TABLE 3.
Number of Stroke or Systemic Embolism and Major Bleeding by TTRs
| TTR < 46% | TTR 46%-60% | TTR 61%-72% | TTR ≥ 73% | Total | |
|---|---|---|---|---|---|
| Stroke or systemic embolism, total patients, n | 8,435 | 7,893 | 7,966 | 7,690 | 32,074 |
| Total stroke or systemic embolism events, n (%) | 419 (5.0) | 315 (3.9) | 269 (3.4) | 236 (3.1) | 1,239 (3.9) |
| Hemorrhagic stroke | 61 (0.7) | 42 (0.5) | 53 (0.7) | 39 (0.5) | 195 (0.6) |
| Ischemic stroke | 305 (3.6) | 220 (2.8) | 178 (2.2) | 167 (2.2) | 870 (2.7) |
| Systemic embolism | 53 (0.6) | 53 (0.7) | 38 (0.5) | 30 (0.4) | 174 (0.5) |
| Mean [SD] follow-up, days | 657 [615] | 1,137 [681] | 1,314 [677] | 1,253 [717] | 1,083 [722] |
| Number of stroke or systemic embolism events per 100 person-years | 2.76 | 1.27 | 0.94 | 0.89 | 1.30 |
| Adjusted HR (95% CI), N = 32,074a | 3.19 (2.71-3.77) | 1.31 (1.11-1.56) | 0.98 (0.82-1.17) | Reference | |
| Major bleeding, total patients, n | 8,575 | 7,414 | 7,353 | 7,670 | 31,012 |
| Total major bleeding events, n (%) | 2,083 (24.3) | 1,717 (23.2) | 1,594 (21.7) | 1,785 (23.3) | 7,179 (23.1) |
| Intracranial bleeding | 47 (0.5) | 44 (0.6) | 32 (0.4) | 25 (0.3) | 148 (0.5) |
| Gastrointestinal bleeding | 1,451 (16.9) | 1,147 (15.5) | 1,118 (15.2) | 1,247 (16.3) | 4,963 (16.0) |
| Other types of bleeding | 585 (6.8) | 526 (7.1) | 444 (6.0) | 513 (6.7) | 2,068 (6.7) |
| Mean [SD] follow-up, days | 558 [561] | 992 [660] | 1,171 [682] | 1,088 [712] | 938 [697] |
| Number of major bleeding events per 100 person-years | 15.91 | 8.52 | 6.76 | 7.81 | 9.01 |
| Adjusted HR (95% CI), N = 31,012b | 2.10 (1.96-2.24) | 1.05 (0.98-1.12) | 0.85 (0.79-0.91) | Reference |
aAdjusted for age; sex; race/ethnicity; warfarin start in 2 months; baseline conditions (myocardial infarction); baseline number of emergency visits/hospitalizations; baseline medication use (anti-arrythmic medication, heart rate control, periprocedural anticoagulation, and previous warfarin use); CHADS2 scores; and CCI scores.
bAdjusted for age; sex; race/ethnicity; warfarin start in 2 months; baseline conditions (malignancy, asthma, peripheral vascular disease, bleed, dementia, fall, and cardiac myopathy); CHADS2 scores; and CCI scores.
CCI = Charlson Comorbidity Index; CI = confidence interval; HR = hazard ratio; SD = standard deviation; TTR = time-in-therapeutic range.