Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Dabigatran vs Warfarin in Patients with AF
Ann Intern Med; ePub 2017 Nov 14; Go, et al
The incidences of stroke and bleeding with dabigatran compared to warfarin in matched adults with atrial fibrillation treated in practice were consistent with those seen in trials, with the relationship between dabigatran and myocardial infarction (MI) warranting further investigation, according to a recent study. The retrospective cohort included 25,289 patients starting dabigatran therapy and 25,289 propensity score-matched patients starting warfarin therapy between November 2010 and May 2014. Researchers found:
- Those receiving dabigatran did not have significantly different rates of ischemic stroke or extracranial hemorrhage, but were less likely to have intracranial bleeding and more likely to have MI.
- However, the significance of the association between dabigatran use and MI varied in sensitivity analyses and by exposure definition.
- Older patients and those with kidney disease had higher gastrointestinal bleeding rates with dabigatran.
Go AS, Singer DE, Toh S, Cheetham TC, Reichman ME, Graham DJ. Outcomes of dabigatran and warfarin for atrial fibrillation in contemporary practice: A retrospective cohort study. [Published online ahead of print November 14, 2017]. Ann Intern Med. doi:10.7326/M16-1157.
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This real-world observational study was done as follow-up to a question raised in the RE-LY study. In the RE-LY study, 150 mg or 110 mg of dabigatran twice daily was evaluated against adjusted-dose warfarin for stroke prevention in atrial fibrillation.1 Dabigatran doses showed lower intracranial hemorrhage rates and, in older patients, the 150-mg dose led to less ischemic strokes and systemic emboli, but more GI bleeding. A question was raised about the rate of MI, which was initially found to be higher with dabigatran 150 mg, but which additional case findings and analysis showed to not have statistically significant difference. The current study shows that dabigatran has a lower rate of intracranial bleeding than warfarin, and a signal but not significant difference in rate of MI. The higher gastrointestinal bleeding rates in patients aged 75 and older is similar to what was seen in the RE-LY study, but the authors note that this was not seen in a Canadian observational study.2 —Neil Skolnik, MD