Table 16.
Outcomes | Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute Effects Over 5
y |
|
Risk With Aspirin | Risk Difference With Warfarin (95% CI) | ||||
Total mortality |
1,358 (3 RCT), 23-27 mo |
Low due to risk of biasa and imprecisionb |
RR 0.95 (0.76-1.19) |
193 per 1,000c |
No significant difference; 10 fewer per 1,000 (from 46 fewer to
36 more) |
MId |
1,358 (3 RCT), 23-27 mo |
Low due to risk of biasa and imprecisionb |
RR 0.99 (0.35-2.84) |
33 per 1,000c |
No significant difference; 0 fewer per 1,000 (from 21 fewer to
60 more) |
Strokee |
1,358 (3 RCT), 23-27 mo |
Low due to risk of biasa and imprecisionb |
RR 0.34 (0.13-0.97) |
24 per 1,000c |
16 fewer per 1000 (from 21 fewer to 1 fewer) |
Major extracranial bleedf |
1,358 (3 RCT), 23-27 mo |
Low due to risk of biasa and imprecisionb |
RR 1.97 (0.89-4.3) |
30 per 1,000c |
No significant difference; 29 more per 1,000 (from 3 fewer to 99
more) |
Burden of treatment | Not applicable | High | Warfarin > Aspirin | Warfarin: daily medication, dietary
and activity restrictions, frequent blood testing/monitoring,
increased hospital/clinic visits |
|
Aspirin: daily medication only |
Two of three trials were stopped early (one for benefit, one for slow enrollment); problems with blinding.
Wide CIs include benefit and harm.
Control group risk estimates derived from event rates from aspirin arm of the pooled studies.
Fatal and nonfatal MIs not reported separately in all studies.
Fatal and nonfatal strokes not reported separately in all studies, types of strokes (ischemic/hemorrhagic) not reported.
Definition of major hemorrhage varied.