Abstract
Background: The publication of high-quality observational studies (OSs) has fueled reassessment of the treatment effects of direct oral anticoagulants (DOACs) in the elderly with atrial fibrillation (AF).Methods: The MEDLINE, EMBASE, and Cochrane Library databases were systematically searched (through July 1, 2019) for eligible OSs and randomized controlled trials (RCTs) that reported effectiveness outcomes [stroke or systemic embolism (SE)] or safety outcomes [intracranial hemorrhage (ICH), major bleeding, gastrointestinal bleeding (GIB), myocardial infarction (MI), and all-cause mortality] for DOACs and vitamin-K antagonists (VKAs) in elderly AF patients. A random-effects model was applied to calculate adjusted hazard ratios (HRs) for OSs and relative risks (RRs) for RCTs. Interaction analyses and the ratio of HR (RHR) were used to assess and compare OSs and RCTs.Results: A total of 32 studies involving 547,419 patients were included. No significant difference in treatment effect estimates was found between 27 OSs and 5 RCTs [Pinteraction > 0.05 for each and all 95% confidence interval (CI) of RHR crossed 1.0]. Compared with VKAs, DOACs significantly reduced risk for stroke/SE (OSs, HR: 0.87, 95% CI: 0.81–0.94; RCT, RR: 0.82, 95% CI: 0.67–0.96), and ICH (OSs: 0.47 [0.37–0.57]; RCTs: 0.47 [0.31–0.63]), without increasing risk for GIB (OSs: 1.21 [0.98–1.43]; RCTs: 1.34 [0.91–1.77]), and all-cause mortality (OSs: 1.01 [0.92–1.11]; RCTs: 0.94 [0.87–1.00]). Among OSs, DOACs significantly decreased risk for major bleeding (0.87 [0.77–0.98]) and MI (0.89 [0.79–0.99]). It was found that dabigatran, but not other DOACs, significantly increased risk for GIB (1.48 [1.23–1.72]).Conclusions: DOACs were demonstrated to be more effective and safer than VKAs in elderly AF patients, whereas dabigatran users had a 48% increase in risk for GIB.
Highlights
Atrial fibrillation (AF) prevalence increases with age, from 0.1% at age 75 years [1, 2]
This study provides a comprehensive overview of the benefits and harms associated with Direct oral anticoagulants (DOACs) in elderly AF patients
The pooled results from 27 observational studies (OSs) or 5 randomized controlled trials (RCT) revealed that DOACs reduced the risk for stroke/systemic embolism (SE), intracranial hemorrhage (ICH), major bleeding, and myocardial infarction (MI), and had a similar risk for gastrointestinal bleeding (GIB) and all-cause mortality when compared to Vitamin K antagonists (VKAs)
Summary
Atrial fibrillation (AF) prevalence increases with age, from 0.1% at age 75 years [1, 2]. AF patients aged ≥75 years are considered to have an increased risk factor in the stroke risk-stratification tool and contribute 1 point to the CHADS2 score and 2 points to the CHA2DS2VASc score. Direct oral anticoagulants (DOACs: dabigatran, rivaroxaban, apixaban, and edoxaban et al.) have favorable practical advantages and efficacy, meaning they represent an alternative to Vitamin K antagonists (VKAs) [5,6,7]. The publication of high-quality observational studies (OSs) has fueled reassessment of the treatment effects of direct oral anticoagulants (DOACs) in the elderly with atrial fibrillation (AF)
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