Rates of bleeding events during extended oral anticoagulation in patients at high risk versus those not at high risk
| Variable . | All patients . | Modified ACCP . | Modified RIETE . | Modified VTE-BLEED . | Modified HAS-BLED . | Modified OBRI . | CHAP Model . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| High risk . | Non–high risk . | High risk . | Non–high risk . | High risk . | Non–high risk . | High risk . | Non–high risk . | High risk . | Non–high risk . | High risk . | Non–high risk . | ||
| Patients | 2516 (100) | 832 (35) | 1538 (65) | 16 (1) | 2497 (99) | 739 (30) | 1708 (70) | 183 (8) | 2242 (92) | 39 (2) | 2468 (98) | 586 (25) | 1730 (75) |
| Person-years | 7030 | 2169 | 4576 | 38 | 6986 | 1961 | 4901 | 444 | 6422 | 83 | 6929 | 1525 | 4974 |
| Major bleeding | |||||||||||||
| Events | 121 | 71 | 44 | 2 | 119 | 60 | 56 | 23 | 94 | 4 | 117 | 60 | 55 |
| Event rate per 100 person-years | 1.7 (1.4-2.1) | 3.3 (2.6-4.1) | 1.0 (0.7-1.3) | 5.3 (0.6-19.2) | 1.7 (1.4-2.0) | 3.1 (2.3-3.9) | 1.1 (0.9-1.5) | 5.2 (3.3-7.8) | 1.5 (1.2-1.8) | 4.8 (1.3-12.4) | 1.7 (1.4-2.0) | 3.9 (3.0-5.1) | 1.1 (0.8-1.4) |
| Hazard ratio | — | 3.3 (2.3-4.9) | 3.1 (0.7-12.8) | 2.8 (1.9-4.0) | 3.6 (2.3-5.7) | 2.8 (1.1-7.4) | 3.4 (2.4-5.0) | ||||||
| Intracranial bleeding | |||||||||||||
| Events | 20 | 12 | 8 | 0 | 20 | 17 | 3 | 6 | 14 | 1 | 19 | 12 | 8 |
| Event rate per 100 person-years | 0.3 (0.2-0.4) | 0.6 (0.3-1.0) | 0.2 (0.1-0.3) | 0.0 | 0.3 (0.2-0.4) | 0.9 (0.5-1.4) | 0.1 (0.01-0.2) | 1.4 (0.5-2.9) | 0.2 (0.1-0.4) | 1.2 (0.03-6.7) | 0.3 (0.2-0.4) | 0.8 (0.4-1.4) | 0.2 (0.1-0.3) |
| Fatal bleeding | |||||||||||||
| Events | 7 | 6 | 1 | 0 | 7 | 7 | 0 | 3 | 4 | 1 | 6 | 6 | 1 |
| Event rate per 100 person-years | 0.1 (0.04-0.2) | 0.3 (0.1-0.6) | 0.02 (0.0-0.1) | 0.0 | 0.1 (0.04-0.2) | 0.4 (0.1-0.7) | 0.0 | 0.7 (0.1-2.0) | 0.1 (0.02-0.2) | 1.2 (0.03-6.7) | 0.1 (0.03-0.2) | 0.4 (0.1-0.9) | 0.02 (0.0-0.1) |
| Case-fatality rate of major bleeding, % | 5.8 (2.3-11.9) | 8.5 (3.1-18.4) | 2.3 (0.1-12.7) | 0.0 | 5.9 (2.4-12.1) | 11.7 (4.7-24.0) | 0.0 | 13.0 (2.7-38.1) | 4.3 (1.2-10.9) | 25.0 (0.6-100.0) | 5.1 (1.9-11.2) | 10 (3.7-21.8) | 1.8 (0.1-10.1) |
| Variable . | All patients . | Modified ACCP . | Modified RIETE . | Modified VTE-BLEED . | Modified HAS-BLED . | Modified OBRI . | CHAP Model . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| High risk . | Non–high risk . | High risk . | Non–high risk . | High risk . | Non–high risk . | High risk . | Non–high risk . | High risk . | Non–high risk . | High risk . | Non–high risk . | ||
| Patients | 2516 (100) | 832 (35) | 1538 (65) | 16 (1) | 2497 (99) | 739 (30) | 1708 (70) | 183 (8) | 2242 (92) | 39 (2) | 2468 (98) | 586 (25) | 1730 (75) |
| Person-years | 7030 | 2169 | 4576 | 38 | 6986 | 1961 | 4901 | 444 | 6422 | 83 | 6929 | 1525 | 4974 |
| Major bleeding | |||||||||||||
| Events | 121 | 71 | 44 | 2 | 119 | 60 | 56 | 23 | 94 | 4 | 117 | 60 | 55 |
| Event rate per 100 person-years | 1.7 (1.4-2.1) | 3.3 (2.6-4.1) | 1.0 (0.7-1.3) | 5.3 (0.6-19.2) | 1.7 (1.4-2.0) | 3.1 (2.3-3.9) | 1.1 (0.9-1.5) | 5.2 (3.3-7.8) | 1.5 (1.2-1.8) | 4.8 (1.3-12.4) | 1.7 (1.4-2.0) | 3.9 (3.0-5.1) | 1.1 (0.8-1.4) |
| Hazard ratio | — | 3.3 (2.3-4.9) | 3.1 (0.7-12.8) | 2.8 (1.9-4.0) | 3.6 (2.3-5.7) | 2.8 (1.1-7.4) | 3.4 (2.4-5.0) | ||||||
| Intracranial bleeding | |||||||||||||
| Events | 20 | 12 | 8 | 0 | 20 | 17 | 3 | 6 | 14 | 1 | 19 | 12 | 8 |
| Event rate per 100 person-years | 0.3 (0.2-0.4) | 0.6 (0.3-1.0) | 0.2 (0.1-0.3) | 0.0 | 0.3 (0.2-0.4) | 0.9 (0.5-1.4) | 0.1 (0.01-0.2) | 1.4 (0.5-2.9) | 0.2 (0.1-0.4) | 1.2 (0.03-6.7) | 0.3 (0.2-0.4) | 0.8 (0.4-1.4) | 0.2 (0.1-0.3) |
| Fatal bleeding | |||||||||||||
| Events | 7 | 6 | 1 | 0 | 7 | 7 | 0 | 3 | 4 | 1 | 6 | 6 | 1 |
| Event rate per 100 person-years | 0.1 (0.04-0.2) | 0.3 (0.1-0.6) | 0.02 (0.0-0.1) | 0.0 | 0.1 (0.04-0.2) | 0.4 (0.1-0.7) | 0.0 | 0.7 (0.1-2.0) | 0.1 (0.02-0.2) | 1.2 (0.03-6.7) | 0.1 (0.03-0.2) | 0.4 (0.1-0.9) | 0.02 (0.0-0.1) |
| Case-fatality rate of major bleeding, % | 5.8 (2.3-11.9) | 8.5 (3.1-18.4) | 2.3 (0.1-12.7) | 0.0 | 5.9 (2.4-12.1) | 11.7 (4.7-24.0) | 0.0 | 13.0 (2.7-38.1) | 4.3 (1.2-10.9) | 25.0 (0.6-100.0) | 5.1 (1.9-11.2) | 10 (3.7-21.8) | 1.8 (0.1-10.1) |
Values presented as count (percentage) where applicable. Ranges in parentheses are 95% CIs.