Pooled estimates of clinical events in studies comparing DOACs vs warfarin in patients with concomitant valve disease and AF
| . | Total patients, n . | OR, events per test period . | Heterogeneity . | |||
|---|---|---|---|---|---|---|
| OR . | 95% CI . | P value . | Q test, P value . | Higgins I2, % . | ||
| No. of bleeds | ||||||
| Overall bleeds | ||||||
| RCTs | 6 851 | 0.89 | 0.61-1.31 | .56 | .04 | 63 |
| Non-RCTs | 91 596 | 0.75 | 0.57-0.97 | .03 | <.01 | 91 |
| Non-RCTs (apixaban only) | 18 663 | 0.28 | 0.01-9.56 | .48 | .01 | 84 |
| GI bleeds, non-RCTs | 40 206 | 0.47 | 0.07-3.23 | .44 | <.01 | 100 |
| Intracranial bleeds, non-RCTs | 23 683 | 0.45 | 0.31-0.64 | <.01 | .16 | 35 |
| Stroke incidence | ||||||
| RCTs | 2 123 | 0.87 | 0.56-1.36 | .54 | .59 | 0 |
| Non-RCTs | 94 352 | 0.66 | 0.47-0.93 | .02 | <.01 | 89 |
| TIAs, non-RCTs | 17 562 | 1.11 | 0.85-1.45 | .81 | .12 | 45 |
| Systemic/arterial embolism, non-RCTs | 3 872 | 2.18 | 0.89-5.32 | .09 | .77 | 0 |
| All-cause mortality | ||||||
| RCTs | 2 123 | 0.89 | 0.67-1.17 | .40 | .75 | 0 |
| Non-RCTs | 78 418 | 0.77 | 0.54-1.09 | .14 | <.01 | 93 |
| . | Total patients, n . | OR, events per test period . | Heterogeneity . | |||
|---|---|---|---|---|---|---|
| OR . | 95% CI . | P value . | Q test, P value . | Higgins I2, % . | ||
| No. of bleeds | ||||||
| Overall bleeds | ||||||
| RCTs | 6 851 | 0.89 | 0.61-1.31 | .56 | .04 | 63 |
| Non-RCTs | 91 596 | 0.75 | 0.57-0.97 | .03 | <.01 | 91 |
| Non-RCTs (apixaban only) | 18 663 | 0.28 | 0.01-9.56 | .48 | .01 | 84 |
| GI bleeds, non-RCTs | 40 206 | 0.47 | 0.07-3.23 | .44 | <.01 | 100 |
| Intracranial bleeds, non-RCTs | 23 683 | 0.45 | 0.31-0.64 | <.01 | .16 | 35 |
| Stroke incidence | ||||||
| RCTs | 2 123 | 0.87 | 0.56-1.36 | .54 | .59 | 0 |
| Non-RCTs | 94 352 | 0.66 | 0.47-0.93 | .02 | <.01 | 89 |
| TIAs, non-RCTs | 17 562 | 1.11 | 0.85-1.45 | .81 | .12 | 45 |
| Systemic/arterial embolism, non-RCTs | 3 872 | 2.18 | 0.89-5.32 | .09 | .77 | 0 |
| All-cause mortality | ||||||
| RCTs | 2 123 | 0.89 | 0.67-1.17 | .40 | .75 | 0 |
| Non-RCTs | 78 418 | 0.77 | 0.54-1.09 | .14 | <.01 | 93 |
Unless a specific DOAC is indicated in brackets (apixaban, edoxaban, or rivaroxaban only), the result represents a pooled estimate for all DOACs.