Primary safety outcome
The primary safety outcome occurred with a comparable frequency (4.5% vs. 5.9%; HR, 0.80; 95%CI, 0.38-1.69; P=0.57; Table 3). Among the 10 cases of MB events in the DAPT group, six cases of gastrointestinal bleeding and three of soft tissue bleeding occurred in the first 3 months after DAPT, of which one was fatal, and eight was severe. One soft tissue MB happened 248 days post-implant in a patient taking OAC due to deep vein thrombosis. In the ACT group, 18 cases of MB events, including major gastrointestinal bleeding (n=4), fatal intracranial bleeding (n=2), severe epistaxis (n=1), and fatal spontaneous retroperitoneal hematoma (n=1) during the first 45 days after LAAC under ACT plus aspirin occurred. Eight patients suffered from major gastrointestinal bleeding, and another suffered from fatal intracranial bleeding under DAPT between 45 days and 6 months. One soft tissue MB was documented at 332 days post-implantation under prolonged DAPT due to recent PCI. All cases of intracranial bleeding and the spontaneous retroperitoneal hematoma were fatal.