CC BY 4.0 · TH Open 2020; 04(01): e59-e65
DOI: 10.1055/s-0040-1705137
Original Article
Georg Thieme Verlag KG Stuttgart · New York

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

Alex C. Spyropoulos
1  The 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 States
,
Concetta Lipardi
2  Janssen Research & Development, LLC, Raritan, New Jersey, United States
,
Jianfeng Xu
2  Janssen Research & Development, LLC, Raritan, New Jersey, United States
,
Colleen Peluso
2  Janssen Research & Development, LLC, Raritan, New Jersey, United States
,
Theodore E. Spiro
3  Thrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, New Jersey, United States
,
Yoriko De Sanctis
3  Thrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, New Jersey, United States
,
Elliot S. Barnathan
2  Janssen Research & Development, LLC, Raritan, New Jersey, United States
,
Gary E. Raskob
4  College of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
› Author Affiliations
Funding Bayer U.S. LLC and Janssen Research & Development LLC sponsored the MAGELLAN trial and the analyses reported here.
Further Information

Publication History

27 November 2019

27 January 2020

Publication Date:
13 March 2020 (online)

  

Abstract

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.

Note

All authors contributed equally to the manuscript: (1) conception and design of the work, analysis and interpretation of the data; (2) drafting the work or revising it critically for important intellectual content including: Introduction, Methods, Results, Discussion; (3) final approval of the version to be published; (4) agreement to be accountable for all aspects of the work in ensuring that the questions related to the accuracy or integrity of any part.