Table 14.
Outcomes | Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute Effects Over
6-9 mo |
|
Risk With 1 mo Clopidogrel + Aspirin | Risk Difference With 6-12 mo Clopidogrel + Aspirin (95% CI) | ||||
Total mortalitya |
3,390 (3 RCT), 6-12 mo |
Low due to risk of biasb and imprecisionc |
RR 0.73 (0.48-1.13) |
28 per 1,000d |
No significant difference; 8 fewer per 1,000 (from 15 fewer
to 4 more) |
MI nonfatal events |
4,852 (3 RCTs), 6-12 mo |
Moderate due to risk of biasa |
RR 0.66 (0.50-86) |
28 per 1,000d |
9 fewer per 1,000 (from 14 fewer to 4 fewer) |
Stroked |
2,194 (2 RCTs), 6-12 mo |
Low due to risk of biasa and imprecisionc |
RR 0.46 (0.16-1.32) |
10 per 1,000d |
No significant difference; 5 fewer per 1,000 (from 8 fewer
to 3 more) |
Major extracranial bleede | 5,052 (3 RCTs), 6-12 mo | Low due to risk of biasa and imprecisionc | RR 1.17 (0.86-1.60) | 50 per 1,000d | No significant difference; 8 more per 1,000 (from 7 fewer to 30 more) |
Fatal bleeding events not reported.
Bernardi et al92 and Pekdemir et al90 were not blinded, and there was no placebo control; Bernardi et al stopped early for benefit. The Akbulut et al93 design was unclear (no mention of randomization, but the Health Technology Assessment report referred to it as randomized). Mehta et al89 had variable follow-up.
CIs include important benefit and harm.
Control group risk estimates derived from rates in subjects treated with dual antiplatelet therapy for 1 mo in included trials.
Major bleeding not stratified by type of bleed; unclear whether major bleeding included any fatalities.