TY - JOUR
T1 - Emergency Department Discharge of Pulmonary Embolus Patients
AU - Frank Peacock, W.
AU - Coleman, Craig I.
AU - Diercks, Deborah B.
AU - Francis, Samuel
AU - Kabrhel, Christopher
AU - Keay, Catherine
AU - Kline, Jeffrey A.
AU - Manteuffel, Jacob
AU - Wildgoose, Peter
AU - Xiang, Jim
AU - Singer, Adam J.
N1 - Funding Information:
From the Baylor College of Medicine (WFP), Houston, TX; the University of Connecticut School of Pharmacy (CIC), Storrs, CT; the UT Southwestern Medical Center (DD), Dallas, TX; Duke University (SF), Raleigh-Durham, NC; Harvard Medical School (CKa), Boston, MA; the University of Washington (CKe), Seattle, WA; Indiana University (JK), Indianapolis, IN; Henry Ford Hospital (JM), Detroit, MI; Janssen Pharmaceuticals (PW, JX), Newark, NJ; and Stony Brook School of Medicine (AJS), Stony Brook, NY. Received January 13, 2018; revision received April 10, 2018; accepted May 7, 2018. This research was presented as an abstract at the American College of Emergency Physicians Research Forum, Washington, DC, Oct 29, 2017. Funding for this research was provided by Janssen Pharmaceuticals, Raritan, NJ. Consulting for commercial interests, including advisory board work—WFP, CC, DD, and AS have received funding personally from Janssen for consulting. WFP, and CC have received funding personally from Bayer, AG. JK has received grant funding from Janssen for a separate study. Payment for writing independent of grant funding—No author received payment from for writing any part of this manuscript. Employment—PW and JX are employed by Janssen, which manufactures rivaroxaban. Institutional Grant Receipt—WFP, CC, DD, SF, CKa, CKe, JM, and AS’s institution has received funding from Janssen for this investigator-initiated research. Miscellaneous—DD has been a member of the SAEM board of directors. Author Contributions: WFP—study concept and design, acquisition of the data, analysis and interpretation of the data, drafting of the manuscript, critical revision of the manuscript for important intellectual content, statistical expertise, and acquisition of funding. CC—acquisition of the data, analysis and interpretation of the data, critical revision of the manuscript for important intellectual content, and statistical expertise. DD—study concept and design, acquisition of the data, and critical revision of the manuscript for important intellectual content. SK—acquisition of the data and critical revision of the manuscript for important intellectual content. CKa—study concept and design, analysis and interpretation of the data, and critical revision of the manuscript for important intellectual content. CKe—acquisition of the data and critical revision of the manuscript for important intellectual content. JK—study concept and design and critical revision of the manuscript for important intellectual content. JM—acquisition of the data and critical revision of the manuscript for important intellectual content. PW—study concept and design, analysis and interpretation of the data, critical revision of the manuscript for important intellectual content, statistical expertise, and acquisition of funding. JX—analysis and interpretation of the data, critical revision of the manuscript for important intellectual content, and statistical expertise. AS—study concept and design, acquisition of the data, analysis and interpretation of the data, critical revision of the manuscript for important intellectual content, statistical expertise, and acquisition of funding. Supervising Editor: Brian C. Hiestand, MD, MPH. Address for correspondence and reprints: W. Frank Peacock, MD, FACEP; e-mail: Frankpeacock@gmail.com. ACADEMIC EMERGENCY MEDICINE 2018;25:995–1003. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
Publisher Copyright:
© 2018 The Authors. Academic Emergency Medicine published by Wiley Periodicals, Inc. on behalf of Society for Academic Emergency Medicine.
PY - 2018/9
Y1 - 2018/9
N2 - Background: Hospitalization for low-risk pulmonary embolism (PE) is common, expensive, and of questionable benefit. Objective: The objective was to determine if low-risk PE patients discharged from the emergency department (ED) on rivaroxaban require fewer hospital days compared to standard of care (SOC). Methods: Multicenter, open-label randomized trial in low-risk PE defined by Hestia criteria. Adult subjects were randomized to early ED discharge on rivaroxaban or SOC. Primary outcome was total number of initial hospital hours, plus hours of hospitalization for bleeding or venous thromboembolism (VTE), 30 days after randomization. A 90-day composite safety endpoint was defined as major bleeding, clinically relevant nonmajor bleeding, and mortality. Results: Of 114 randomized subjects, 51 were early discharge and 63 were SOC. Of 112 (98.2%) receiving at least one dose of study drug, 99 (86.8%) completed the study. Initial hospital LOS was 4.8 hours versus 33.6 hours, with a mean difference of –28.8 hours (95% confidence interval [CI] = –42.55 to –15.12 hours) for early discharge versus SOC, respectively. At 90 days, mean total hospital days (for any reason) were less for early discharge than SOC, 19.2 hours versus 43.2 hours, with a mean difference of 26.4 hours (95% CI = –46.97 to –3.34 hours). At 90 days, there were no bleeding events, recurrent VTE, or deaths. The composite safety endpoint was similar in both groups, with a difference in proportions of 0.005 (95% CI = –0.18 to 0.19). Total costs were $1,496 for early discharge and $4,234 for SOC, with a median difference of $2,496 (95% CI = –$2,999 to –$2,151). Conclusions: Low-risk ED PE patients receiving early discharge on rivaroxaban have similar outcomes to SOC, but fewer total hospital days and lower costs over 30 days.
AB - Background: Hospitalization for low-risk pulmonary embolism (PE) is common, expensive, and of questionable benefit. Objective: The objective was to determine if low-risk PE patients discharged from the emergency department (ED) on rivaroxaban require fewer hospital days compared to standard of care (SOC). Methods: Multicenter, open-label randomized trial in low-risk PE defined by Hestia criteria. Adult subjects were randomized to early ED discharge on rivaroxaban or SOC. Primary outcome was total number of initial hospital hours, plus hours of hospitalization for bleeding or venous thromboembolism (VTE), 30 days after randomization. A 90-day composite safety endpoint was defined as major bleeding, clinically relevant nonmajor bleeding, and mortality. Results: Of 114 randomized subjects, 51 were early discharge and 63 were SOC. Of 112 (98.2%) receiving at least one dose of study drug, 99 (86.8%) completed the study. Initial hospital LOS was 4.8 hours versus 33.6 hours, with a mean difference of –28.8 hours (95% confidence interval [CI] = –42.55 to –15.12 hours) for early discharge versus SOC, respectively. At 90 days, mean total hospital days (for any reason) were less for early discharge than SOC, 19.2 hours versus 43.2 hours, with a mean difference of 26.4 hours (95% CI = –46.97 to –3.34 hours). At 90 days, there were no bleeding events, recurrent VTE, or deaths. The composite safety endpoint was similar in both groups, with a difference in proportions of 0.005 (95% CI = –0.18 to 0.19). Total costs were $1,496 for early discharge and $4,234 for SOC, with a median difference of $2,496 (95% CI = –$2,999 to –$2,151). Conclusions: Low-risk ED PE patients receiving early discharge on rivaroxaban have similar outcomes to SOC, but fewer total hospital days and lower costs over 30 days.
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U2 - 10.1111/acem.13451
DO - 10.1111/acem.13451
M3 - Article
C2 - 29757489
AN - SCOPUS:85053071143
SN - 1069-6563
VL - 25
SP - 995
EP - 1003
JO - Academic Emergency Medicine
JF - Academic Emergency Medicine
IS - 9
ER -