Table 3.
Additional study populations: cumulative 1-year incidences of acute liver injury and hazard ratios for each type of NOAC compared to VKA, in patients with prior liver disease and in those with a history of chronic alcoholism.
| N patients | N events | Follow-up in days (mean ± SD) | Crude cumulative 1-year incidence with 95% CI (per 10,000) | Cumulative 1-year incidence with 95% CI after IPTW* (per 10,000) | Crude HR with 95% CI | HR after IPTW with 95% CI | |
|---|---|---|---|---|---|---|---|
| Patients with prior liver disease (N = 12,961) | |||||||
| Hospitalised acute liver injury | |||||||
| VKA | 7884 | 63 | 328 ± 84 | 86.2 (67.4–110.2) |
Dabigatran: 85.3 (68.3–102.3) Rivaroxaban: 85.4 (68.7–102.0) Apixaban: 84.0 (67.6–100.3) |
Reference | Reference |
| Dabigatran | 1120 | 7 | 342 ± 66 | 65.3 (31.2–136.6) | 109.9 (11.7–208.0) | 0.76 (0.35–1.65) | 1.33 (0.72–2.45) |
| Rivaroxaban | 2441 | 8 | 342 ± 65 | 33.9 (17.0–67.7) | 41.1 (14.0–68.3) | 0.40 (0.19–0.83) | 0.49 (0.25–0.96) |
| Apixaban | 1516 | 4 | 343 ± 64 | 27.5 (10.3–73.1) | 28.4 (4.6–52.1) | 0.32 (0.12–0.87) | 0.34 (0.12–0.93) |
| Elevation of transaminases (proxy, ancillary outcome) | |||||||
| VKA | 7884 | 21 | 314 ± 100 | 839.7 (778.6–905.4) |
Dabigatran: 836.3 (787.3–885.3) Rivaroxaban: 827.9 (779.3–876.8) Apixaban: 834.6 (785.5–883.7) |
Reference | Reference |
| Dabigatran | 1120 | 67 | 330 ± 84 | 620.3 (491.4–781.5) | 615.2 (437.6–792.7) | 0.73 (0.57–0.94) | 0.72 (0.56–0.93) |
| Rivaroxaban | 2441 | 153 | 329 ± 86 | 647.2 (555.0–754.1) | 615.6 (533.2–709.0) | 0.77 (0.64–0.92) | 0.74 (0.62–0.89) |
| Apixaban | 1516 | 97 | 329 ± 84 | 661.9 (545.7–801.8) | 678.6 (531.5–825.7) | 0.78 (0.63–0.97) | 0.80 (0.65–1.00) |
| Patients with a history of chronic alcoholism (N = 13,173) | |||||||
| Hospitalised acute liver injury | |||||||
| VKA | 7779 | 48 | 334 ± 77 | 65.5 (49.4–86.8) |
Dabigatran: 62.1 (49.0–75.3) Rivaroxaban: 59.6 (46.5–72.7) Apixaban: 61.8 (49.2–74.4) |
Reference | Reference |
| Dabigatran | 1317 | 2 | 342 ± 65 | 95.2 (54.1–167.0) | 174.2 (51.8–296.6) | 1.45 (0.77–2.73) | 2.86 (1.73–4.75) |
| Rivaroxaban | 2524 | 5 | 344 ± 62 | 20.4 (8.5–48.9) | 35.9 (4.5–67.4) | 0.31 (0.13–0.79) | 0.61 (0.29–1.26) |
| Apixaban | 1553 | 3 | 347 ± 55 | 19.7 (6.4–61.0) | 8.6 (0.7–16.5) | 0.30 (0.09–0.97) | 0.14 (0.03–0.80) |
| Elevation of transaminases (proxy, ancillary outcome) | |||||||
| VKA | 7779 | 402 | 325 ± 88 | 546.6 (496.9–601.1) |
Dabigatran: 534.5 (493.2–575.6) Rivaroxaban: 527.9 (488.2–567.7) Apixaban : 536.0 (495.4–576.6) |
Reference | Reference |
| Dabigatran | 1317 | 37 | 339 ± 69 | 295.8 (215.2–406.1) | 299.1 (153.8–444.4) | 0.52 (0.37–0.73) | 0.54 (0.38–0.75) |
| Rivaroxaban | 2524 | 111 | 336 ± 75 | 456.8 (380.8–547.7) | 565.4 (448.1–682.7) | 0.83 (0.67–1.02) | 1.07 (0.88–1.30) |
| Apixaban | 1553 | 80 | 338 ± 70 | 531.6 (429.2–657.5) | 569.5 (436.4–702.5) | 0.96 (0.76–1.23) | 1.06 (0.84–1.34) |
*Calculated for each of the three comparisons.
CI confidence interval, HR hazard ratio, IPTW inverse probability of treatment weighting, NOAC non-vitamin K antagonist oral anticoagulant, SD standard deviation, VKA vitamin K antagonist.