Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Aug;21(4):361-8.
doi: 10.1177/1358863X16645853. Epub 2016 May 10.

Magnetic resonance venography to assess thrombus resolution with edoxaban monotherapy versus parenteral anticoagulation/warfarin for symptomatic deep vein thrombosis: A multicenter feasibility study

Gregory Piazza  1 , Venkatesh Mani  2 , Samuel Z Goldhaber  3 , Michael A Grosso  4 , Michele Mercuri  4 , Hans J Lanz  4 , Steven Schussler  4 , Ching Hsu  4 , Amy Chinigo  4 , Bruce Ritchie  5 , Venkatesh Nadar  6 , Kevin Cannon  7 , John Pullman  8 , Mauricio Concha  9 , Marlin Schul  10 , Zahi A Fayad  2 ; edoxaban Thrombus Reduction Imaging Study (eTRIS) Investigators
Affiliations
Randomized Controlled Trial

Magnetic resonance venography to assess thrombus resolution with edoxaban monotherapy versus parenteral anticoagulation/warfarin for symptomatic deep vein thrombosis: A multicenter feasibility study

Gregory Piazza et al. Vasc Med. 2016 Aug.

Abstract

The feasibility of magnetic resonance venography (MRV) for measuring change in thrombus volume with a novel anticoagulation regimen versus standard anticoagulation in patients with symptomatic deep vein thrombosis (DVT) has not been assessed. Our aim was to study the feasibility of MRV to measure change in thrombus volume in patients with acute symptomatic objectively confirmed proximal DVT in an open-label multicenter trial (edoxaban Thrombus Reduction Imaging Study, eTRIS). We randomized patients in a 2:1 allocation ratio to edoxaban 90 mg/day for 10 days followed by 60 mg/day versus parenteral anticoagulation bridging to warfarin for 3 months. The primary efficacy outcome was a surrogate end point of the relative change in MRV-quantified thrombus volume from baseline to Day 14-21. A total of 85 eligible patients from 26 study sites were randomized to edoxaban monotherapy (n=56) versus parenteral anticoagulation as a 'bridge' to warfarin (n=29). The mean relative change in MRV-quantified thrombus volume from baseline to Day 14-21 was similar in patients treated with edoxaban and parenteral anticoagulation as a 'bridge' to warfarin (-50.1% vs -58.9%; 95% confidence interval of treatment difference, -12.7%, 30.2%). However, thrombus extension was observed in eight patients in the edoxaban monotherapy group and in none in the warfarin group. Rates of recurrent venous thromboembolism (3.6% vs 3.6%, p=0.45) and clinically relevant non-major bleeding (5.4% vs 7.1%, p=0.34) were also similar. No major bleeds occurred in either on-treatment group during the study period. In conclusion, MRV can assess change in thrombus volume in patients with acute DVT randomized to two different anticoagulant regimens.ClinicalTrials.gov IDENTIFIER NCT01662908: INVESTIGATIONAL NEW DRUG IND APPLICATION EDOXABAN IND # 63266.

Keywords: MRV; anticoagulation; deep vein thrombosis; edoxaban; magnetic resonance; venous thromboembolism eTRIS.

PubMed Disclaimer

Conflict of interest statement

Declaration of conflicting interests: Dr Piazza receives research grant support from Daiichi Sankyo, EKOS, a BTG International Group company, Bristol Myers Squibb, and Janssen. Dr Mani receives consulting fees from Tursiop Inc. and research grant support from Novartis AG and Daiichi Sankyo. Dr Goldhaber receives research grant support from Daiichi Sankyo, EKOS, a BTG International Group company, Bristol Myers Squibb, and Janssen. Drs Grosso, Mercuri, Lanz, Hsu, and Chinigo and Mr Schussler receive salary from Daiichi Sankyo. Drs Ritchie, Nadar, Cannon, Pullman, Concha, Schul, and Fayad receive research grant support from Daiichi Sankyo.

Figures

Figure 1.
Figure 1.
Flow of patients through each stage of the trial. (DVT, deep vein thrombosis; LMWH, low-molecular weight heparin; mITT, modified intention-to-treat.).
Figure 2.
Figure 2.
Thrombus volume reduction of 60% from baseline to follow-up as measured by magnetic resonance venography (MRV) in a patient with acute deep vein thrombosis (arrows) randomized to treatment with edoxaban.
See this image and copyright information in PMC

References

    1. Abdalla G, Fawzi Matuk R, Venugopal V, et al. The diagnostic accuracy of magnetic resonance venography in the detection of deep venous thrombosis: A systematic review and meta-analysis. Clin Radiol 2015; 70: 858–871. - PubMed
    1. Enden T, Storas TH, Negard A, et al. Visualization of deep veins and detection of deep vein thrombosis (DVT) with balanced turbo field echo (b-TFE) and contrast-enhanced T1 fast field echo (CE-FFE) using a blood pool agent (BPA). J Magn Reson Imaging 2010; 31: 416–424. - PubMed
    1. Kluge A, Mueller C, Strunk J, et al. Experience in 207 combined MRI examinations for acute pulmonary embolism and deep vein thrombosis. AJR Am J Roentgenol 2006; 186: 1686–1696. - PubMed
    1. Ono A, Murase K, Taniguchi T, et al. Deep venous thrombosis: Diagnostic value of non-contrast-enhanced MR venography using electrocardiography-triggered three-dimensional half-Fourier FSE. Magn Reson Med 2010; 64: 88–97. - PubMed
    1. Sampson FC, Goodacre SW, Thomas SM, et al. The accuracy of MRI in diagnosis of suspected deep vein thrombosis: Systematic review and meta-analysis. Eur Radiol 2007; 17: 175–181. - PubMed

Publication types

MeSH terms

Associated data