Dronedarone vs class Ic agents for early AF: Protocol for the DRIVE-AF randomized clinical trial

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Background Early rhythm control is crucial in atrial fibrillation (AF), yet clinical equipoise remains regarding the optimal initial antiarrhythmic drug (AAD). While Class Ic agents are widely used, their safety profile often necessitates complex co-administration with rate-control drugs, potentially limiting adherence. Dronedarone offers distinct safety advantages, but direct randomized comparisons with Class Ic agents in early AF are lacking. Objective To test the hypothesis that dronedarone is non-inferior to Class Ic AADs regarding efficacy (AF recurrence) and superior regarding safety (drug discontinuation due to adverse events). Methods The DRIVE-AF trial is a prospective, multicenter, randomized, open-label trial conducting at 14 academic centers in Korea. The study will enroll 1,898 patients diagnosed with AF within 12 months who require AAD therapy. Participants will be randomized (1:1) to receive either dronedarone (400 mg twice daily) or standard-of-care Class Ic agents (flecainide or propafenone) for 12 months. Results The dual primary endpoints are AF recurrence at 12 months (non-inferiority) and drug discontinuation due to adverse events (superiority). Secondary outcomes include AF-specific quality of life, medication adherence (Proportion of Days Covered), and major adverse cardiovascular events. Analyses will be performed on both intention-to-treat and per-protocol bases. Conclusions DRIVE-AF is the first large-scale randomized trial directly comparing the "safety-first" strategy of dronedarone against the traditional Class Ic strategy. By establishing comparative efficacy and safety, this study aims to refine international standards for pharmacologic rhythm control in early atrial fibrillation.

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