Table 2.
Association of clopidogrel plus aspirin versus aspirin alone with clinical outcomes in the patients aged <65 years versus ≥65 years.
| Outcomes | Age subgroups | No. (%) of events or median difference | Unadjusted | Adjusted | Pint value | |||
|---|---|---|---|---|---|---|---|---|
| Clopidogrel plus aspirin | Aspirin alone | Treatment difference (95% CI) | p-value | Treatment difference (95% CI) | p-value | |||
| Primary outcome | ||||||||
| mRS score of 0–1 at 90 days | <65 y | 511/655 (78.02) | 467/594 (78.62) | 1.04 (0.79–1.36) | 0.796 | 0.99 (0.75–1.32) | 0.964 | 0.007* |
| ≥65 y | 619/815 (75.95) | 548/767 (71.45) | 0.79 (0.63–0.99) | 0.042* | 0.77 (0.61–0.98) | 0.031* | ||
| Secondary outcomes | ||||||||
| END within 7 d | <65 y | 27/655 (4.12) | 34/594 (5.72) | 1.41 (0.84–2.37) | 0.192 | 1.57 (0.92–2.68) | 0.095 | 0.248 |
| ≥65 y | 35/815 (4.29) | 46/767 (6) | 1.42 (0.91–2.23) | 0.126 | 1.46 (0.93–2.31) | 0.103 | ||
| Change in the NIHSS score at 14 d from baseline | <65 y | −0.56 (−1.1 ~ −0.32) | −0.51 (−0.93 ~ −0.25) | 0.01 (−0.06 to 0.08) | 0.744 | 0.02 (−0.05 to 0.09) | 0.541 | 0.741 |
| ≥65 y | −0.56 (−0.92 ~ −0.22) | −0.56 (−1.1 ~ −0.22) | −0.03 (−0.1 to 0.03) | 0.297 | −0.03 (−0.09 to 0.03) | 0.355 | ||
| New stroke within 90 d | <65 y | 4/655 (0.61) | 4/594 (0.67) | 1.1 (0.28–4.43) | 0.890 | 1.11 (0.27–4.57) | 0.891 | 0.904 |
| ≥65 y | 7/815 (0.86) | 7/767 (0.91) | 1.06 (0.37–3.05) | 0.909 | 0.97 (0.33–2.85) | 0.959 | ||
| Death within 90 d | <65 y | 6/655 (0.92) | 2/594 (0.34) | 0.37 (0.07–1.82) | 0.219 | 0.47 (0.09–2.48) | 0.371 | 0.330 |
| ≥65 y | 10/815 (1.23) | 10/767 (1.3) | 1.06 (0.44–2.57) | 0.891 | 1.11 (0.45–2.72) | 0.817 | ||
| Safety outcomes | ||||||||
| Mucocutaneous hemorrhage | <65 y | 1/655 (0.15) | 0 | NA | NA | NA | NA | NA |
| ≥65 y | 1/815 (0.12) | 1/767 (0.13) | 1.06 (0.07–17.02) | 0.996 | 1.25 (0.07–22.08) | 0.877 | ||
| Organ hemorrhage | <65 y | 1/655 (0.15) | 1/594 (0.17) | 1.1 (0.07–17.67) | 0.945 | 1.18 (0.06–23.95) | 0.915 | NA |
| ≥65 y | 1/815 (0.12) | 0 | NA | NA | NA | NA | ||
| Intracranial hemorrhage | <65 y | 1/655 (0.15) | 1/594 (0.17) | 1.1 (0.07–17.67) | 0.945 | 1.22 (0.07–20.37) | 0.891 | NA |
| ≥65 y | 0 | 1/767 (0.13) | NA | NA | NA | NA | ||
| Symptomatic intracranial hemorrhage | <65 y | 1/655 (0.15) | 1/594 (0.17) | 1.1 (0.07–17.67) | 0.945 | 1.22 (0.07–20.37) | 0.891 | NA |
| ≥65 y | 0 | 0 | NA | NA | NA | NA | ||
| Asymptomatic intracranial hemorrhage | <65 y | 0 | 0 | NA | NA | NA | NA | NA |
| ≥65 y | 0 | 1/767 (0.13) | NA | NA | NA | NA | ||
| Any bleeding events | <65 y | 5/655 (0.76) | 5/594 (0.84) | 1.1 (0.32–3.83) | 0.877 | 1.13 (0.32–3.93) | 0.854 | 0.499 |
| ≥65 y | 2/815 (0.25) | 5/767 (0.65) | 2.67 (0.52–13.79) | 0.242 | 2.61 (0.5–13.79) | 0.258 | ||
| Adverse events | <65 y | 58/655 (8.85) | 56/594 (9.43) | 1.07 (0.73–1.58) | 0.726 | 1.08 (0.73–1.59) | 0.703 | 0.881 |
| ≥65 y | 67/815 (8.22) | 69/767 (9) | 1.1 (0.78–1.57) | 0.583 | 1.11 (0.78–1.57) | 0.579 | ||
| Serious adverse events | <65 y | 2/655 (0.31) | 2/594 (0.34) | 1.1 (0.16–7.86) | 0.922 | 1.12 (0.16–8.06) | 0.908 | 0.474 |
| ≥65 y | 6/815 (0.74) | 2/767 (0.26) | 0.35 (0.07–1.75) | 0.202 | 0.39 (0.08–1.98) | 0.256 | ||
Data are shown as % (n/N) or median (IQR). mRS, modified Rankin Scale; END, early neurological deterioration; NIHSS, National Institutes of Health Stroke Scale. Pint value means the p-value for interaction. Adjusted for prespecified covariates, including sex, history of diabetes, history of hypertension, NIHSS score at randomization, time from symptom onset to antiplatelet treatment, and stroke etiology. Scores on the modified Rankin Scale (mRS) for functional disability range from 0 (no symptoms) to 6 (death). END was defined as an increase of two points or more in the NIHSS score between baseline and 7 days, excluding any changes attributed to cerebral hemorrhage, hypoglycemia, cardiac complications, fever, or infection. * Bold values indicate p < 0.05.