Table 2.
Consistent adherence | Early discontinuation | Gradual decline | |||||||
---|---|---|---|---|---|---|---|---|---|
Total | First 12 mo | After 12 mo | Total | First 12 mo | After 12 mo | Total | First 12 mo | After 12 mo | |
Thromboembolic events* | |||||||||
Total patient, N | 16 111 | 16 111 | 8077 | 2008 | 2008 | 1339 | 801 | 801 | 793 |
Total person‐years (PY) | 21 259 | 11 943 | 9316 | 3305 | 1809 | 1496 | 1874 | 801 | 1073 |
Total events, N | 299 | 136 | 83 | 59 | 18 | 25 | 18 | … | 13 |
Total event rates per 100 PY | 1.41 | 1.14 | 0.89 | 1.78 | 1.00 | 1.67 | 0.96 | … | 1.21 |
Ischemic stroke, N | 279 | 130 | 77 | 55 | 18 | 21 | 17 | … | 12 |
Ischemic stroke, rates | 1.31 | 1.10 | 0.83 | 1.66 | 1.00 | 1.40 | 0.91 | … | 1.12 |
Systemic embolism, N | 24 | 9 | 6 | 4 | … | 4 | 2 | … | 2 |
Systemic embolism, rates | 0.11 | 0.08 | 0.06 | 0.12 | … | 0.27 | 0.11 | … | 0.19 |
Major bleed events † | |||||||||
Total patient, N | 16 167 | 16 167 | 8102 | 1957 | 1957 | 1309 | 816 | 816 | 806 |
Total PY | 21 323 | 11 983 | 9340 | 3212 | 1764 | 1448 | 1904 | 816 | 1088 |
Total events, N | 312 | 142 | 80 | 20 | 7 | 9 | 10 | 1 | 7 |
Total event rates per 100 PY | 1.46 | 1.19 | 0.86 | 0.62 | 0.40 | 0.62 | 0.53 | 0.12 | 0.64 |
ICH, N | 23 | 11 | 7 | 3 | … | 2 | 2 | 1 | 1 |
ICH, rates | 0.11 | 0.09 | 0.07 | 0.09 | … | 0.14 | 0.11 | 0.12 | 0.09 |
GI bleed, N | 271 | 119 | 72 | 16 | 6 | 7 | 8 | … | 6 |
GI bleed, rates | 1.27 | 0.99 | 0.77 | 0.50 | 0.34 | 0.48 | 0.42 | … | 0.55 |
Other bleed, N | 29 | 17 | 3 | 1 | 1 | … | … | … | … |
Other bleed, rates | 0.14 | 0.14 | 0.03 | 0.03 | 0.06 | … | … | … | … |
… no observation. GI indicates gastrointestinal; and ICH, intracranial hemorrhage.
Patients were followed from the index date (first DOAC prescription) until the thromboembolic event, death, disenrollment from the health plan, switching from DOAC therapy to warfarin, or study end date (December 31, 2018), whichever occurred first. The percentages of switch to warfarin were 8.6%, 6.3%, and 3.8% for consistent adherence, early discontinuation, and gradual decline groups, respectively.
Major bleeding event was used as a censoring event instead of thromboembolic event.