Table 1. Demographic and Clinical Characteristics of the Study Groups.
| Variable | Discovery Cohort | Replication Cohort | ||
|---|---|---|---|---|
| Cases (n = 31) |
Controls (n = 184) |
Cases (n = 40) |
Controlsa (n = 148) |
|
| Age, mean (SD), y | 60.1 (14.9) | 57.1 (15.7) | 55.6 (17.3) | 55.4 (17.1) |
| Weight, mean (SD), kg | 88.35 (22.4) | 91.89 (27.8) | 93.5 (13.6) | 96.27 (21.3) |
| Warfarin maintenance dose, mg/wk | 40.89 (20.4) | 46.07 (19.1) | 41.5 (16.2) | 44.6 (16.5) |
| INR at the time of bleed, mean (SD) | 2.67 (0.87) | 2.27 (0.83) | ||
| Sex, No. (%) | ||||
| Women | 26 (83.9) | 128 (69.6) | 27 (67.5) | 98 (66.2) |
| Men | 5 (16.1) | 56 (30.4) | 13 (32.5) | 50 (33.8) |
| Abnormal renal function, No. (%)b | 10 (32.3) | 27 (14.7) | 20 (50) | 40 (27) |
| HAS-BLED risk factors, No. (%)c | ||||
| Systolic blood pressure, >160 mm Hg uncontrolled | 8 (20) | 5 (3.4) | ||
| Abnormal renal functionb | 20 (50) | 40 (27) | ||
| Abnormal liver functiond | 5 (12.5) | 11 (7.4) | ||
| Stroke | 7 (17.5) | 37 (25) | ||
| Prior major bleeding | 27 (67.5) | 59 (40) | ||
| Age > 65 y | 18 (45) | 71 (48) | ||
| Antiplatelet agents or NSAIDs | 29 (72.5) | 93 (62.8) | ||
| 8 Alcoholic drinks/wk | 5 (12.5) | 30 (20.3) | ||
Abbreviations: HAS-BLED, hypertension, abnormal renal or liver function, stroke, bleeding history, labile international normalized ratio (INR), elderly, antiplatelet agents or nonsteroidal anti-inflammatory drugs (NSAIDs), or alcohol use.
Thirteen controls from the replication cohort failed genotyping, leading to decrease in controls to 148.
Abnormal renal function, defined as presence of chronic dialysis, renal transplantation, or serum creatinine ≥200 μmol/L (to convert creatinine from μmol/L to mg/dL, divide by 88.4).
Clinical details for HAS-BLED scheme were available only for the replication cohort.
Cirrhosis or bilirubin at more than 2 × normal or aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase more than 3 × normal.