Table 1. Baseline Characteristics of Patients With and Without Bleeding Events in the RE-LY Trial (Development Cohort).
Presented are baseline characteristics of individuals in the development cohort (RE-LY). Baseline characteristics were stratified by individuals who experienced a major bleeding event and those who did not during the study period. Only individuals in the dabigatran 150 mg twice daily arm of the trial were included. Individuals were followed for the duration of DOAC during the trial.
| Major Bleeding Outcome | No (N= 5298) |
Yes (N=386) |
|
|---|---|---|---|
| Mean Age, Years | 71.1 | 75.8 | |
| Female, % | 36.7% | 35.5% | |
| Race/Ethnicity | |||
| White | 69.0% | 73.6% | |
| Black | 0.9% | 1.6% | |
| Asian | 16.8% | 10.9% | |
| Other | 13.3% | 14.0% | |
| Mean CHA2DS2-VASc | 3.7 | 4.3 | |
| Mean HAS-BLED | 1.7 | 2.0 | |
| Creatinine Clearance, mL/min | ≥60 | 65.3% | 48.7% |
| 30-59 | 34.2% | 49.5% | |
| <30 | 0.4% | 1.8% | |
| Obesity (Body Mass Index ≥30 kg/m2) | 34.7% | 38.3% | |
| Diabetes | 22.5% | 32.6% | |
| Hypertension | 78.6% | 83.9% | |
| Prior Stroke, Transient Ischemic Attack, or Embolism | 21.7% | 26.7% | |
| Antiplatelet Use | |||
| Aspirin | 44.1% | 64.2% | |
| Dual Antiplatelet | 4.4% | 9.3% | |
| Nonsteroidal Anti-Inflammatory Drug | 64.4% | 78.8% | |
| Bleeding History | 6.5% | 7.8% | |
| Liver Disease | 1.2% | 0.5% | |
| Smoking History | 50.6% | 61.1% | |