Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial

Aujesky, Drahomir; Roy, Pierre‐Marie; Verschuren, Franck; Righini, Marc; Osterwalder, Josef Johann; Egloff, Michaël; Renaud, Bertrand; Verhamme, Peter; Stone, Roslyn A.; Legall, C.; Sanchez, Olivier; Pugh, Nathan; Ngako, Alfred; Cornuz, Jacques; Hügli, Olivier; Beer, Jürg H.; Perrier, Arnaud; Fine, Michael J.; Yealy, Donald M.

doi:10.1016/s0140-6736(11)60824-6

Cited by 513 publications

(470 citation statements)

References 41 publications

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“…The remaining 11 studies were included in our systematic review. Eight were prospective cohort studies [8,[11][12][13][31][32][33][34]] and 3 were randomized controlled trials (RCT's) [16,17,35]. Furthermore, 2 studies did not report outcomes at 3 months and could not be used in our pooled meta-analysis [12,13].…”

Section: Resultsmentioning

confidence: 99%

“…Ideally, these rates should be compared to low-risk patients that were hospitalized for the initial management of their acute PE. Unfortunately, only two RCTs compared these risks in patients with acute PE managed as in or out-patients [16,17]. Both RCTs used a risk stratification model (PESI and Uresandi) to identify low risk patients.…”

Section: Discussionmentioning

confidence: 99%

“…Both RCTs used a risk stratification model (PESI and Uresandi) to identify low risk patients. One of the RCTs used several other clinical criteria in addition to the PESI to identify low-risk patients for outpatient management [17] (e- Table 2). Of note, the PESI was derived to predict 30-day all cause mortality but does not include PE-related mortality or VTE recurrence [7].…”

Section: Discussionmentioning

confidence: 99%

“…Two systematic reviews suggested that patients with acute PE treated as outpatients had low incidences of major bleeding, recurrent venous thromboembolism (VTE), and mortality [14,15]. However the quality of the included studies was low and subsequent and recent larger observational studies and randomized control trials were not included [8,11,16,17]. More recently, two additional systematic reviews of the outpatient management of acute symptomatic PE were published [18,19].…”

Section: Introductionmentioning

confidence: 99%

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Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Piran

Gal

Wells

et al. 2013

Thrombosis Research

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134

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Background: Patients with acute deep vein thrombus (DVT) can safely be treated as outpatients. However the role of outpatient treatment in patients diagnosed with a pulmonary embolism (PE) is controversial. We sought to determine the safety of outpatient management of patients with acute symptomatic PE. Materials and Methods: A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews. Pooled proportions for the different outcomes were calculated. Results: A total of 1258 patients were included in the systematic review. The rate of recurrent venous thromboembolism (VTE) in patients with PE managed as outpatients was 1.47% (95% CI: 0.47 to 3.0%; I 2 : 65.4%) during the 3 month follow-up period. The rate of fatal PE was 0.47% (95% CI: 0.16 to 1.0%; I 2 : 0%). The rates of major bleeding and fatal intracranial hemorrhage were 0.81% (95% CI: 0.37 to 1.42%; I 2 : 0%) and 0.29% (95% CI: 0.06 to 0.68%; I 2 : 0%), respectively. The overall 3 month mortality rate was 1.58% (95% CI: 0.71 to 2.80%; I 2 : 45%). The event rates were similar if employing risk stratification models versus using clinical gestalt to select appropriate patients for outpatient management. Conclusions: Independent of the risk stratification methods used, the rate of adverse events associated with outpatient PE treatment seems low. Based on our systematic review and pooled meta-analysis, low-risk patients with acute PE can safely be treated as outpatients if home circumstances are adequate.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Piran

Gal

Wells

et al. 2013

Thrombosis Research

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134

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“…There is growing evidence that selected patients with nonmassive PE can be treated safely on an outpatient basis, provided they are identified as being at low risk using validated prognostic scores [50,51]. The only prospective randomised controlled study available to date [52] is based on the PESI (Pulmonary Embolism Severity Index) score [53] that sets the threshold of low risk at ≤85 points. Considering the fact that each year of age gives one point and male gender 10 points (besides all the 9 other items assessed), it is easy to infer that most elderly patients are not classified at low risk and thus cannot be safely treated as outpatients, a finding which is in accordance with empirical clinical experience.…”

Section: Management Of Pulmonary Embolism In the Elderlymentioning

confidence: 99%

Diagnosis and management of pulmonary embolism in the elderly

Robert‐Ebadi

Righini

2014

European Journal of Internal Medicine

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a b s t r a c t a r t i c l e i n f oElderly patients are a population not only at particularly high risk of venous thromboembolism including pulmonary embolism (PE), but also at high risk of adverse clinical outcomes and treatment-related complications. Major progresses have been achieved in the diagnosis and treatment of PE over the last two decades. Nevertheless, some of elderly patients' specificities still represent important challenges in the management of PE in this population, from its suspicion to its diagnosis and treatment, and are discussed in this review. Perspectives for the future are from a diagnostic point of view the potential implementation of age-adjusted D-dimer cut-offs that will allow ruling out PE in a greater proportion of elderly patients without the need for thoracic imaging. From a therapeutic point of view, acquisition of post-marketing clinical experience with the use of new oral anticoagulants is still necessary, and in the meantime, these drugs should be prescribed with great caution in thoroughly selected elderly patients.

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How to Use a Noninferiority Trial

Mulla¹,

Scott²,

Jackevicius³

et al. 2012

JAMA

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You are an internist seeing a 51-yearold woman with severe osteoarthritis and limited mobility who presents with progressive dyspnea over a 3-day period. She is subjectively in distress, with a pulse rate of 105, a respiratory rate of 28 breaths per minute, and an arterial oxygen saturation of 85% while breathing room air. Aside from her arthritis, the physical examination is unremarkable, and the lower extremity examination shows no sign of deep venous thrombosis. A computed tomographic (CT) pulmonary angiogram reveals unequivocal clot in 2 lobar arteries.Recently, you have been treating patients with deep venous thrombosis without hospital admission using lowmolecular-weight heparin (LMWH) administrationintheoutpatientsetting.You are less comfortable with this approach in the more dangerous setting of pulmonaryembolism.Yourecallreceiving,from the updating service to which you subscribe, a recent trial that addressed this issue. Before discussing the issue of inpatientvsoutpatienttreatmentwithyourpatient, you quickly retire to your office to review the article. 1 In doing so, you find that the trial tested for noninferiority and you wonder, as you begin to read the methods and results, if there are special issues you should consider when using this article to guide your clinical care.

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Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial

Cited by 513 publications

References 41 publications

Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Outpatient treatment of symptomatic pulmonary embolism: A systematic review and meta-analysis

Diagnosis and management of pulmonary embolism in the elderly

How to Use a Noninferiority Trial

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