Table 9.
—[Sections 3.2.1-3.2.5] Prasugrel Plus Aspirin vs Clopidogrel Plus Aspirin in Patients With a Recent ACS and PCI57
Outcomes | Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute Effects Over
1 y |
|
Risk With Clopidogrel and Aspirin | Risk Difference With Prasugrel and Aspirin (95% CI) | ||||
Vascular mortalitya |
13,608 (1 RCT), 14.5 mo |
Low due to inconsistencyb and imprecisionc |
RR 0.89 (0.70-1.12) |
50 per 1,000d |
No significant difference; 5 fewer per 1,000 (from 15 fewer
to 6 more) |
MI nonfatal events |
13,608 (1 RCT), 14.5 mo |
Moderate due to inconsistencyc |
RR 0.76 (0.67-0.85) |
70 per 1,000d |
17 fewer per 1,000 (from 23 fewer to 10 fewer) |
Stroke includes nonfatal ischemic and hemorrhagic
strokese |
13,608 (1 RCT), 14.5 mo |
Low due to inconsistencyb and imprecisionc |
RR 1.02 (0.71-1.45) |
13 per 1,000d |
No significant difference; 0 more per 1,000 (from 4 fewer to
6 more) |
Major extracranial bleed | 13,608 (1 RCT), 14.5 mo | Low due to inconsistencyb and imprecisionc | RR 1.32 (1.03-1.68) | 22 per 1,000d | 7 more per 1,000 (from 0 more to 15 more) |
Fatal bleeds were 0.4% with prasugrel and 0.1% with clopidogrel.
Rated down for inconsistency for all outcomes due to credible subgroup analyses showing net harm for composite end point in certain subgroups.
Rated down for imprecision due to wide CIs suggesting important benefit or harm with prasugrel.
Control group risk estimates come from the event rates in the clopidogrel arm of the PLATO study, adjusted to a 1-y time frame.
Hemorrhagic strokes constituted 0.3% of all strokes in both groups.