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Outcomes of Direct Oral Anticoagulants in Patients With Mitral Stenosis
Ju Youn Kim1, Sung-Hwan Kim2, Jun-Pyo Myong3
1Division of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, South Korea.
Insights
Direct oral anticoagulants (DOACs) show promise in preventing thromboembolism for patients with mitral stenosis and atrial fibrillation (AF). This study suggests DOACs may be a safer alternative to warfarin, warranting further investigation.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- Patients with mitral stenosis and atrial fibrillation (AF) require anticoagulation for stroke prevention.
- Previous studies excluded patients with moderate to severe mitral stenosis from direct oral anticoagulant (DOAC) trials.
- This gap highlights the need to evaluate DOAC efficacy in this specific patient population.
Purpose of the Study:
- To validate the efficacy and safety of direct oral anticoagulants (DOACs) in patients diagnosed with mitral stenosis and atrial fibrillation (AF).
- To compare the effectiveness of DOACs against conventional warfarin treatment for stroke prevention in this cohort.
Main Methods:
- Retrospective cohort study utilizing the Health Insurance Review and Assessment Service (HIRA) database in the Republic of Korea.
- Inclusion criteria: diagnosed mitral stenosis and AF, prescribed either DOACs (off-label use) or warfarin.
- Primary efficacy endpoint: ischemic stroke or systemic embolism; Safety endpoint: intracranial hemorrhage.
Main Results:
- A total of 2,230 patients were analyzed.
- DOACs demonstrated a significantly lower rate of thromboembolic events (2.22%/year) compared to warfarin (4.19%/year), with an adjusted hazard ratio of 0.28.
- The rate of intracranial hemorrhage was also lower in the DOAC group (0.49%/year) versus warfarin (0.93%/year).
Conclusions:
- Direct oral anticoagulant (DOAC) use appears promising for preventing thromboembolism in patients with mitral stenosis and atrial fibrillation (AF).
- The findings suggest DOACs may offer a favorable risk-benefit profile compared to warfarin in this population.
- Further validation through randomized controlled trials is recommended to confirm these hypothesis-generating results.
Background:
Patients with mitral stenosis and atrial fibrillation (AF) require anticoagulation for stroke prevention. Thus far, all studies on direct oral anticoagulants (DOACs) have excluded patients with moderate to severe mitral stenosis.
Objectives:
The aim of this study was to validate the efficacy of DOACs in patients with mitral stenosis.
Methods:
The study population was enrolled from the Health Insurance Review and Assessment Service (HIRA) database in the Republic of Korea, and it included patients who were diagnosed with mitral stenosis and AF and either were prescribed DOACs for off-label use or received conventional treatment with warfarin. The primary efficacy endpoint was ischemic strokes or systemic embolisms, and the safety outcome was intracranial hemorrhage.
Results:
A total of 2,230 patients (mean age 69.7 ± 10.5 years; 682 [30.6%] males) were included in the present study. Thromboembolic events occurred at a rate of 2.22%/year in the DOAC group, and 4.19%/year in the warfarin group (adjusted hazard ratio for DOAC: 0.28; 95% confidence interval: 0.18 to 0.45). Intracranial hemorrhage occurred in 0.49% of the DOAC group and 0.93% of the warfarin group (adjusted hazard ratio for DOAC: 0.53; 95% confidence interval: 0.22 to 1.26).
Conclusions:
In patients with AF accompanied with mitral stenosis, DOAC use is promising and hypothesis generating in preventing thromboembolism. Our results need to be replicated in a randomized trial.
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