• R D Murray, A Shah, S E Jasper, A Goodman, S R Deitcher, W E Katz, J F Malouf, M F Stoddard, R A Grimm, A L Klein, and ACUTE II pilot study.
• Steering and Publications Committee of ACUTE II, Cleveland, Ohio, USA.
• Am. Heart J. 2000 Jun 1; 139 (6): E1-7.

BackgroundPatients 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.ObjectiveTo 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 SettingThis is a randomized, multicenter clinical trial at 11 hospitals in the United States.Patients And InterventionTwo 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 MeasuresFeasibility 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 ImplicationsThe 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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