Magdalena Sobieraj-Teague, MBBS; John Eikelboom, MBBS
In patients with nonvalvular atrial fibrillation, is percutaneous closure of the left atrial appendage (LAA) noninferior to warfarin for preventing stroke?
Randomized controlled trial. ClinicalTrials.gov NCT00129545.
Mean 18 months.
59 sites in the USA and Europe.
707 patients ≥ 18 years of age (mean age 72 y, 70% men) who had nonvalvular atrial fibrillation and CHADS2 risk score ≥ 1. Exclusion criteria included LAA thrombus, patent foramen ovale, mobile aortic atheroma, and symptomatic carotid artery disease.
The LAA was closed percutaneously using the WATCHMAN device, followed by 45 days of warfarin, which was discontinued if transesophageal echocardiography showed complete closure of the LAA or residual peridevice flow < 5 mm in width; after warfarin was stopped, clopidogrel, 75 mg/d, and aspirin, 81 to 325 mg/d, were given to 6 months and aspirin was given alone thereafter (n = 463). The control group received warfarin for the duration of the study with a target international normalized ratio (INR) between 2.0 and 3.0.
Composite efficacy outcome (ischemic or hemorrhagic stroke, cardiovascular or unexplained death, or systemic embolism) and composite safety outcome (major bleeding or procedure-related complication).
100% (intention-to-treat analysis).
Percutaneous closure of the LAA was noninferior to warfarin therapy for efficacy but was associated with increased risk for the composite safety outcome, including serious pericardial effusion in 4.8% of patients (Table).
In patients with atrial fibrillation, percutaneous closure of the left atrial appendage was noninferior to warfarin for preventing stroke but increased adverse events.
Percutaneous closure of the left atrial appendage (LAA) vs warfarin for preventing stroke in atrial fibrillation†
†Abbreviations defined in Glossary. Composite efficacy outcome = ischemic or hemorrhagic stroke, cardiovascular or unexplained death, or systemic embolism; composite safety outcome = major bleeding or procedure-related complication. RRI, NNH, and CI calculated from data in article.
‡Criterion for noninferiority was met because the upper limit of the CI was < 2.0.
Sobieraj-Teague M, Eikelboom J. Percutaneous closure of the left atrial appendage was noninferior to warfarin in atrial fibrillation. Ann Intern Med. ;151:JC5–10. doi: 10.7326/0003-4819-151-10-200911170-02010
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Published: Ann Intern Med. 2009;151(10):JC5-10.
Cardiology, Prevention/Screening, Rhythm Disorders and Devices.
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