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Apixaban vs Aspirin According to CHA2DS2-VASc Score in Patients With Subclinical Atrial Fibrillation
abstract
This abstract is available on the publisher's site.
Access this abstract now Full Text Available for ClinicalKey SubscribersBACKGROUND
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).
Additional Info
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Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA
J Am Coll Cardiol 2024 Jul 23;84(4)354-364, RD Lopes, CB Granger, DM Wojdyla, WF McIntyre, M Alings, T Mani, C Ramasundarahettige, L Rivard, D Atar, DH Birnie, G Boriani, G Amit, P Leong-Sit, C Rinne, GZ Duray, MR Gold, SH Hohnloser, V Kutyifa, J Benezet-Mazuecos, J Cosedis Nielsen, C Sticherling, AP Benz, C Linde, J Kautzner, P Mabo, GH Mairesse, SJ Connolly, JS HealeyFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Context
Device-detected subclinical atrial fibrillation (AF) — captured by a pacemaker, defibrillator, or other implanted device — is associated with an increased risk of stroke. The randomized ARTESiA trial found that, in patients with device-detected subclinical AF, apixaban reduced the risk of stroke but increased the risk of major bleeding compared with aspirin.1 Although roughly half of strokes in patients receiving aspirin were fatal or disabling and approximately 15% of bleeds were fatal, the contrast between efficacy and safety signals has brought about a push to identify subgroups of patients who will benefit most from apixaban. Clinical practice guidelines have previously recommended incorporating the CHA2DS2-VASc score into treatment decisions for this patient population.2,3
Summary
This prespecified secondary analysis of the ARTESiA trial examined the absolute and relative rates of major bleeding according to the patient's baseline CHA2DS2-VASc score. Approximately one-quarter of the patients had a CHA2DS2-VASc score of 5 or higher. In this group, stroke rates were reduced from 2.25% per year on aspirin to 0.98% per year on apixaban, while major bleeding rates increased from 1.45% to 2.13% per year. This benefit clearly outweighed the risks. The opposite was true for approximately 40% of patients with a CHA2DS2-VASc score of 3 or less. In this group, stroke rates were reduced from 0.97% per year on aspirin to 0.85% per year on apixaban, while major bleeding rates increased from 1.11% to 1.44% per year. Approximately one-third of the study population, who had a CHA2DS2-VASc score of 4, demonstrated intermediate results. In this group, stroke rates were reduced from 0.86% per year on aspirin to 0.54% per year on apixaban, while major bleeding rates increased from 0.90% to 1.18% per year.
Take-home message
The CHA2DS2-VASc score is a useful tool for risk-stratifying patients with subclinical device-detected AF. Patients with a CHA2DS2-VASc score of 5 or higher stand to receive substantive net benefit and should be treated with apixaban. Patients with a CHA2DS2-VASc score of 3 or lower are unlikely to benefit and should be treated with aspirin, if clinically indicated; otherwise, they should not receive antithrombotic therapy. Patients with a CHA2DS2-VASc score of 4 present a challenging scenario. Although these patients seem to derive some benefit from oral anticoagulation, the final treatment decisions in this group should be based on the patient's values and preferences.
References