What is CHANGE AFIB trying to accomplish in light of the findings from EAST?

EAST was a landmark and critically important clinical trial that demonstrated the long-term value of rhythm control (predominantly with antiarrhythmic drug therapy). Alongside EAST, there have also been a fair number of trials focused on catheter ablation as first-line therapy for atrial fibrillation. However, none of these trials focused exclusively on patients with first-detected AF, which accounts for 1 out of 5 hospital admissions for atrial fibrillation in US hospitals. These patients often get prescribed oral anticoagulation and an AV nodal blocker and then go on to have several recurrences before they are referred to a cardiovascular specialist or EP or are offered rhythm control. At present, there are no guideline recommendations for rhythm control in patients with first-detected AF.

The goal of CHANGE AFIB is to determine if up-front rhythm control with a well-tolerated antiarrhythmic medication in patients with a first diagnosis of AF can reduce CV hospitalization or death. One might ask why not randomize to ablation or some other form of rhythm control. It would be unlikely for someone with a first occurrence/diagnosis of AF to immediately undergo ablation. However, if rhythm control therapy is initiated with antiarrhythmic drug therapy up front and they continue to have AF despite medical therapy, then they might be referred earlier for other forms of rhythm control. Thus, the hypothesis is that up-front initiation of rhythm control with dronedarone, will reduce CV events in persons with first-detected AF. We believe that this question is relevant even in practices where catheter ablation is considered after symptomatic recurrences. Said another way, we also think that up-front rhythm control will have benefits even in patients who might otherwise have received rhythm control at 3, 6, or 12 months following their first diagnosis.

Finally, in reference back to EAST, if CHANGE AFIB demonstrates improved CV outcomes, there would be two randomized trials demonstrating benefit to early initiation of rhythm control and this would likely lead to a change in the guidelines with stronger advocacy for early initiation of rhythm control.