Table 2. Summary of Quality Assessments and Findings for Primary and Secondary Outcomes.
Outcomes | Quality Assessment | Summary of Findings | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Events, No./Total No. (%) | Odds Ratio (95% CI) | Control Risk, Events per 1000 Persons | Risk Difference, Increase per 1000 (95% CI) | Quality | ||||||||||
Studies, No. | Serious Limitations | Serious Inconsistency | Serious Indirectness | Serious Imprecision | Publication Bias Detected | NOAC | Aspirin | |||||||
Primary Outcome | ||||||||||||||
Intracranial hemorrhage | ||||||||||||||
Rivaroxaban vs aspirin | ||||||||||||||
15-20 mg daily | 2 | No | No | No | Yes | No | 23/4716 (0.5) |
7/4735 (0.1) |
3.31 (1.42-7.72) |
1 | 3 (1-10) | Moderate | ||
10 mg daily | 3 | No | No | No | Yes | No | 50/12 718 (0.4) |
35/12 761 (0.3) |
1.43 (0.93-2.21) |
3 | NS | Moderate | ||
Apixaban vs Aspirin | 1 | No | No | No | Yes | No | 11/2808 (0.4) |
13/2791 (0.5) |
0.84 (0.38-1.88) |
5 | NS | Moderate | ||
Secondary Outcomes | ||||||||||||||
Fatal bleeding | ||||||||||||||
Rivaroxaban vs aspirin | ||||||||||||||
15-20 mg Daily | 2 | No | No | No | Yes | No | 36/4716 (0.8) |
15/4735 (0.3) |
2.37 (1.3-4.29) |
3 | 4 (1-10) | Moderate | ||
10 mg Daily | 3 | No | No | No | Yes | No | 19/12 718 (0.1) |
13/12 761 (0.1) |
1.47 (0.72-2.97) |
1 | NS | Moderate | ||
Apixaban vs aspirin | 1 | No | No | No | Yes | No | 4/2808 (0.1) |
6/2791 (0.2) |
0.66 (0.19-2.35) |
2 | NS | Moderate | ||
Major bleeding | ||||||||||||||
Rivaroxaban vs aspirin | ||||||||||||||
15-20 mg Daily | 2 | No | No | No | Yes | No | 68/4716 (1.4) |
26/4735 (0.5) |
2.64 (1.68-4.16) |
5 | 9 (4-17) | Moderate | ||
10 mg Daily | 3 | No | No | No | No | No | 221/12 761 (1.7) |
339/12 718 (2.7) |
1.56 (1.31-1.85) |
17 | 9 (5-14) | High | ||
Apixaban vs aspirin | 1 | No | No | No | Yes | No | 44/2808 (1.6) |
39/2791 (1.4) |
1.12 (0.73-1.73) |
14 | NS | Moderate |
Abbreviations: NOACs, non–vitamin K antagonist oral anticoagulants; NS, not significant.