3.4. Rationale for triple therapy duration

The duration of TAT in the APPROACH-ACS-AF trial is 1–6 months depending on the individual bleeding risk (e.g. HAS-BLED-Score). This corresponds to the most recent guideline recommendation at the time of protocol finalization [5]. In contrast, previous trials test a dual regimen against longer or fixed TAT durations that go beyond the recommendations of both current and contemporarily valid ESC guidelines (see table 1) [14], [15], [17]. This may lead to over-estimation of the potential reductions in bleeding with DAT compared to TAT. The only exception is the ENTRUST-AF trial [16], which used a representative duration of TAT (with a mean duration of 66 days) in line with the current guideline recommendations (table 1). Yet, this latter trial showed a strong trend but failed to show a statistically significant reduction in bleeding events in the dual therapy arm compared to TAT.