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RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy)
 

RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy)

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- Background: ...

- Background:
Dabigatran etexilate is one of several oral anticoagulants in clinical trials for the prevention of AF-related thromboembolism, venous thromboembolism, and other conditions for which warfarin had long been the only choice

- Population and treatment:
18 113 patients with AF (mean age 71) and at least one other risk factor for stroke
Randomized to blinded treatment with dabigatran 110 mg or 150 mg twice a day or unblinded prophylaxis with warfarin adjusted to an INR of 2.0–3.0

- Primary outcome:
Stroke/peripheral embolic events

See the article at http://www.theheart.org/article/995769.do

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RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy) Presentation Transcript

  • RE-LY (Randomized Evaluation of Long-Term Anticoagulant Therapy)
    • Background:
      • Dabigatran etexilate is one of several oral anticoagulants in clinical trials for the prevention of AF-related thromboembolism, venous thromboembolism, and other conditions for which warfarin had long been the only choice
    • Population and treatment:
      • 18 113 patients with AF (mean age 71) and at least one other risk factor for stroke
      • Randomized to blinded treatment with dabigatran 110 mg or 150 mg twice a day or unblinded prophylaxis with warfarin adjusted to an INR of 2.0–3.0
    • Primary outcome:
      • Stroke/peripheral embolic events
    MD Ezekowitz (Lankenau Institute for Medical Research, Wynnewood, PA) European Society of Cardiology 2009 Congress
  • Efficacy results at two years
    • High-dose dabigatran reduced the annualized risk of the primary end point by 34% (p<0.001) and the risk of hemorrhagic stroke by 74% (p<0.001) vs warfarin
    • High-dose dabigatran was associated with a slightly but significantly (p=0.048) increased risk of MI, a secondary end point
    RE-LY: Results a. Annualized rates b. p values are for superiority unless otherwise indicated c. For noninferiority Outcome a Dabigatran low dose (%) Dabigatran high dose (%) Warfarin (%) Relative risk (95% CI) for low dose vs warfarin p for low dose b Relative risk (95% CI) for high dose vs warfarin p for high dose b Primary end point 1.53 1.11 1.69 0.91 (0.74–1.11) <0.001 c 0.66 (0.53–0.82) <0.001 Mortality 3.75 3.64 4.13 0.91 (0.80–1.03) 0.13 0.88 (0.77–1.00) 0.051 MI 0.72 0.74 0.53 1.35 (0.98–1.87) 0.07 1.38 (1.00–1.91) 0.048 Hemorrhagic stroke 0.12 0.10 0.38 0.31 (0.17–0.56) <0.001 0.26 (0.14–0.49) <0.001 Major bleeding 2.71 3.11 3.36 0.80 (0.69–0.93) 0.003 0.93 (0.81–1.07) NS
  • RE-LY: Commentary* *All comments from RE-LY: Oral antithrombin dabigatran outshines warfarin in atrial fib (http://www.theheart.org/article/995769.do) &quot;The effect of dabigatran in reducing stroke and intracerebral bleeds far outweighed the small increase in MI rate, but this is a question we will be looking into in much more detail.&quot; - Dr Michael D Ezekowitz &quot;Dabigatran, I think will be the new gold standard.&quot; - Dr Albert L Waldo &quot;An anticoagulant that actually is more effective than warfarin and doesn't have the side effect of increased bleeding? It's almost never happened before, it's remarkable.&quot; - Dr Stuart J Connolly (first author)