Statistical analysis
Continuous variables were presented as means ± standard deviations (SD),
and categorical variables were presented as frequency and percentage.
Clinical features between groups were compared using the Student’s
t-test for continuous measures and the chi-square test for categorical
variables. The Kaplan-Meier method was used for graphical assessment of
time-dependent events. The log-rank (Mantel-Cox) test was used to
compare clinical event outcomes, and the Mantel-Haenszel method was
applied to determine hazard ratios. Multivariable Cox regression model
(enter method) was used to identify risk factors independently
associated with the net clinical benefit and clinically relevant
bleeding events, based on the results of the on-treatment analysis.
These indicators with P<0.20 in the univariable analyses were
entered into a multivariable analysis. Multivariable Cox regression
analyses were performed with SPSS 25.0 for Windows (IBM Corp, Armonk,
NY, USA). All other statistical analyses were performed using GraphPad
Prism 7 (GraphPad Inc., La Jolla, CA, USA). It was considered
statistically significant when P<0.05.