Table 3.
Comparison between aspirin and no aspirin groups in number (percentage) of patients with diabetes who experienced primary end points, secondary end points, and specific adverse events
| Variables | Aspirin (n=638) | No aspirin (n=638) | Effect estimate* (95% CI) | P value |
|---|---|---|---|---|
| Primary end points: | ||||
| Composite end point† | 116 (18.2) | 117 (18.3) | 0.98 (0.76 to 1.26) | 0.86 |
| Death from coronary heart disease or stroke | 43 (6.7) | 35 (5.5) | 1.23 (0.79 to 1.93) | 0.36 |
| Secondary end points: | ||||
| Death (any cause) | 94 (14.7) | 101 (15.8) | 0.93 (0.71 to 1.24) | 0.63 |
| Coronary heart disease death | 35 (5.5) | 26 (4.1) | 1.35 (0.81 to 2.25) | 0.24 |
| Stroke death | 8 (1.3) | 9 (1.4) | 0.89 (0.34 to 2.30) | 0.80 |
| Non-fatal myocardial infarction | 55 (8.6) | 56 (8.8) | 0.98 (0.68 to 1.43) | 0.93 |
| Non-fatal stroke | 29 (4.6) | 41 (6.4) | 0.71 (0.44 to 1.14) | 0.15 |
| Above ankle amputation for critical limb ischaemia | 11 (1.7) | 9 (1.4) | 1.23 (0.51 to 2.97) | 0.64 |
| Transient ischaemic attack | 14 (2.2) | 20 (3.1) | 0.70 (0.36 to 1.39) | 0.31 |
| Coronary artery bypass surgery | 10 (1.6) | 16 (2.5) | 0.62 (0.28 to 1.38) | 0.24 |
| Coronary artery angioplasty | 7 (1.1) | 8 (1.3) | 0.88 (0.32 to 2.43) | 0.81 |
| Development of angina | 70 (11.0) | 78 (12.2) | 0.90 (0.66 to 1.25) | 0.54 |
| Peripheral arterial bypass surgery | 7 (1.1) | 5 (0.8) | 1.41 (0.45 to 4.43) | 0.56 |
| Peripheral arterial angioplasty | 11 (1.7) | 13 (2.0) | 0.85 (0.38 to 1.89) | 0.68 |
| Development of critical limb ischaemia | 21 (3.3) | 19 (3.0) | 1.11 (0.60 to 2.06) | 0.75 |
| Development of claudication | 97 (15.2) | 107 (16.8) | 0.89 (0.68 to 1.18) | 0.42 |
| Adverse events: | ||||
| Malignancy | 53 (8.3) | 68 (10.7) | 0.76 (0.52 to 1.11) | 0.15 |
| Gastrointestinal bleeding | 28 (4.4) | 31 (4.9) | 0.90 (0.53 to 1.52) | 0.69 |
| Gastrointestinal symptoms, including dyspepsia | 73 (11.4) | 94 (14.7) | 0.77 (0.55 to 1.08) | 0.081 |
| Arrhythmia | 55 (8.6) | 47 (7.4) | 1.19 (0.79 to 1.78) | 0.41 |
| Allergy including skin rash | 72 (11.3) | 64 (10.0) | 1.14 (0.80 to 1.63) | 0.47 |
*Hazard ratios (aspirin v no aspirin) for primary and secondary end points and odds ratios (aspirin v no aspirin) for adverse events.
†Death from coronary heart disease or stroke, non-fatal myocardial infarction or stroke, or above ankle amputation for critical limb ischaemia.