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.