Go AS, et al. - A comparative scrutiny was carried out of the incidence of stroke, bleeding, and myocardial infarction in patients receiving dabigatran vs warfarin in a clinical setting. Consistent incidences of stroke and bleeding were yielded with dabigatran vs warfarin with those seen in trials. However, prospective trials were required to comprehend the potential link between dabigatran and myocardial infarction.

Methods

• The scheme of this research was a retrospective cohort study.
• It was performed at the National U.S. Food and Drug Administration Sentinel network.
• The enrollment consisted of adults with atrial fibrillation initiating dabigatran or warfarin therapy between November 2010 and May 2014.
• The measurements comprised of ischemic stroke, intracranial hemorrhage, extracranial bleeding, and myocardial infarction determined from hospital claims among propensity score-matched patients starting treatment with dabigatran or warfarin.

Results

• Individuals receiving dabigatran did not report notably different rates of ischemic stroke (0.80 vs. 0.94 events per 100 person-years; hazard ratio [HR], 0.92 [95% CI, 0.65 to 1.28]) or extracranial hemorrhage (2.12 vs. 2.63 events per 100 person-years; HR, 0.89 [CI, 0.72 to 1.09]), among 25,289 patients starting dabigatran therapy and 25,289 propensity score-matched patients starting warfarin therapy.
• However, they displayed a lesser likelihood of having intracranial bleeding (0.39 vs. 0.77 events per 100 person-years; HR, 0.51 [CI, 0.33 to 0.79]) and a greater tendency of having myocardial infarction (0.77 vs. 0.43 events per 100 person-years; HR, 1.88 [CI, 1.22 to 2.90]).
• A variation was disclosed in the strength and importance of the link between dabigatran use and myocardial infarction, during the sensitivity analyses and by exposure definition (HR range, 1.13 [CI, 0.78 to 1.64] to 1.43 [CI, 0.99 to 2.08]).
• The findings unveiled higher gastrointestinal bleeding rates with dabigatran, in older patients and in those with kidney disease.