Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis

An individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical Prevention Registry on Venous Thromboembolism (IM...

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Main Authors: Alex C. Spyropoulos, Concetta Lipardi, Jianfeng Xu, Colleen Peluso, Theodore E. Spiro, Yoriko De Sanctis, Elliot S. Barnathan, Gary E. Raskob
Format: Article
Language:English
Published: Georg Thieme Verlag KG 2020-01-01
Series:TH Open
Subjects:
Online Access:http://www.thieme-connect.de/DOI/DOI?10.1055/s-0040-1705137
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spelling doaj-3770033c4d1b43058b978ef08e426bb12020-11-25T03:31:00ZengGeorg Thieme Verlag KGTH Open2512-94652020-01-010401e59e6510.1055/s-0040-1705137Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended ThromboprophylaxisAlex C. Spyropoulos0Concetta Lipardi1Jianfeng Xu2Colleen Peluso3Theodore E. Spiro4Yoriko De Sanctis5Elliot S. Barnathan6Gary E. Raskob7The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, The Feinstein Institute for Medical Research and Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital, New York, New York, United StatesJanssen Research & Development, LLC, Raritan, New Jersey, United StatesJanssen Research & Development, LLC, Raritan, New Jersey, United StatesJanssen Research & Development, LLC, Raritan, New Jersey, United StatesThrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, New Jersey, United StatesThrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, New Jersey, United StatesJanssen Research & Development, LLC, Raritan, New Jersey, United StatesCollege of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United StatesAn individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE risk score has undergone extensive external validation in medically ill patients for in-hospital use and a modified model was used in the MARINER trial of ET also incorporating an elevated D-dimer. The MAGELLAN study demonstrated efficacy with rivaroxaban but had excess bleeding. This retrospective analysis investigated whether the modified IMPROVE VTE model with an elevated D-dimer could identify a high VTE risk subgroup of patients for ET from a subpopulation of the MAGELLAN study, which was previously identified as having a lower risk of bleeding. We incorporated the modified IMPROVE VTE score using a cutoff score of 4 or more or 2 and 3 with an elevated D-dimer (>2 times the upper limit of normal) to the MAGELLAN subpopulation. In total, 56% of the patients met the high-risk criteria. In the placebo group, the total VTE event rate at Day 35 was 7.94% in the high-risk group and 2.83% for patients in the lower-risk group. A reduction in VTE was observed with rivaroxaban in the high-risk group (relative risk [RR]: 0.68, 95% confidence interval [CI]: 0.51–0.91, p = 0.008) and in the lower-risk group (RR: 0.69, 95% CI: 0.40 -1.20, p = 0.187). The modified IMPROVE VTE score with an elevated D-dimer identified a nearly threefold higher VTE risk subpopulation of patients where a significant benefit exists for ET using rivaroxaban.http://www.thieme-connect.de/DOI/DOI?10.1055/s-0040-1705137venous thromboembolismmedically illd-dimervte risk scoreextended thromboprophylaxis
collection DOAJ
language English
format Article
sources DOAJ
author Alex C. Spyropoulos
Concetta Lipardi
Jianfeng Xu
Colleen Peluso
Theodore E. Spiro
Yoriko De Sanctis
Elliot S. Barnathan
Gary E. Raskob
spellingShingle Alex C. Spyropoulos
Concetta Lipardi
Jianfeng Xu
Colleen Peluso
Theodore E. Spiro
Yoriko De Sanctis
Elliot S. Barnathan
Gary E. Raskob
Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis
TH Open
venous thromboembolism
medically ill
d-dimer
vte risk score
extended thromboprophylaxis
author_facet Alex C. Spyropoulos
Concetta Lipardi
Jianfeng Xu
Colleen Peluso
Theodore E. Spiro
Yoriko De Sanctis
Elliot S. Barnathan
Gary E. Raskob
author_sort Alex C. Spyropoulos
title Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis
title_short Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis
title_full Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis
title_fullStr Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis
title_full_unstemmed Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis
title_sort modified improve vte risk score and elevated d-dimer identify a high venous thromboembolism risk in acutely ill medical population for extended thromboprophylaxis
publisher Georg Thieme Verlag KG
series TH Open
issn 2512-9465
publishDate 2020-01-01
description An individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE risk score has undergone extensive external validation in medically ill patients for in-hospital use and a modified model was used in the MARINER trial of ET also incorporating an elevated D-dimer. The MAGELLAN study demonstrated efficacy with rivaroxaban but had excess bleeding. This retrospective analysis investigated whether the modified IMPROVE VTE model with an elevated D-dimer could identify a high VTE risk subgroup of patients for ET from a subpopulation of the MAGELLAN study, which was previously identified as having a lower risk of bleeding. We incorporated the modified IMPROVE VTE score using a cutoff score of 4 or more or 2 and 3 with an elevated D-dimer (>2 times the upper limit of normal) to the MAGELLAN subpopulation. In total, 56% of the patients met the high-risk criteria. In the placebo group, the total VTE event rate at Day 35 was 7.94% in the high-risk group and 2.83% for patients in the lower-risk group. A reduction in VTE was observed with rivaroxaban in the high-risk group (relative risk [RR]: 0.68, 95% confidence interval [CI]: 0.51–0.91, p = 0.008) and in the lower-risk group (RR: 0.69, 95% CI: 0.40 -1.20, p = 0.187). The modified IMPROVE VTE score with an elevated D-dimer identified a nearly threefold higher VTE risk subpopulation of patients where a significant benefit exists for ET using rivaroxaban.
topic venous thromboembolism
medically ill
d-dimer
vte risk score
extended thromboprophylaxis
url http://www.thieme-connect.de/DOI/DOI?10.1055/s-0040-1705137
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