recurrent PE occurred in Peacock 2018. | |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio; PE: pulmonary embolism | ||||||
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of the effect. |
aOutpatients received subcutaneous enoxaparin twice daily (Aujesky 2011), or rivaroxaban 15 mg orally twice daily for the first 21 days, followed by 20 mg orally once daily for approximately 69 days, for a total treatment duration of 90 days (Peacock 2018). bIn Aujesky 2011, the inpatient group was admitted to hospital and received subcutaneous enoxaparin 1 mg/kg twice daily. In Peacock 2018, the inpatient group was admitted to hospital and received variable pharmacotherapy (standard‐of‐care treatment). cWe downgraded by two levels as the small sample size means it is unlikely that rare events will be seen and because publication bias could not be discounted. dWe downgraded by two levels due to the overall small sample size, small number of events, imprecision in the confidence intervals and the fact that publication bias could not be discounted. eAdditional information was requested from the study authors, but as they were unable to provide it, we used only the available data.