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Published on: February 28, 2012
Real-World Effectiveness and Safety of Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial
Yu Yang1, Chin-Yao Shen2, Michael Chun-Yuan Cheng2
1Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region (Y.Y., V.K.C.Y.).
Background:
Whether direct oral anticoagulants (DOACs) are a safe and effective alternative to warfarin in patients with atrial fibrillation and mitral stenosis (AF-MS) remains controversial.
Objective:
To evaluate the effectiveness and safety of DOACs versus warfarin in patients with AF-MS.
Design:
Observational cohort study using target trial emulation.
Setting:
Population-wide insurance claims data in Taiwan.
Participants:
Patients diagnosed with AF-MS and prescribed either DOACs or warfarin between 1 January 2011 and 31 December 2021 were included in the study.
Intervention:
DOACs or warfarin.
Measurements:
Absolute risk differences (RDs) and risk ratios (RRs) at 1 year and 5 years of follow-up for ischemic stroke, systemic embolism, composite stroke, myocardial infarction (MI), intracranial hemorrhage, gastrointestinal bleeding, bleeding at other critical sites, and all-cause death.
Results:
Compared with warfarin, DOACs were associated with an increased risk for ischemic stroke (RD, 4.97 percentage points [95% CI, 1.27 to 8.57 percentage points]; RR, 1.22 [CI, 1.05 to 1.41]) and composite stroke (RD, 5.56 percentage points [CI, 1.77 to 8.97 percentage points]; RR, 1.23 [CI, 1.07 to 1.42]) and a decreased risk for MI (RD, -1.61 percentage points [CI, -3.17 to -0.03 percentage points]; RR, 0.61 [CI, 0.37 to 0.99]) at the 1-year follow-up. Rivaroxaban increased the risk for ischemic stroke during both short- and long-term follow-up periods. The 2 groups did not differ in risks for bleeding or all-cause death.
Limitation:
Limited sample size, lack of detailed information on MS severity, and lack of international normalized ratio measurements.
Conclusion:
In Asian patients with AF-MS, DOACs were associated with an increased 1-year risk for stroke but a decreased risk for MI compared with warfarin.
Primary Funding Source:
Research Grants Council of Hong Kong.
Insights
Direct oral anticoagulants (DOACs) may increase stroke risk but decrease heart attack risk in Asian patients with atrial fibrillation and mitral stenosis (AF-MS) compared to warfarin. Bleeding and death risks were similar.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- The safety and efficacy of direct oral anticoagulants (DOACs) versus warfarin in patients with atrial fibrillation and mitral stenosis (AF-MS) is debated.
- This study addresses the controversy by comparing DOACs and warfarin in this specific patient population.
Purpose of the Study:
- To evaluate the effectiveness and safety of DOACs compared to warfarin in patients diagnosed with atrial fibrillation and mitral stenosis (AF-MS).
Main Methods:
- An observational cohort study utilized target trial emulation with population-wide insurance claims data from Taiwan.
- Patients with AF-MS prescribed either DOACs or warfarin between 2011 and 2021 were analyzed.
- Outcomes assessed included ischemic stroke, systemic embolism, myocardial infarction, bleeding events, and all-cause death at 1- and 5-year follow-ups.
Main Results:
- DOACs were associated with a higher risk of ischemic stroke and composite stroke at 1-year follow-up compared to warfarin.
- A decreased risk for myocardial infarction (MI) was observed with DOACs at 1 year.
- Rivaroxaban specifically showed an increased ischemic stroke risk in both short- and long-term follow-ups. No significant differences in bleeding or all-cause death were found between the groups.
Conclusions:
- In Asian patients with AF-MS, DOACs demonstrated an increased 1-year risk for stroke but a reduced risk for MI compared to warfarin.
- The study highlights potential differential effects of anticoagulants in specific patient subgroups.
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