DESIGN OF A CLINICAL-TRIAL FOR THE ASSESSMENT CARDIOVERSION USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (THE ACUTE MULTICENTER STUDY)

Patients with atrial fibrillation (AF) undergoing cardioversion are at an increased risk of cardioembolic stroke and require anticoagulation , The Assessment of Cardioversion Using Transesophageal Echocardiograp hy (ACUTE) Multicenter Study is a randomized clinical trial of patient s undergoing electrical cardioversion of AF of >2 days' duration compa ring a transesophageal-guided strategy (TEE) with brief anticoagulatio n to the conventional anticoagulation strategy. patients randomly assi gned to the TEE-guided strategy receive therapeutic anticoagulation be fore TEE and cardioversion, followed by 4 weeks of anticoagulation, Pa tients with thrombus imaged by TEE have postponement of cardioversion, continue anticoagulation for 3 weeks, and undergo a repeat TEE, Conve ntional strategy patients receive 3 weeks of anticoagulation before ca rdioversion, followed by 4 weeks of anticoagulation after cardioversio n, The primary end point events are ischemic stroke, transient ischemi c attack, and systemic embolization for an 8-week period from enrollme nt, Secondary end points are major and minor bleeding, all-cause morta lity, successful return to and maintenance of sinus rhythm, and cost e ffectiveness, Analysis is based on the intention-to-treat principle. T he anticipated rates of embolism of 2.9% for conventional strategy and 1.2% for the TEE-guided strategy are based on published research and the completed pilot study, The ACUTE Multicenter Study will randomize therapy and follow an estimated 3,000 patients from 65 study sites to determine the relative efficacy of the TEE-guided and conventional app roaches to electrical cardioversion for patients in AF, The results of this investigation will have important clinical implications for the management of patients with AF undergoing electrical cardioversion. (C ) 1998 by Excerpta Medica, Inc.