IV. Discussion
Using a registry of Japanese patients with NVAF, we examined their
eligibility for Phase III trials comparing DOACs with warfarin.
Approximately 50% of our “real world” registered patients with NVAF
were ineligible following the inclusion and exclusion criteria we
derived from reports of Phase III trials. Further comparative analysis
of outcomes strongly suggested that eligibility may affect the outcomes
in our patients, with significantly higher risks of major bleeding,
stroke/systemic embolism, and all-cause death in ineligible patients.