Table 6.
Mean variables of patients with contraindication for OAC treatment reported in different registries.
| Registry | EWOLUTION Registry | Multicenter Amplatzer | Amulet Registry | Ii Iberian Registry | Italian Registry |
|---|---|---|---|---|---|
| Population (n) | n = 1025 | n = 1047 | n = 1088 | n = 598 | n = 613 |
| Mean age | 73.4 ± 8.9 | 75 ± 8 | 74 ± 8 | 75.4 ± 8.6 | 75.1 ± 8.0 |
| Follow up (months) | 12 | 13 | 12 | 22.9 | 20 |
| CHA2DS2-VASc score (mean ± SD) | 4.5 ± 1.6 | 4.5 ± 1.6 | 4.5 ± 1.6 | 4.4 ± 1.5 | 4.2 ± 1.5 |
| HAS-BLED score (mean ± SD) | 2.3 ± 1.2 | 3.1 ± 1.2 | 3.3 ± 1.1 | 3.4 ± 1.2 | 3.2 ± 1.1 |
| Rate of events per 100 patient-years | |||||
| Deaths | 9.8% | 4.3% | 8.4% | 7% | 7.4% |
| History of Stroke | 30.5% | 39% | 28% | 39% | 36.3% |
| History of major Bleeding |
31% | 47.7% | 72% | 46% | 41.6% |
| Observed vs. Expected | |||||
| Stroke | 1.1% vs. 7.2% (CHA2DS2-VASc) RRR, 83% |
1.8% vs. 5.62% (CHA2DS2-VASc) RRR, 59% |
2.9 vs. 6.7% (CHA2DS2-VASc) RRR, 57% |
1.6% vs. 8.5% (CHA2DS2-VASc) RRR, 81% |
2.9% vs. 8.6% (CHA2DS2-VASc) RRR, 66% |
| Major bleeding | 2.7% vs. 5% (HAS-BLED) RRR, 46% |
2.1% vs. 5.34% (HAS-BLED) RRR, 46% |
7.1% vs. 10.3% | 3.9% vs. 6.4% (HAS-BLED) RRR, 39% |
4.5% vs. 6.3% (HAS-BLED) RRR, 29% |
OAC: Oral anticoagulants; RRR: relative risk reduction; SD: standard deviation.