Table 7.
Outcomes | Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute Effects Over
1 y |
|
Risk With Aspirin | Risk Difference With Clopidogrel + Aspirin (95% CI) | ||||
Vascular mortalitya |
12,562 (1 RCT), 9 mo |
Moderate due to imprecisionb |
RR 0.93 (0.79-1.08) |
60 per 1,000c |
No significant difference; 4 fewer per 1,000 (from 13 fewer
to 5 more) |
MI nonfatal events |
12,562 (1 RCT), 9 mo |
High |
RR 0.77 (0.67-0.89) |
70 per 1,000c |
16 fewer per 1000 (from 23 fewer to 8 fewer) |
Stroke includes nonfatal ischemic and hemorrhagic
strokesd |
12,562 (1 RCT), 9 mo |
Moderate due to imprecisionb |
RR 0.86 (0.63-1.18) |
20 per 1,000c |
No significant difference; 3 fewer per 1,000 (from 7 fewer
to 4 more) |
Major extracranial bleede | 12,562 (1 RCT), 9 mo | Moderate due to imprecisionb | RR 1.38 (1.13-1.67) | 30 per 1,000c | 11 more per 1,000 (from 4 more to 20 more) |
CURE = Clopidogrel in Unstable Angina to Prevent Recurrent Events. See Table 1-3 legends for expansion of other abbreviations.
Of the total deaths in the CURE trial, 15 of 390 (3.8%) with aspirin were fatal bleeding events, and 11 of 359 (3.1%) with clopidogrel were fatal bleeding events.
Rated down for imprecision because wide CIs included benefit and harm.
Control group risk estimates come from event rates in the aspirin arm of the CURE trial (adjusted to 1-y time frame).
Of the strokes in CURE, five of 87 (5.7%) with aspirin were hemorrhagic, and seven of 75 (9.3%) with clopidogrel were hemorrhagic.
Major bleed was defined as a substantially disabling bleed, intraocular bleed leading to the loss of vision, or bleeding necessitating the transfusion of at least 2 units of blood. Of the major extracranial bleeds in CURE, 47 of 169 (27.8%) with aspirin were GI, and 83 of 231 (35.9%) with clopidogrel were GI.