Table 12:
Event Rates, Treatment Effects, and Severity: Major Bleeds
| Baseline Risk of Major Bleeds | |||
|---|---|---|---|
| HAS-BLED Score | Annual Probability of Event | Standard Error | Source |
| 0 | 0.000 | 0.0074a | Friberg et al, 201250 |
| 1 | 0.011 | 0.0074 | Friberg et al, 201250 |
| 2 | 0.021 | 0.0077 | Friberg et al, 201250 |
| 3 | 0.031 | 0.0011 | Friberg et al, 201250 |
| 4 | 0.047 | 0.0023 | Friberg et al, 201250 |
| 5 | 0.070 | 0.0077 | Friberg et al, 201250 |
| 6 | 0.145 | 0.0408 | Friberg et al, 201250 |
| 7 | 0.228 | 0.2575 | Friberg et al, 201250 |
| Treatment Effects | |||
| Intervention:Comparator | Odds Ratio | Standard Error | Source |
| Warfarin:aspirin | 1.90 | 0.2942 | Aguilar et al, 200753 |
| LAAC device:warfarin | 0.95 | 0.2011 | FDA, 201555 |
| Apixaban: warfarin | 0.69 | 0.0738 | ARISTOTLE, Granger et al, 201116 |
| Dabigatran 110 mg:warfarin | 0.80 | 0.0773 | RE-LY, Connolly et al, 200915 |
| Dabigatran 150 mg:warfarin | 0.93 | 0.0744 | RE-LY, Connolly et al, 200915 |
| Rivaroxaban:warfarin | 1.03 | 0.0736 | ROCKET AF, Patel et al, 201117 |
| Severity of Major Bleeds | |||
| Severity | Proportion | Standard Error | Source |
| Proportion of major bleeds that are: | |||
| Fatal | 0.080 | 0.0232 | Walraven et al, 200258 |
| Occurrence of Minor Bleeds Relative to Major Bleeds | |||
| Relative Risk | Standard Error | Source | |
| Minor bleed:major bleed | 2.28 | 0.4552 | De Caterina et al, 201057 |
Abbreviations: HAS-BLED, Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratios (INRs), Elderly, Drugs or alcohol; LAAC device, left atrial appendage closure device with delivery system.
Standard deviation assumed same as HAS-BLED score of one.