Outpatient Treatment of Low-Risk Pulmonary Embolism in the Era of Direct Oral Anticoagulants: A Systematic Review.

Published on Feb 1, 2021in Academic Emergency Medicine3.451
· DOI :10.1111/ACEM.14108
L. Frueh1
Estimated H-index: 1
(Harvard University)
Background Clinical guidelines have supported outpatient treatment of low-risk pulmonary embolism (PE) since 2014, but adoption of this practice has been slow. Direct oral anticoagulant (DOAC) therapy for venous thromboembolism (VTE) is now as common as vitamin K antagonist (VKA) treatment, but data are sparse regarding outcomes for patients with low-risk PE treated with DOACs as outpatients. We conducted a systematic review of literature on outcomes of outpatient management for PE, including comparisons to inpatient treatment and differences by anticoagulant class. Methods We searched Medline, Embase, PubMed, CENTRAL, clinicaltrials.gov, and ICTRN for studies published from January 1980 through February 2019 using a predefined strategy developed with a medical librarian. We included English-language randomized controlled trials (RCTs) and prospective nonrandomized trials (NRTs) of adult patients diagnosed with acute, symptomatic pulmonary embolism and discharged from the emergency department (ED) or within 48 hours. Our primary outcome included four major adverse outcomes (all-cause mortality, PE-related mortality, recurrent VTE, and major bleeding) within 30 and 90 days. A preplanned subanalysis of high-quality studies assessed outcomes associated with different anticoagulation treatment classes. Results Our initial search identified 6,818 records, of which 12 studies (4 RCT, 8 NRT) with a total of 3191 patients were included in the review. All RCTs and six NRTs were determined to have low-moderate risk of bias and were classified as high quality. Outpatients in these studies (n=1814) had rates of 90-day major adverse outcomes below 1%, including all-cause mortality (0.7% [95% CI 0.4-1.2%]), PE-related mortality (0.06% [0.01-0.3%]), recurrent VTE (0.8% [0.5-1.4%]) and major bleeding (0.8% [0.5-1.4%]). Exploratory analysis revealed no association between anticoagulant treatment class and rates of major adverse outcomes. Conclusions Among patients with low-risk PE treated as outpatients, few patients experienced major adverse outcomes such as mortality, recurrent VTE, or major bleeding within 90 days.
#1Yugo Yamashita (Kyoto University)H-Index: 13
#2Takeshi Morimoto (Hyogo College of Medicine)H-Index: 67
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Background:The simplified pulmonary embolism severity index (sPESI) score has been reported to be useful in predicting 30-day mortality for patients with pulmonary embolism, which helps the identif...
#2Guy MeyerH-Index: 54
Last. José Luis ZamoranoH-Index: 112
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New @ESCardio Guidelines for the Diagnosis and Management of Acute #PulmonaryEmbolism developed in collaboration with @EuroRespSoc now available: #cardiotwitter @erspublicationshttp://bit.ly/2HnrJaj
#1Jonathan A C Sterne (UoB: University of Bristol)H-Index: 124
#2Jelena Savović (UoB: University of Bristol)H-Index: 32
Last. Julian P T Higgins (UoB: University of Bristol)H-Index: 134
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Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limitations of the original tool.
#1Madan Raj Aryal (UB: University at Buffalo)H-Index: 16
#2Rohit Gosain (UB: University at Buffalo)H-Index: 7
Last. Peter A. Kouides (UR: University of Rochester)H-Index: 35
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Both apixaban and rivaroxaban have been approved for use in acute venous thromboembolism (VTE). Although indirect comparison through network meta-analyses of randomized trials have been performed to compare the efficacy and safety of these agents, further comparison between these agents was lacking until recently. We sought to systematically review and carry out a meta-analysis of studies to further compare apixaban with rivaroxaban from multiple studies done in the real-world settings. Studies ...
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#2W. Frank Peacock (BCM: Baylor College of Medicine)H-Index: 62
Last. Concetta Crivera (Janssen Pharmaceutica)H-Index: 18
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Introduction Various risk stratification methods exist for patients with pulmonary embolism (PE). We used the simplified Pulmonary Embolism Severity Index (sPESI) as a risk-stratification method to understand the Veterans Health Administration (VHA) PE population.
#1Pamela L. Lutsey (UMN: University of Minnesota)H-Index: 69
#2Rob F Walker (UMN: University of Minnesota)H-Index: 4
Last. Neil A. Zakai (UVM: University of Vermont)H-Index: 42
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Background: Direct oral anticoagulants (DOACs), namely rivaroxaban, apixaban, dabigatran, and edoxaban, are now included together with warfarin as standards of care for the primary treatment of venous thromboembolism (VTE). The extent to which the DOACs have been adopted since receiving US Food and Drug Administration (FDA) approval is unknown. Objective: To document temporal trends in oral anticoagulant (OAC) prescriptions among anticoagulant-naive patients initiating OACs for VTE primary treat...
#1Pamela L. Lutsey (UMN: University of Minnesota)H-Index: 69
#2Neil A. Zakai (UVM: University of Vermont)H-Index: 42
Last. Alvaro Alonso (Emory University)H-Index: 95
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: Understanding of the comparative bleeding risks of oral anticoagulant (OAC) therapies for the primary treatment of venous thromboembolism (VTE) is limited. Therefore, among anticoagulant-naive VTE patients, we conducted comparisons of apixaban, rivaroxaban and warfarin on the rate of hospitalised bleeding within 180 days of OAC initation. MarketScan databases for the time-period from 2011 to 2016 were used and, for each OAC comparison, new users were matched with up to five initiators of a dif...
#5Veli-Pekka Harjola (UH: University of Helsinki)H-Index: 51
AIMS: To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. METHODS AND RESULTS: We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracar...
#1Ashwin S. Nathan (Leonard Davis Institute of Health Economics)H-Index: 11
#2Zhi Geng (Leonard Davis Institute of Health Economics)H-Index: 1
Last. Peter W. GroeneveldH-Index: 33
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Background: Beginning in 2012, direct oral anticoagulants (DOACs) were approved for treatment and prevention of venous thromboembolism. Prior investigations have demonstrated slow rates of adoption...
Cited By4
#1Pierre-Marie Roy (University of Angers)H-Index: 36
#2Andrea Penaloza (UCL: Université catholique de Louvain)H-Index: 15
Last. Laura M. FaberH-Index: 11
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Aims null The aim of this study is to compare the Hestia rule vs. the simplified Pulmonary Embolism Severity Index (sPESI) for triaging patients with acute pulmonary embolism (PE) for home treatment. null Methods and results null Normotensive patients with PE of 26 hospitals from France, Belgium, the Netherlands, and Switzerland were randomized to either triaging with Hestia or sPESI. They were designated for home treatment if the triaging tool was negative and if the physician-in-charge, taking...
#1Mark D Rivera-Morales (Hospital Corporation of America)
#2Jesse C. Wu (Hospital Corporation of America)H-Index: 8
Last. Latha GantiH-Index: 8
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#1William B. Stubblefield (VUMC: Vanderbilt University Medical Center)H-Index: 5
#2Jeffrey A. Kline (IU: Indiana University)H-Index: 78
Venous thromboembolism (VTE) includes the diagnosis of either deep venous thrombosis (DVT) and/or pulmonary embolism (PE). Venous thromboembolism is a major healthcare burden world-wide with an increasing incidence in both Europe and the United States over the last two decades. The majority of patients diagnosed with VTE in the acute care setting are at low risk for an adverse event. Outpatient treatment for patients deemed low-risk by validated clinical decision tools leads to safe, efficacious...
#1Lauren M. Westafer (UMMS: University of Massachusetts Medical School)H-Index: 7
#2Meng-Shiou Shieh (UMMS: University of Massachusetts Medical School)H-Index: 12
Last. Peter K. Lindenauer (UMMS: University of Massachusetts Medical School)H-Index: 62
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Objective While guidelines recommend outpatient management of patients with low-risk pulmonary embolism (PE), little is known about the disposition of patients with PE diagnosed in United States emergency departments (EDs). We sought to determine disposition practices and subsequent health care utilization in patients with acute PE in U.S. EDs. Methods This was a retrospective cohort study of adult ED patients with a new diagnosis of acute PE treated at 740 U.S. acute care hospitals from July 1,...
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