Table 10.
Outcomes | No. of Participants (Studies) | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute
Effects |
|
Risk With INR 2-3 | Risk Difference With INR < 2 (95% CI) | ||||
Major hemorrhage per 100 patient-y, various definitions | 78,493 (17 studiesa) | Very lowa,b due to risk of bias, inconsistency | RR 1.1 (0.7-1.7) | Study population | |
|
|||||
6 per 1,000 | 1 more per 1,000 (from 2 fewer to 4 more) | ||||
|
|||||
Moderate | |||||
|
|||||
23 per 1,000 | 2 more per 1,000 (from 7 fewer to 16 more) | ||||
| |||||
Thromboembolism per 100 patient-y | 827 (4 studiesc) | Moderated-f due to risk of bias, large effect, dose-response gradient | RR 3.5 (2.8-4.4) | Study population | |
|
|||||
46 per 1,000 | 115 more per 1,000 (from 83 more to 157 more) | ||||
|
|||||
Moderate | |||||
|
|||||
40 per 1,000 | 100 more per 1,000 (from 72 more to 136 more) |
Eight of the studies were retrospective cohorts.
Four studies showed higher risk of bleeding, with INR < 2.
Only one study had a randomized control design.
No explanation was provided.
At least 2.8 times more frequent thromboembolism.
It is biologically plausible with more thromboembolism at a lower INR.