Left Ventricular Dysfunction Among Patients With Embolic Stroke of Undetermined Source and the Effect of Rivaroxaban vs Aspirin: A Subgroup Analysis of the NAVIGATE ESUS Randomized Clinical Trial
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View abstract on PubMed
Summary
This summary is machine-generated.Rivaroxaban reduced recurrent stroke risk more than aspirin in patients with embolic strokes of undetermined source and left ventricular dysfunction. This finding emerged from a post hoc analysis of the NAVIGATE ESUS trial.
Area Of Science
- Cardiology
- Neurology
- Clinical Trials
Background
- Recurrent stroke risk in patients with embolic strokes of undetermined source (ESUS) and left ventricular (LV) dysfunction remains a clinical challenge.
- The comparative efficacy of anticoagulation versus aspirin for secondary stroke prevention in this specific patient subgroup is not well-established.
Purpose Of The Study
- To determine if anticoagulation (rivaroxaban) is superior to aspirin in reducing recurrent stroke in patients with ESUS and LV dysfunction.
- To analyze treatment effects based on the presence or absence of LV dysfunction.
Main Methods
- Post hoc exploratory analysis of the NAVIGATE ESUS phase 3 clinical trial data.
- Included 7107 patients with ESUS, randomized to rivaroxaban (15 mg daily) or aspirin (100 mg daily).
- Assessed recurrent stroke or systemic embolism risk, with LV dysfunction identified via echocardiography.
Main Results
- LV dysfunction was present in 7.1% of participants.
- Among those with LV dysfunction, rivaroxaban showed a lower risk of the primary outcome (HR, 0.36; 95% CI, 0.14-0.93) compared to aspirin.
- Patients without LV dysfunction showed no significant difference in outcomes between rivaroxaban and aspirin (HR, 1.16; 95% CI, 0.93-1.46), with a significant interaction (P=.03).
Conclusions
- Rivaroxaban demonstrated superiority over aspirin in reducing recurrent stroke or systemic embolism in ESUS patients with LV dysfunction.
- These findings suggest a potential benefit of anticoagulation in a specific subgroup of ESUS patients.
- Further research may be warranted to confirm these exploratory findings in prospective studies.
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