JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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Transesophageal echocardiography guided enoxaparin antithrombotic strategy for cardioversion of atrial fibrillation: the ACUTE II pilot study.

BACKGROUND: Patients with atrial fibrillation >2 days' duration for whom immediate cardioversion is desired or required are commonly hospitalized for 4 or more days of antithrombotic therapy with intravenous unfractionated heparin and commencement of oral warfarin. For these early cardioversion patients, self-administered low-molecular-weight heparin (enoxaparin sodium) as "bridge" therapy to warfarin may obviate the need for hospitalization and activated partial thromboplastin time monitoring and thus potentially lower costs and enhance utility.

OBJECTIVE: To compare feasibility and safety of a transesophageal echocardiography (TEE)-guided enoxaparin strategy with those of a TEE-guided unfractionated heparin strategy in patients with atrial fibrillation of >2 days' duration undergoing early electrical or chemical cardioversion.

DESIGN AND SETTING: This is a randomized, multicenter clinical trial at 11 hospitals in the United States.

PATIENTS AND INTERVENTION: Two hundred patients with atrial fibrillation >2 days' duration requiring early chemical or electric cardioversion will be enrolled. TEE-guided intravenous unfractionated heparin bridge therapy will be compared with TEE-guided subcutaneous enoxaparin bridge therapy.

OUTCOME MEASURES: Feasibility outcomes are time to hospital discharge, patient quality of life/utility, treatment costs, and sinus rhythm. Safety outcomes are ischemic stroke, transient ischemic attack, systemic embolization, major and minor bleeding, clinical hemodynamic instability, and cardiac and cardioversion-related death for a 5-week period from enrollment.

CLINICAL IMPLICATIONS: The results of this pilot study will have important clinical and economic implications for the antithrombotic management of patients with atrial fibrillation undergoing TEE-guided cardioversion.

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