title: Magnetic resonance venography to assess thrombus resolution with edoxaban monotherapy versus parenteral anticoagulation/warfarin for symptomatic deep vein thrombosis: A multicenter feasibility study.
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.
authors.affiliation: Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA gpiazza@partners.org.
authors.forename: Gregory
authors.initials: G
authors.lastname: Piazza
authors.affiliation: Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: Venkatesh
authors.initials: V
authors.lastname: Mani
authors.affiliation: Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Samuel Z
authors.initials: SZ
authors.lastname: Goldhaber
authors.affiliation: Daiichi Sankyo Pharma Development, Edison, NJ, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Grosso
authors.affiliation: Daiichi Sankyo Pharma Development, Edison, NJ, USA.
authors.forename: Michele
authors.initials: M
authors.lastname: Mercuri
authors.affiliation: Daiichi Sankyo Pharma Development, Edison, NJ, USA.
authors.forename: Hans J
authors.initials: HJ
authors.lastname: Lanz
authors.affiliation: Daiichi Sankyo Pharma Development, Edison, NJ, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Schussler
authors.affiliation: Daiichi Sankyo Pharma Development, Edison, NJ, USA.
authors.forename: Ching
authors.initials: C
authors.lastname: Hsu
authors.affiliation: Daiichi Sankyo Pharma Development, Edison, NJ, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Chinigo
authors.affiliation: Division of Hematology, Department of Medicine, University of Alberta, Edmonton, AB, Canada.
authors.forename: Bruce
authors.initials: B
authors.lastname: Ritchie
authors.affiliation: Lewin and Nadar Cardiology Associates, Camp Hill, PA, USA.
authors.forename: Venkatesh
authors.initials: V
authors.lastname: Nadar
authors.affiliation: Wilmington Health, Wilmington, NC, USA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Cannon
authors.affiliation: St James Healthcare, Butte, MT, USA.
authors.forename: John
authors.initials: J
authors.lastname: Pullman
authors.affiliation: Intercoastal Medical Group, Sarasota, FL, USA.
authors.forename: Mauricio
authors.initials: M
authors.lastname: Concha
authors.affiliation: Lafayette Regional Vein and Laser Center, Lafayette, IN, USA.
authors.forename: Marlin
authors.initials: M
authors.lastname: Schul
authors.affiliation: Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: Zahi A
authors.initials: ZA
authors.lastname: Fayad
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001777:Blood Coagulation / Q000187:drug effects*; D004359:Drug Therapy, Combination; D065427:Factor Xa Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D019934:International Normalized Ratio; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D010690:Phlebography / Q000379:methods*; D011237:Predictive Value of Tests; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D020246:Venous Thrombosis / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D014859:Warfarin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D011725:Pyridines; D013844:Thiazoles; D014859:Warfarin; D006493:Heparin; C552171:edoxaban
keywords: MRV; anticoagulation; deep vein thrombosis; edoxaban; magnetic resonance; venous thromboembolism eTRIS