title: Quality of oral anticoagulation with phenprocoumon in regular medical care and its potential for improvement in a telemedicine-based coagulation service--results from the prospective, multi-center, observational cohort study thrombEVAL.
abstract: BACKGROUND
  The majority of studies on quality of oral anticoagulation (OAC) therapy with vitamin K-antagonists are performed with short-acting warfarin. Data on long-acting phenprocoumon, which is frequently used in Europe for OAC therapy and is considered to enable more stable therapy adjustment, are scarce. In this study, we aimed to assess quality of OAC therapy with phenprocoumon in regular medical care and to evaluate its potential for optimization in a telemedicine-based coagulation service.
  
  
  METHODS
  In the prospective observational cohort study program thrombEVAL we investigated 2,011 patients from regular medical care in a multi-center cohort study and 760 patients from a telemedicine-based coagulation service in a single-center cohort study. Data were obtained from self-reported data, computer-assisted personal interviews, and laboratory measurements according to standard operating procedures with detailed quality control. Time in therapeutic range (TTR) was calculated by linear interpolation method to assess quality of OAC therapy. Study monitoring was carried out by an independent institution.
  
  
  RESULTS
  Overall, 15,377 treatment years and 48,955 international normalized ratio (INR) measurements were analyzed. Quality of anticoagulation, as measured by median TTR, was 66.3% (interquartile range (IQR) 47.8/81.9) in regular medical care and 75.5% (IQR 64.2/84.4) in the coagulation service (P <0.001). Stable anticoagulation control within therapeutic range was achieved in 63.8% of patients in regular medical care with TTR at 72.1% (IQR 58.3/84.7) as compared to 96.4% of patients in the coagulation service with TTR at 76.2% [(IQR 65.6/84.7); P = 0.001)]. Prospective follow-up of coagulation service patients with pretreatment in regular medical care showed an improvement of the TTR from 66.2% (IQR 49.0/83.6) to 74.5% (IQR 62.9/84.2; P <0.0001) in the coagulation service. Treatment in the coagulation service contributed to an optimization of the profile of time outside therapeutic range, a 2.2-fold increase of stabile INR adjustment and a significant decrease in TTR variability by 36% (P <0.001).
  
  
  CONCLUSIONS
  Quality of anticoagulation with phenprocoumon was comparably high in this real-world sample of regular medical care. Treatment in a telemedicine-based coagulation service substantially improved quality of OAC therapy with regard to TTR level, frequency of stable anticoagulation control, and TTR variability.
  
  
  BACKGROUND
  ClinicalTrials.gov, unique identifier NCT01809015, March 8, 2013.
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. juergen.prochaska@unimedizin-mainz.de.|2. Medizinische Klinik und Poliklinik, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. juergen.prochaska@unimedizin-mainz.de.
authors.forename: Jürgen H
authors.initials: JH
authors.lastname: Prochaska
authors.affiliation: 2. Medizinische Klinik und Poliklinik, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. sebastian.goebel@unimedizin-mainz.de.|German Center for Cardiovascular Research (DZHK), Partner Site RheinMain, Langenbeckstr. 1, 55131, Mainz, Germany. sebastian.goebel@unimedizin-mainz.de.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Göbel
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. karsten.keller@unimedizin-mainz.de.|2. Medizinische Klinik und Poliklinik, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. karsten.keller@unimedizin-mainz.de.
authors.forename: Karsten
authors.initials: K
authors.lastname: Keller
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. meike.coldewey@unimedizin-mainz.de.|2. Medizinische Klinik und Poliklinik, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. meike.coldewey@unimedizin-mainz.de.
authors.forename: Meike
authors.initials: M
authors.lastname: Coldewey
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. alexander.ullmann@unimedizin-mainz.de.
authors.forename: Alexander
authors.initials: A
authors.lastname: Ullmann
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. heidrun.lamparter@unimedizin-mainz.de.
authors.forename: Heidrun
authors.initials: H
authors.lastname: Lamparter
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. claus.juenger@unimedizin-mainz.de.
authors.forename: Claus
authors.initials: C
authors.lastname: Jünger
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. zaid.albayati@googlemail.com.
authors.forename: Zaid
authors.initials: Z
authors.lastname: Al-Bayati
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. tinabaer@gmx.net.
authors.forename: Christina
authors.initials: C
authors.lastname: Baer
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. ulrich.walter@unimedizin-mainz.de.|German Center for Cardiovascular Research (DZHK), Partner Site RheinMain, Langenbeckstr. 1, 55131, Mainz, Germany. ulrich.walter@unimedizin-mainz.de.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Walter
authors.affiliation: Department of Medicine I, Federal Armed Forces Central Hospital Koblenz, Rübenacher Str. 170, 56072, Koblenz, Germany. christophbickel@bundeswehr.org.
authors.forename: Christoph
authors.initials: C
authors.lastname: Bickel
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. h.tencate@maastrichtuniversity.nl.|Thrombosis Center Maastricht, Cardiovascular Research Institute Maastricht and Maastricht University Medical Center, PO Box 616, 6200 MD, Maastricht, the Netherlands. h.tencate@maastrichtuniversity.nl.
authors.forename: Hugo
authors.initials: H
authors.lastname: ten Cate
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. tmuenzel@uni-mainz.de.|2. Medizinische Klinik und Poliklinik, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. tmuenzel@uni-mainz.de.|German Center for Cardiovascular Research (DZHK), Partner Site RheinMain, Langenbeckstr. 1, 55131, Mainz, Germany. tmuenzel@uni-mainz.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Münzel
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. philipp.wild@unimedizin-mainz.de.|German Center for Cardiovascular Research (DZHK), Partner Site RheinMain, Langenbeckstr. 1, 55131, Mainz, Germany. philipp.wild@unimedizin-mainz.de.|Preventive Cardiology and Preventive Medicine, 2. Medizinische Klinik und Poliklinik, University Medical Center Mainz, Johannes Gutenberg University Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. philipp.wild@unimedizin-mainz.de.
authors.forename: Philipp S
authors.initials: PS
authors.lastname: Wild
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D001777:Blood Coagulation / Q000187:drug effects*; D015331:Cohort Studies; D005060:Europe; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D010644:Phenprocoumon / Q000627:therapeutic use*; D011446:Prospective Studies; D017216:Telemedicine / Q000379:methods*; D014859:Warfarin / Q000008:administration & dosage
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D010644:Phenprocoumon