Table 2.
Primary outcome events according to treatment groups
| Outcome events | Stratum 1*
|
Stratum 2
|
Total | Hazard ratio (95% CI)
|
|||||
|---|---|---|---|---|---|---|---|---|---|
| Standard anticoagulation | Low anticoagulation | Aspirin | Low anticoagulation | Aspirin | Standard v aspirin | Low v aspirin | |||
| Follow up: | |||||||||
| No of patients | 131 | 122 | 141 | 157 | 178 | 729 | |||
| No of patient years | 400.9 | 361.1 | 392.0 | 373.7 | 411.2 | 1938.9 | |||
| Mean (SD) follow up (years) | 3.1 (1.3) | 3.0 (1.3) | 2.8 (1.3) | 2.4 (1.2) | 2.3 (1.2) | 2.7 (1.2) | |||
| Range | 0.1-5.6 | 0.3-5.6 | 0.4-5.6 | 0.4-5.6 | 0.1-5.5 | 0.1-5.6 | |||
| Primary outcome event† (No (%/year)): | 10 (2) | 8 (2) | 12 (3) | 37 (10) | 41 (10) | 108 (5.5) | 0.78 (0.34 to 1.8) | 0.91 (0.61 to 1.4) | |
| Non-fatal stroke: | 3 | 4 | 4 | 14 | 17 | 42 (2.1) | 0.62 (0.10 to 3.7) | 0.94 (0.45 to 2.0) | |
| Ischaemic stroke, major | 2 | 1 | 3 | 11 | 10 | 27 (1.3) | 0.67 (0.11 to 4.1) | 0.99 (0.45 to 2.2) | |
| Ischaemic stroke, minor | 1 | 2 | 1 | 1 | 3 | 7 (0.4) | 0.81 (0.18 to 3.6) | ||
| Cerebral bleeding, major | 1 | 1 | 1 | 2 | 4 | 8 (0.4) | 0.80 (0.18 to 3.6) | ||
| Non-fatal systemic embolism | 1 | 2 | 1 | 1 | 5 | 8 (0.4) | 0.97 (0.06 to 15.6) | 0.18 (0.02 to 1.5) | |
| Major haemorrhage, extracranial | 0 | 0 | 0 | 4 | 5 | 13 (0.7) | 0.96 (0.06 to 15.4) | 1.1 (0.36 to 3.4) | |
| Vascular death: | 5 (1) | 2 (1) | 6 (2) | 18 (5) | 14 (3) | 45 (2.3) | 0.76 (0.23 to 2.5) | 1.1 (0.58 to 2.0) | |
| Myocardial infarction | 1 | 0 | 1 | 0 | 4 | 6 (0.3) | |||
| Sudden death, observed | 0 | 1 | 1 | 3 | 1 | 6 (0.3) | |||
| Sudden death, unobserved | 3 | 1 | 3 | 7 | 5 | 19 (1.0) | |||
| Congestive heart failure | 1 | 0 | 1 | 8 | 4 | 14 (0.7) | |||
*
Standard anticoagulation: international normalised ratio 2.5-3.5; low anticoagulation: 1.1-1.6; aspirin=150 mg /day. †Primary outcome events are given according to whichever came first.