Table 2.
GRADE summary of findings for clopidogrel plus aspirin versus aspirin alone for the treatment of acute minor ischaemic stroke or high risk transient ischaemic attack (TIA)
| Outcome | Study results and measurements | Absolute effect estimates | Certainty in effect estimates (quality of evidence) | Plain text summary | |
|---|---|---|---|---|---|
| Aspirin alone | Clopidogrel and aspirin | ||||
| All non-fatal recurrent stroke | Relative risk 0.70 (9% CI 0.61 to 0.8). Based on data from 10 301 patients in three studies.* Follow-up 90 days | 63/1000 | 44/1000 | High | Dual antiplatelet therapy has small but important benefit in reducing recurrent strokes |
| Difference: 19 fewer per 1000 (95% CI 25 fewer to 13 fewer) | |||||
| All cause mortality | Relative risk 1.27 (95% CI 0.73 to 2.23). Based on data from 9690 patients in two studies.† Follow-up 90 days | 5/1000 | 6/1000 | Moderate: due to serious imprecision‡ | Dual antiplatelet therapy probably has little or no impact on all-cause mortality |
| Difference: 1 more per 1000 (95% CI 2 fewer to 4 more) | |||||
| Moderate or major extracranial haemorrhage defined by individual study (non-fatal) | Relative risk 1.71 (95% CI 0.92 to 3.20). Based on data from 10 075 patients in three studies.* Follow-up 90 days | 3/1000 | 5/1000 | Moderate: due to serious risk of bias and imprecisionठ| Dual antiplatelet therapy probably results in small, possibly important increase in moderate or major extracranial bleeding |
| Difference: 2 more per 1000 (95% CI 0 fewer to 7 more) | |||||
| Functional disability measure by modified Rankin Scale score 2-5 (non-fatal) | Relative risk 0.90 (95% CI 0.81 to 1.01). Based on data from 9690 patients in two studies.† Follow-up 90 days | 142/1000 | 128/1000 | Moderate: due to serious imprecision‡ | Dual antiplatelet therapy possibly has a small but important benefit on patient function |
| Difference: 14 fewer per 1000 (95% CI 27 fewer to 1 more) | |||||
| Poor quality of life measured by EQ-5D index score of ≤0.5 | Relative risk 0.81 (95% CI 0.66 to 1.01). Based on data from 5131 patients in one study¶ | 68/1000 | 55/1000 | Moderate: due to serious imprecision‡ | Dual antiplatelet therapy probably has a s mall important benefit on quality of life |
| Difference: 13 fewer per 1000 (95% CI 23 fewer to 1 more) | |||||
| Recurrent TIA | Relative risk 0.90 (95% CI 0.71 to 1.14). Based on data from 9916 patients in two studies.† Follow-up 90 days | 40/1000 | 36/1000 | Moderate: due to serious imprecision‡ | Dual antiplatelet therapy probably has little or no impact on recurrent TIA |
| Difference: 4 fewer per 1000 (95% CI 12 fewer to 6 more) | |||||
| Mild or minor extracranial bleeding events | Relative risk 2.22 (95% CI 1.60 to 3.08). Based on data from 10 075 patients in three studies* | 6/1000 | 13/1000 | High | Dual antiplatelet therapy results in a small and possibly important increase in mild extracranial bleeding |
| Difference: 7 more per 1000 (95% CI 4 more to 12 more) | |||||
Systematic review with included studies: POINT 2018, FASTER 2007, CHANCE 2013 Baseline/comparator: POINT 2018.
Systematic review with included studies: POINT 2018, CHANCE 2013 Baseline/comparator: POINT 2018
Imprecision: Serious. Wide confidence intervals;
Risk of bias: Serious. POINT was stopped earlier than scheduled, resulting in potential for overestimating benefits. Imprecision: confidence interval includes a small reduction in risk and a large relative increase.
Systematic review with included studies: CHANCE 2013 Baseline/comparator: Control arm of reference used for intervention.