Sensitivity Analyses
The annual rates and HRs for the analyses of the effectiveness and safety composites in the IPTW treatment groups in an intent-to-treat are shown in Supplementary Table S12 and Figure 5 (HRs only). Under intent-to-treat analyses, rivaroxaban 20 mg present a better effectiveness composite (HR 0.79; 95% CI 0.65–0.96), and the observed improvement in the effectiveness composite was driven by a reduction in mortality (HR 0.72; 95% CI 0.58–0.91). Those point estimates are in relation to those observed in the IPTW treatment groups in an on-treatment, and the level of significance is linked to an increase of the number of events, particularly among those in the warfarin group.
As shown in Table 2, the rate per 100 person-years of hospitalization for diabetes complications were similar for warfarin and DOACs, with no significant HRs. As expected, the results were similar in all the groups. As shown in Table 3, the E-value closest to boundary 1 for the effectiveness composite and apixaban 5.0 mg vs. warfarin was 1.53; hence, the HR that this effectiveness composite could be explained by an unmeasured confounder occurred 1.53 times more frequently in patients receiving apixaban 5.0 mg than in patients receiving warfarin, and thus increased the rate of safety composite events by a factor of 1.53. The high E-values indicate that the statistically significant results are robust with regards to unmeasured confounding factors.