Table 2.
GRADE Assessment
| Certainty assessment | No of patients | Effect | Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other consideration | DOACs | VKAs | Relative (95% CI) | Absolute (95% CI) | ||
| Composite of arterial thrombotic events | ||||||||||||
| 4 | Randomized trials | Not serious | Not serious | Not serious | Not serious | Very strong association | 24/234 (10.3%) |
3/238 (1.3%) |
OR 5.43 (1.87 to 15.75) |
5 more per 100 (from 1 more to 15 more) |
⨁⨁⨁⨁ High |
CRITICAL |
| Venous thromboembolic events | ||||||||||||
| 4 | Randomized trials | Not serious | Not serious | Not serious | Seriousa | None | 4/234 (1.7%) |
3/238 (1.3%) |
OR 1.20 (0.31 to 4.55) |
0 fewer per 100 (from 1 fewer to 4 more) |
⨁⨁⨁◯ Moderate |
IMPORTANT |
| Major bleeding | ||||||||||||
| 4 | Randomized trials | Not serious | Not serious | Not serious | Seriousa | None | 10/234 (4.3%) |
10/238 (4.2%) |
OR 1.02 (0.42 to 2.47) |
0 fewer per 100 (from 2 fewer to 6 more) |
⨁⨁⨁◯ Moderate |
IMPORTANT |
Factors contributing to the certainty of evidence include the risk of bias, inconsistency, indirectness, imprecision, publication bias, and the strength of association. CI = confidence interval; DOACs = direct oral anticoagulants; GRADE = Grading of Recommendations, Assessment, Development and Evaluation; OR = odds ratio; VKAs = vitamin-K antagonists.
Explanations
a.
Low event rate and wide CI with no clear harm or benefit with the use of direct oral anticoagulants.