Table 2:
Risk-of-Bias Assessment for the Effectiveness of the LAAC Device Versus Novel Oral Anticoagulants With Warfarin as a Common Comparator
| Study, Yeara | Selection Biasb | Performance Biasc | Detection Biasd | Attrition Biase | Reporting Biasf | Sum Bias | |||
|---|---|---|---|---|---|---|---|---|---|
| Stroke | Mortality | Hem. Stroke | Isch. Stroke | ||||||
| RELY, 200915 | Low | Low | Low | Low | Low | Low | Low | Low | Low |
| ARISTOTL E, 201116 | Low | Low | Low | Low | Low | Low | Unclear | Low | Low |
| ROCKET AF, 201117 | Low | Low | Low | Low | Low | Low | Low | Low | Low |
| J ROCKET AF, 201218 | Low | Low | Low | Low | Low | Low | Low | Low | Low |
| ENGAGE AF, 201319 | Low | Low | Low | Low | Low | Low | Low | Low | Low |
| PREVAIL, 201420 | Low | Unclear | Unclear | Unclear | Unclear | Low | Low | Low | Unclear |
| PROTECT AF, 201421 | Low | Unclear | Unclear | Unclear | Unclear | Low | Low | Low | Unclear |
All studies were double-blinded randomized controlled trials except for PREVAIL and PROTECT AF, which were randomized but not double-blinded.
Selection bias refers to bias with regard to random sequence generation and allocation concealment.
Performance bias refers bias with regard to the blinding of participants and study personnel.
Detection bias refers to bias with regard to the blinding of outcome assessment.
Attrition bias refers to incomplete outcome data.
Reporting bias refers to selective reporting.