The AFFIRM trial: main trial and substudies-what can We expect?

The clinical categorization of patients who present with atrial fibrillation is a major determinant of the most appropriate strategy for rhythm management. For those patients with recurrent atrial fibrillation that has not become permanent the two available strategies are rhythm control and anticoagulation or rate control and anticoagulation. There is no clear evidence that one of these strategies is superior to the other. In the AFFIRM trial these two strategies are being compared to one another in a randomized trial. Patients are randomly assigned to one of the two strategies and the treating physician then uses therapies from an approved menu as clinically indicated. Both pharmacologic and nonpharmacologic therapies are used. An overview of the main study protocol is presented. The primary endpoint is total mortality but there are a number of clinically important secondary endpoints. Several substudies will explore important ancillary questions and some of these are also described. At this time over 3000 patients have been enrolled and the planned enrollment is 4300. Enrollment will end late in 1999 and the last patient enrolled will be followed for two years. The AFFIRM Trial will provide important information concerning the management of atrial fibrillation in a large portion of the patients who have this arrhythmia.