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Published on: February 28, 2012
Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA
Renato D Lopes1, Christopher B Granger1, Daniel M Wojdyla1
1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Insights
Apixaban significantly reduced stroke risk in patients with subclinical atrial fibrillation and high CHA2DS2-VASc scores. Benefits of apixaban outweigh risks for high-risk patients, while aspirin may be preferred for low-risk individuals.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- The ARTESiA trial investigated apixaban versus aspirin in patients with device-detected subclinical atrial fibrillation.
- Apixaban reduced stroke and systemic embolism (SE) but increased major bleeding compared to aspirin.
Purpose of the Study:
- To evaluate the efficacy and safety of apixaban based on baseline CHA2DS2-VASc scores in patients with subclinical atrial fibrillation.
- To inform clinical decision-making regarding apixaban use in this patient population.
Main Methods:
- A subgroup analysis of the ARTESiA trial was performed.
- Patients were stratified by baseline CHA2DS2-VASc scores (<4, =4, >4).
- Relative and absolute differences in stroke/SE and major bleeding rates were assessed.
Main Results:
- In patients with CHA2DS2-VASc >4, apixaban showed a stroke rate of 0.98%/year vs. 2.25%/year for aspirin, preventing 1.28 strokes/SE per 100 patient-years.
- For CHA2DS2-VASc <4, apixaban had a stroke/SE rate of 0.85%/year vs. 0.97%/year for aspirin.
- For CHA2DS2-VASc =4, apixaban prevented 0.32 strokes/SE per 100 patient-years and caused 0.28 major bleeds per 100 patient-years.
Conclusions:
- Apixaban offers greater benefits than risks for patients with subclinical atrial fibrillation and CHA2DS2-VASc scores >4.
- For patients with CHA2DS2-VASc scores <4, the risks of apixaban may outweigh the benefits.
- Treatment decisions for patients with intermediate CHA2DS2-VASc scores (=4) should consider individual patient preferences.
Background:
ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation) demonstrated that apixaban, compared with aspirin, significantly reduced stroke and systemic embolism (SE) but increased major bleeding in patients with subclinical atrial fibrillation.
Objectives:
To help inform decision making, the authors evaluated the efficacy and safety of apixaban according to baseline CHA2DS2-VASc score.
Methods:
We performed a subgroup analysis according to baseline CHA2DS2-VASc score and assessed both the relative and absolute differences in stroke/SE and major bleeding.
Results:
Baseline CHA2DS2-VASc scores were <4 in 1,578 (39.4%) patients, 4 in 1,349 (33.6%), and >4 in 1,085 (27.0%). For patients with CHA2DS2-VASc >4, the rate of stroke was 0.98%/year with apixaban and 2.25%/year with aspirin; compared with aspirin, apixaban prevented 1.28 (95% CI: 0.43-2.12) strokes/SE per 100 patient-years and caused 0.68 (95% CI: -0.23 to 1.57) major bleeds. For CHA2DS2-VASc <4, the stroke/SE rate was 0.85%/year with apixaban and 0.97%/year with aspirin. Apixaban prevented 0.12 (95% CI: -0.38 to 0.62) strokes/SE per 100 patient-years and caused 0.33 (95% CI: -0.27 to 0.92) major bleeds. For patients with CHA2DS2-VASc =4, apixaban prevented 0.32 (95% CI: -0.16 to 0.79) strokes/SE per 100 patient-years and caused 0.28 (95% CI: -0.30 to 0.86) major bleeds.
Conclusions:
One in 4 patients in ARTESiA with subclinical atrial fibrillation had a CHA2DS2-VASc score >4 and a stroke/SE risk of 2.2% per year. For these patients, the benefits of treatment with apixaban in preventing stroke/SE are greater than the risks. The opposite is true for patients with CHA2DS2-VASc score <4. A substantial intermediate group (CHA2DS2-VASc =4) exists in which patient preferences will inform treatment decisions. (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; NCT01938248).
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