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LetterLetters

Canadian trial data?

Murray B. Trusler
Canadian Family Physician October 2012; 58 (10) 1081-1082;
Murray B. Trusler
Hot Springs, BC
MD CCFP FCFP
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The recent RxFiles by Kosar et al1 is an excellent and helpful review of oral anticoagulant management in atrial fibrillation (AF). However, some serious questions arise when looking at the “unexpected” high hemorrhagic stroke rates in the warfarin arms of these trials (RELY [Randomized Evaluation of Long-term Anticoagulation Therapy], ROCKET-AF [Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonist for Prevention of Stroke and Embolism Trial in AF], and ARISTOTLE [Apixaban for Reduction in Stroke and Other ThromboemboLic Events in AF]), all of which were conducted multinationally with 39 to 45 countries participating, as opposed to a very low rate of hemorrhagic stroke experienced in the warfarin arm of the SPORTIF V (Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation V) trial (2 events in 1962 patients), which was a North American–only trial of the first novel oral anticoagulant, ximelagatran. Perhaps it would be helpful if the Canadian data from these subsequent trials were published. Is the difference in hemorrhagic stroke rates owing to the change in settings of these studies from North America (the most relevant context for Canadian family physicians) to a multinational arena? What are the differences in the elements of the HAS-BLED score between these studies? What are the ranges of these elements as well?

It only takes a few outlier patients taking acetylsalicylic acid, with uncontrolled hypertension and poor warfarin control, to create large differences in bleed rates. Second, the hemorrhagic stroke issue aside, warfarin is demonstrated to be superior to dabigatran for all other major end points using RELY’s own data when warfarin is managed properly and the average proportion of time the international normalized ratio is in therapeutic range is greater than 72.6%.2 Why is so little attention paid to sensitivity analyses when discussing warfarin? With simple and inexpensive computerized decision support tools, it is possible to achieve time in the therapeutic range of greater than 80%. I believe our most important problem has been poor warfarin management, not warfarin itself. Perhaps a few dollars spent on computerized support tools would be better value for money than the hundreds of millions being spent on switching to novel oral anticoagulants, with no method of monitoring the degree of anticoagulation (a substantial compliance issue), no effective antidote, and no long-term track record.

Footnotes

  • Competing interests

    Dr Trusler was the Chief of Staff of the Moose Factory General Hospital in Ontario where they employed 4S DAWN warfarin management software. This led to a dramatic improvement in the time in therapeutic range to greater than 80%. Dr Niall Davidson (neurologist) and Dr Trusler subsequently sourced and licensed a New Zealand product for Canada called INR Online. They hope to gain government sponsorship for the tool so that it can be available free to all Canadian family physicians to help them improve the time in therapeutic range for all of their patients taking warfarin. So far, they have had no revenue from this venture and a lot of expenses.

  • Copyright© the College of Family Physicians of Canada

References

  1. ↵
    1. Kosar L,
    2. Jin M,
    3. Kamrul R,
    4. Schuster B
    . Oral anticoagulation in atrial fibrillation. Balancing the risk of stroke with the risk of bleed. Can Fam Physician 2012;58:850-8.
    OpenUrlFREE Full Text
  2. ↵
    1. Wallentin L,
    2. Yusuf S,
    3. Ezekowitz MD,
    4. Alings M,
    5. Flather M,
    6. Franzosi MG,
    7. et al
    . Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010;376(9745):975-83.
    OpenUrlCrossRefPubMed
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Canadian Family Physician: 58 (10)
Canadian Family Physician
Vol. 58, Issue 10
1 Oct 2012
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Canadian trial data?
Murray B. Trusler
Canadian Family Physician Oct 2012, 58 (10) 1081-1082;

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