Roches CoaguChek XS and the SPOC training programme

1
Roches CoaguChek XS and the SPOC training
programme

• Dr. Brigitte Piso
• Medical University of Vienna, Internal Medicine
  I,
• Department of Hematology and Haemostaseology

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CoaguChek XS- Whats new?

• Size
• Test principle (not mechanical/ optical but
  electrochemical)
• New fail-safe features (e.g. integrated quality
  control)
• Reagent insensitive to heparin
• Arrow symbols (if set) for INR values outside the
  individual therapeutic target range

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CoaguChek XS trials

• Calibration study for the master lot (2004)
• successfully calibration of master lot according
  to WHO guidelines,
• mean ISI for CC XS PT Test is 1.01
• Performance evaluation study (2005)
• Comparison with IRPs and commercially available
  human thromboplastins
• confirming successfully calibration/ validity

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CoaguCheck XS trials

• User study (2005)75 patients, 4 sites, 4 weeks
  experience
• Agreement between INR results determined by
  patients and by professionals excellent
• Imprecision of CC XS system very low (CV lt6)
• Handling easy (60, 84), Like the size (98,
  100) apply blood from above/ from the side
  (55/45, 48/52), Placing device on the table
  (63, 71) No need to store test strips in the
  refrigerator (2nd rank in features that were
  liked particularly-open question- after size)

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Experience

• Training patients routinely on CC XS since the
  beginning of this year (73 patients)
• CC XS film for short introduction of the handling
  of the POC device

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Usability

• test strip packing (box) / insertion
• blood sampling
• blood application
• readability

• code number comparison
• setting of device
• English abbreviations

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CoaguChek XS Plus

• for primary and secondary care environments
• Full graphical touch screen
• patient and user identification
• Download capabilities
• 500 result memory

• Mains and battery power supply
• CoaguChek XS Plus PT liquid controls available
• XS strips are compatible

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SPOC?

• in comparison with
• The Austrian ( Österreichische
  Arbeitsgruppe zur Selbstkontrolle der oralen
  Antikoagulation) training programme
• The SmartCheck INR Training programme

SPOG Schulungs- und Behandlungsprogramm für
Patienten mit oraler Gerinnungshemmung
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General information
Feldkirch
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Training material for trainer
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Training material for patients
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Contents I
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Contents II
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Contents III
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Contents IV
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Characteristics I
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Characteristics II
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Characteristics III
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Changes in SPOG programme

• Due to experiences from the 60 trial we
  discussed the following changes in Graz/ Austria
  in June 2005
• If the anticoagulant treatment has to be
  interrupted, patients are advised, to contact
  their physician for potential heparin-therapy
• The teaching of self- administred Vitamin K
  intake is cancelled. red attention line
  possibility of Vitamin K intake or intermission
  OAC should be discussed with physician

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SPOG 60 Trial

• Einfluss des strukturierten Schulungs- und
  Behandlungsprogramms bei älteren Patienten mit
  oraler Antikoagulation auf die Qualität der
  Therapie sowie Morbidität und Mortalität
• Self-management of oral anticoagulation in the
  elderly a randomized controlled trial.
  Rationale, design, baselines and oral
  anticoagulation control after 1 year of
  follow-up
• Siebenhofer A., Didjurgeit U, Rakovac I,
  Kleespies C, Piso B. Sawicki P. currently under
  review

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SPOG 60 Background

• atrial fibrillation increases with age (10 of
  patients aged gt80 years)
• OAC therapy to prevent stroke and decrease stroke
  associated mortality
• reluctance in prescribing OAC
• bleeding risk is in fact twice as great in those
  over 70 years of age
• regularly INR monitoring

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SPOG 60 Inclusion criteria

• Long-term OAC treatment
• Phenprocoumon or acenocoumarol
• Age gt 60 years
• No previous participation in PSM trial
• No severe cognitive impairment
• No terminal illness

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SPOG 60 Methods I

• Duration
• Recruitment from March 2002 to Feb. 2005 (about
  40 of eligible patients participated)
• Study end Feb 2007
• 4 study centers/ central randomization to
• Routine care group (RCG) single 90 minute
  information session INR determination as usual
  in general practice or hospital-based specialized
  anticoagulation clinic
• Self management Group (SMG) 4 training sessions
  (weekly, 90 to 120 minutes each)

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SPOG 60 Methods II

• Follow up
• every 6 months clinical examination, questions
  about bleeding/ thromboembolic events,
  hospitalisations ..., copy patients diaries
• Outcome measures
• Primary combined endpoint of all thromboembolic
  events and all major bleeding complications
  requiring hospitalisation
• Secondary hospitalisation, mortality, INR gt 4.5
  or gt 1.7, QoL, cost-effectiveness
• Tertiary mean square deviation percentage of
  INR values/ time spent in therapeutic target
  range

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SPOG 60 Results after one year

• will be published soon
• no surprises, in line with results of PSM studies
  with younger patients

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Thank you for your attention!
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SPOG 60 Results after one year

• Percentage of INR in range/ time in range or mean
  square deviation
• SMG superior to RCG
• Improvement between pre-study and first year in
  SMG (unchanged in RCG)
• Hospital-based specialized anticoagulation clinic
  superior to general practices
• No difference in thromboembolic/bleeding events