A multicenter trial of vena cava filters in severely injured patients

Kwok M. Ho, Sudhakar Rao, Stephen Honeybul, Rene Zellweger, Bradley Wibrow, Jeffrey Lipman, Anthony Holley, Alan Kop, Elizabeth Geelhoed, Tomas Corcoran, Philip Misur, Cyrus Edibam, Ross I. Baker, Jenny Chamberlain, Claire Forsdyke, Frederick B. Rogers

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Abstract

BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter.

Original languageEnglish
Pages (from-to)328-337
Number of pages10
JournalNew England Journal of Medicine
Volume381
Issue number4
DOIs
Publication statusPublished - 25 Jul 2019

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Vena Cava Filters
Multicenter Studies
Pulmonary Embolism
Wounds and Injuries
Injury Severity Score
Control Groups
Confidence Intervals
Incidence
Anticoagulants
Cause of Death
Ultrasonography
Leg
Angiography
Thrombosis
Randomized Controlled Trials

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Ho, Kwok M. ; Rao, Sudhakar ; Honeybul, Stephen ; Zellweger, Rene ; Wibrow, Bradley ; Lipman, Jeffrey ; Holley, Anthony ; Kop, Alan ; Geelhoed, Elizabeth ; Corcoran, Tomas ; Misur, Philip ; Edibam, Cyrus ; Baker, Ross I. ; Chamberlain, Jenny ; Forsdyke, Claire ; Rogers, Frederick B. / A multicenter trial of vena cava filters in severely injured patients. In: New England Journal of Medicine. 2019 ; Vol. 381, No. 4. pp. 328-337.
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abstract = "BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9{\%} in the vena cava filter group and 14.4{\%} in the control group; hazard ratio, 0.99; 95{\%} confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7{\%}) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95{\%} CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter.",
author = "Ho, {Kwok M.} and Sudhakar Rao and Stephen Honeybul and Rene Zellweger and Bradley Wibrow and Jeffrey Lipman and Anthony Holley and Alan Kop and Elizabeth Geelhoed and Tomas Corcoran and Philip Misur and Cyrus Edibam and Baker, {Ross I.} and Jenny Chamberlain and Claire Forsdyke and Rogers, {Frederick B.}",
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Ho, KM, Rao, S, Honeybul, S, Zellweger, R, Wibrow, B, Lipman, J, Holley, A, Kop, A, Geelhoed, E, Corcoran, T, Misur, P, Edibam, C, Baker, RI, Chamberlain, J, Forsdyke, C & Rogers, FB 2019, 'A multicenter trial of vena cava filters in severely injured patients' New England Journal of Medicine, vol. 381, no. 4, pp. 328-337. https://doi.org/10.1056/NEJMoa1806515

A multicenter trial of vena cava filters in severely injured patients. / Ho, Kwok M.; Rao, Sudhakar; Honeybul, Stephen; Zellweger, Rene; Wibrow, Bradley; Lipman, Jeffrey; Holley, Anthony; Kop, Alan; Geelhoed, Elizabeth; Corcoran, Tomas; Misur, Philip; Edibam, Cyrus; Baker, Ross I.; Chamberlain, Jenny; Forsdyke, Claire; Rogers, Frederick B.

In: New England Journal of Medicine, Vol. 381, No. 4, 25.07.2019, p. 328-337.

Research output: Contribution to journalArticle

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T1 - A multicenter trial of vena cava filters in severely injured patients

AU - Ho, Kwok M.

AU - Rao, Sudhakar

AU - Honeybul, Stephen

AU - Zellweger, Rene

AU - Wibrow, Bradley

AU - Lipman, Jeffrey

AU - Holley, Anthony

AU - Kop, Alan

AU - Geelhoed, Elizabeth

AU - Corcoran, Tomas

AU - Misur, Philip

AU - Edibam, Cyrus

AU - Baker, Ross I.

AU - Chamberlain, Jenny

AU - Forsdyke, Claire

AU - Rogers, Frederick B.

PY - 2019/7/25

Y1 - 2019/7/25

N2 - BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter.

AB - BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter.

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DO - 10.1056/NEJMoa1806515

M3 - Article

VL - 381

SP - 328

EP - 337

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

SN - 0028-4793

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