Table 6.
—[Sections 3.2.1-3.2.5] Clopidogrel vs Aspirin for Patients With Recent ACS29
Outcomes | Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute Effects Over
1 y |
|
Risk With Aspirin | Difference With Clopidogrel (95% CI) | ||||
Vascular mortalitya |
19,185 (1 RCT), 1.9 y |
Moderate due to imprecisionb |
RR 0.92 (0.80-1.07) |
60 per 1,000c |
No significant difference; 5 fewer per 1,000 (from 12 fewer
to 4 more) |
MI nonfatal events |
19,185 (1 RCT), 1.9 y |
Moderate due to imprecisionb |
RR 0.85 (0.72-1.00) |
70 per 1,000c |
10 fewer per 1,000 (from 20 fewer to 0 more) |
Stroke includes nonfatal ischemic and hemorrhagic
strokesd |
19,185 (1 RCT), 1.9 y |
High |
RR 0.94 (0.83-1.06) |
20 per 1,000c |
No significant difference; 1 fewer per 1,000 (from 3 fewer
to 1 more) |
Major extracranial bleede | 19,185 (1 RCT), 1.9 y | Highf | RR 0.88 (0.7-1.12) | 30 per 1,000c | No significant difference; 3 fewer per 1,000 (from 9 fewer to 3 more) |
Of the deaths in CAPRIE 27 of 405 (6.7%) with aspirin were fatal bleeding events, and 23 of 372 (6.2%) with clopidogrel were fatal bleeding events.
Rated down for imprecision for MI because of a wide CI, including important benefit and no benefit with clopidogrel.
Control group risk estimates for death, MI, stroke, and bleeding come from the CURE trial (adjusted to 1-y time frame).
Of the strokes in CAPRIE, 24 of 486 (4.9%) with aspirin were hemorrhagic, and 14 of 528 (2.6%) with clopidogrel were hemorrhagic.
Of the major extracranial bleeds in CAPRIE, 68 of 149 (45.6%) with aspirin were GI, and 47 of 132 (35.6%) with clopidogrel were GI.
Our decision not to rate down for imprecision is due to the low control group risk for strokes and major bleeds that result in no important harm of clopidogrel (as judged by the upper limit of the 95% CI for the absolute effect).