Table 4

Global grade summary of findings

Outcome
No. of participants
(studies)
Relative effect
(95% CI)
Anticipated absolute effects (95% CI)CertaintyWhat happens
VKADOACsDifference
Thromboembolic events
No. of participants: 719
RR 1.69
(1.09 to 2.62)
8.1%13.8%
(8.9 to 21.3)
5.6% more
(0.7 more to 13.2 more)
⨁◯◯◯
Very low*
DOACs may increase the occurrence of thromboembolic events but the evidence is very uncertain.
Major bleeding
No. of participants: 691
RR 1.22
(0.72 to 2.07)
6.6%8.0%
(4.7 to 13.6)
1.4% more
(1.8 fewer to 7 more)
⨁◯◯◯
Very low*†
DOACs may increase the occurrence of major bleeding but the evidence is very uncertain.
All bleeding events
No. of participants: 457
RR 0.79
(0.47 to 1.32)
32.5%25.7%
(15.3 to 42.9)
6.8% fewer
(17.2 fewer to 10.4 more)
⨁◯◯◯
Very low*‡§**
DOACs may decrease the occurrence of all bleeding events but the evidence is very uncertain.
Mortality
No. of participants: 577
RR 1.17
(0.48 to 2.84)
2.7%3.2%
(1.3 to 7.7)
0.5% more
(1.4 fewer to 5 more)
⨁◯◯◯
Very low*††
The effect of DOACs on mortality is very uncertain.
  • *Three RCTs classified as having some concerns and three cohort studies at serious risk of bias.

  • †RR 1.22 (95% CI 0.72 to 2.07).

  • ‡I²=66%.

  • §Mostly no direct comparison.

  • ¶RR 0.79 (95% CI 0.47 to 1.32).

  • **RR 1.17 (95% CI 0.48 to 2.84).

  • ††The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

  • DOACs, direct oral anticoagulants; RR, risk ratio; VKA, vitamin K antagonists.