Table 4.
Global grade summary of findings
| Outcome No. of participants (studies) |
Relative effect (95% CI) |
Anticipated absolute effects (95% CI) | Certainty | What happens | ||
| VKA | DOACs | Difference | ||||
| 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.