Table 2.

Most common types of major bleeds in trials comparing VKAs with DOACs

IndicationNo. of trialsType of major bleedVKADOAC
Atrial fibrillation All major bleeds 1769 2091 
Gastrointestinal 583 (33%) 1005 (48%) 
Intracranial 425 (24%) 272 (13%) 
VTE treatment All major bleeds 263 161 
Gastrointestinal 83 (32%) 50 (31%) 
Intracranial 45 (17%) 17 (11%) 
IndicationNo. of trialsType of major bleedVKADOAC
Atrial fibrillation All major bleeds 1769 2091 
Gastrointestinal 583 (33%) 1005 (48%) 
Intracranial 425 (24%) 272 (13%) 
VTE treatment All major bleeds 263 161 
Gastrointestinal 83 (32%) 50 (31%) 
Intracranial 45 (17%) 17 (11%) 

Only phase 3 trials are included. The number of patients included was higher in the DOAC group than in the VKA group for the studies in atrial fibrillation because the studies with dabigatran and edoxaban included 2 DOAC dose regimens.

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