Skip to main content
. 2021 Oct 29;10(21):e021601. doi: 10.1161/JAHA.121.021601

Table 2.

Thromboembolism and Major Bleeding Stratified by Long‐Term Adherence Trajectories

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.