Table 3.

Pooled estimates of clinical events in studies comparing DOACs vs warfarin in patients with concomitant valve disease and AF

Total patients, nOR, events per test periodHeterogeneity
OR95% CIP valueQ test, P valueHiggins 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 
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 
All-cause mortality 
RCTs 2 123 0.89 0.67-1.17 .40 .75 
Non-RCTs 78 418 0.77 0.54-1.09 .14 <.01 93 
Total patients, nOR, events per test periodHeterogeneity
OR95% CIP valueQ test, P valueHiggins 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 
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 
All-cause mortality 
RCTs 2 123 0.89 0.67-1.17 .40 .75 
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.

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