http://circoutcomes.ahajournals.org/content/9/2/126.abstract?etoc
A Systematic Review and Meta-Analysis
- Robert J. Romanelli, PhD, MPH,
- Laura Nolting, BS,
- Marina Dolginsky, BS,
- Eunice Kym, PharmD and
- Kathleen B. Orrico, PharmD
+ Author Affiliations
- Correspondence to Robert J. Romanelli, PhD, MPH, Palo Alto Medical Foundation Research Institute, 795 El Camino Real Ames Bldg, Palo Alto, CA 94301. E-mail romanellir@pamfri.org
Abstract
Background—Trial
data for the benefits and risks of dabigatran versus warfarin in the
treatment of nonvalvular atrial fibrillation are
lacking. We sought to review real-world
observational evidence for the comparative effectiveness and safety of
these agents.
Methods and Results—A
systematic search of multiple databases was conducted from first
available date to March 10, 2015 for longitudinal, observational
studies comparing dabigatran with warfarin.
Two reviewers evaluated studies for eligibility and extracted hazard
ratios for
ischemic stroke and gastrointestinal and
intracranial bleeding. hazard ratios were pooled using random-effects
meta-analysis.
Metaregression was performed to assess
treatment-effect heterogeneity. We identified 232 unique citations.
Seven retrospective
cohort studies met study eligibility
criteria, with 348 750 patients and a mean follow-up of 2.2 years. In
pooled analyses,
dabigatran-150 mg was not superior to
warfarin in preventing stroke (hazard ratio, 0.92; 95% confidence
interval, 0.84–1.01;
P=0.066), but had a significantly lower hazard of intracranial bleeding (0.44; 0.34–0.59; P<0.001). Dabigatran-150 mg had a significantly greater hazard of gastrointestinal bleeding than warfarin (1.23; 1.01–1.50;
P=0.041), which was potentiated in
studies of older (elderly) versus younger populations (median/mean age,
≥75 versus <75 years;
β=1.53; 95% confidence interval, 1.10–2.14; P=0.020).
Conclusions—In
real-world clinical practice, dabigatran is comparable with warfarin in
preventing ischemic stroke among patients with
nonvalvular atrial fibrillation. However,
dabigatran is associated with a lower risk for intracranial bleeding
relative to
warfarin, but—particularly among the
elderly—a greater risk for gastrointestinal bleeding. Bleeding outcomes
from observational
studies are consistent with those from the
pivotal Randomized Evaluation of Long-Term Anticoagulation Therapy
trial.
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