Boehringer Ingelheim
Dabigatran Photo courtesy of
LOS ANGELES—A real-world analysis has quantified the risks of stroke and major bleeding in patients with non-valvular atrial fibrillation (NVAF) starting treatment with novel oral anticoagulants (NOACs).
The data showed that patients receiving dabigatran had a significantly lower rate of major bleeding but a similar rate of stroke as patients receiving rivaroxaban.
Rates of stroke and major bleeding were not significantly different in patients receiving dabigatran and those receiving apixaban.
These findings were presented at the International Stroke Conference 2018 (abstract 100). This research was supported by Boehringer Ingelheim, makers of dabigatran. The researchers are employed by, or have received payments from, the company.
“With an increasing number of the 2.7 million Americans living with atrial fibrillation being treated with NOACs, real-world analyses like this that compare their effectiveness and safety are important,” said lead investigator Todd C. Villines, MD, of Walter Reed National Military Medical Center in Bethesda, Maryland.
“As a researcher and treating physician, I hope that this large-scale, US practice-based comparison will provide additional insight on available NOAC therapies . . . .”
In this retrospective, observational study, Dr Villines and his colleagues assessed the safety and effectiveness of NOACs in NVAF patients treated through the US Department of Defense Military Health System.
The researchers analyzed data from patients newly initiating treatment with apixaban, dabigatran, or rivaroxaban.
The team examined 2 cohorts. One resulted in 12,763 propensity-score-matched patients receiving dabigatran (150 mg bid) or rivaroxaban (20 mg daily). The other resulted in 4802 propensity-score- matched patients receiving dabigatran (150 mg bid) or apixaban (5 mg bid).
The primary outcomes in this study were the risk of major bleeding and stroke.
Dabigatran-treated patients had a significantly lower rate of major bleeding than rivaroxaban-treated patients—2.08% (266/12,763) and 2.53% (323/12,763), respectively (hazard ratio [HR]=0.82; 95% confidence interval [CI], 0.70-0.97; P=0.0182).
However, rates of stroke were not significantly different in the dabigatran and rivaroxaban groups—0.60% (77/12,763) and 0.78% (100/12,763), respectively (HR=0.77; 95% CI 0.57-1.04; P=0.0844).
Likewise, there was no significant difference in stroke rates for patients receiving dabigatran and apixaban—0.44% (21/4802) and 0.35% (17/4802), respectively (HR=1.26; 95% CI, 0.66-2.39; P=0.4892].
And there was no significant difference in major bleeding—1.60% (77/4802) and 1.21% (58/4802), respectively (HR=1.37; 95% CI, 0.97-1.94; P=0.0702).
The researchers said limitations of this study include the potential for residual confounding as an observational, on-treatment study. In addition, the study included data from electronic health records, which may not have been optimal to identify baseline risk and outcomes. Finally, there were limited dabigatran users available for matching with apixaban users.
