Table 3.
Major outcomes during follow-up
| Univariate | Multivariable | |||||||
|---|---|---|---|---|---|---|---|---|
| Non-diabetics (n=1914) | Diabetics (n=1106) | HR (95% CI) | p value | HR (95% CI) | p value | |||
| N | Rate | N | Rate | |||||
| All stroke (ischemic & hemorrhage) | 137 | 1·9 | 140 | 3·7 | 1·9 (1·5, 2·4) | <0·0001 | 1·8 (1·4, 2·3) | <0·0001 |
| Ischemic stroke* | 116 | 1·6 | 127 | 3·3 | 2·0 (1·6, 2·6) | <0·0001 | 1·8 (1·4, 2·4) | <0·0001 |
| Intracranial hemorrhage* | 21 | 0·29 | 13 | 0·34 | 1·2 (0·6, 2·3) | 0·65 | 1·4 (0·6, 2·9) | 0·41 |
| Disabling/fatal stroke† | 42 | 0·58 | 47 | 1·2 | 2·1 (1·4, 3·2) | 0·0006 | 1·8 (1·2, 2·9) | 0·010 |
| Myocardial infarct | 37 | 0·49 | 39 | 0·96 | 2·0 (1·3, 3·1) | 0·0032 | 1·7 (1·0, 2·8) | 0·046 |
| Other thromboembolism‡ | 21 | 0·28 | 15 | 0·36 | 1·3 (0·7, 2·5) | 0·42 | 1·2 (0·5, 2·4) | 0·71 |
| Major vascular events§ | 179 | 2·5 | 169 | 4·5 | 1·8 (1·4, 2·2) | <0·0001 | 1·7 (1·3, 2·1) | <0·0001 |
| Deaths (all) | 102 | 1·3 | 105 | 2·5 | 1·9 (1·5, 2·5) | <0·0001 | 2·1 (1·6, 2·8) | <0·0001 |
| -Vascular | 36 | 0·48 | 41 | 0·99 | 2·1 (1·3, 3·3) | 0·0012 | 1·8 (1·1, 3·0) | 0·018 |
| -Non-vascular | 46 | 0·61 | 29 | 0·70 | 1·2 (0·7, 1·9) | 0·51 | 1·6 (0·9, 2·6) | 0·089 |
| -Uncertain | 20 | 0·26 | 35 | 0·84 | 3·3 (1·9, 5·7) | <0·0001 | 3·9 (2·1, 7·0) | <0·0001 |
| Major extracranial hemorrhages | 91 | 1·2 | 42 | 1·0 | 0·8 (0·6, 1·2) | 0·30 | 0·9 (0·6, 1·3) | 0·51 |
HR = hazard ratio yr = year; CNS = central nervous system; CI = confidence interval; TIA = transient ischemic attack; pt-yr = patient-year.
Time to first event in the specific category; rates are annualized. Total patient-years of exposure for the primary outcome (all strokes) were 5026 for those assigned to aspirin alone and 5114 for those assigned to clopidogrel plus aspirin.
Two strokes without neuroimaging were adjudicated as probable ischemic and included with ischemic strokes.
Of 81 total disabling/fatal strokes, 16 were fatal strokes, 65 were disabling based on Rankin score. Another 14 were unable to be classified and were excluded from these analyses. For non-disabling strokes, patients were censored at the time of their primary event for these analyses.
Other thromboembolism included venous thromboembolism (18 with dual antiplatelet, 10 with aspirin) and peripheral arterial embolism (2 with dual antiplatelet, 1 with aspirin).
Stroke, myocardial infarct, or vascular death.