Table 3.
Demographic and clinical characteristics of patients with GI bleeding in both groups.
| Characteristics of patients with GI bleeding | Rivaroxaban | Warfarin | p value |
|---|---|---|---|
| (N = 7) | (N = 15) | ||
| GI bleeding events | 7/147 (4.76%) | 15 (9.80%) | 0.094 |
|
| |||
| GI bleeding events with high dose | 7/87 (8.01%) | 15 (9.80%) | 0.65 |
|
| |||
| Mean age ± SD | 72.14 ± 15.40 | 75.80 ± 11.38 | 0.4801 |
|
| |||
| Gender | |||
| Female | 2 (28.57%) | 7 (46.67%) | 0.4214 |
| Male | 5 (71.43%) | 8 (53.33%) | |
|
| |||
| Ethnic group | |||
| White | 6 (85.71%) | 13 (86.67%) | 0.9517 |
| AA | 1 (14.29%) | 1 (6.67%) | |
| Others | 0 | 1 (6.67%) | |
|
| |||
| Indication for drug | |||
| AF | 5 (71.43%) | 10 (66.67%) | 0.8233 |
| VTE treatment | 1 (14.29%) | 5 (33.33%) | |
| VTE prophylaxis | 1 (14.29%) | 0 | |
| Other | 0 | 0 | |
|
| |||
| Prophylactic dose | 0 | NA | |
|
| |||
| Therapeutic doses | 7 | NA | |
|
| |||
| Mean duration being on drug (days) ± SD | 29.00 ± 38.03 | 163.87 ± 143.5 | 0.0239† |
|
| |||
| Duration ≤40 days | 5 (71.43%) | 5 (33.33%) | 0.3770 |
|
| |||
| Concomitant with aspirin | 4 (57.14%) | 7 (46.67%) | 0.6471 |
|
| |||
| Concomitant with thienopyridine | 3 (42.86%) | 4 (26.67%) | 0.4476 |
|
| |||
| Dual antiplatelet agents | 2 (28.57%) | 3 (20%) | 0.655 |
|
| |||
| Concomitant with NSAIDs | 1 (14.29%) | 0 | 0.1341 |
|
| |||
| Hb < 12 | 3 (42.86%) | 7 (46.67%) | 0.8673 |
|
| |||
| Cr > 1.5 | 1 (14.29%) | 2 (13.33%) | 0.9517 |
|
| |||
| GFR ≤ 30 | 0 (0%) | 0 (0%) | NA |
|
| |||
| ALT > 40 | 1 (14.29%) | 2 (13.33%) | 0.9517 |
|
| |||
| BMI | |||
| <18.5 | 0 | 0 (0%) | 0.899 |
| 18.5–24.9 | 3 (42.86%) | 6 (40%) | |
| >25 | 4 (57.14%) | 9 (60%) | |
|
| |||
| Previous GI bleeding | 2 (28.57%) | 1 (6.67%) | 0.1632 |
|
| |||
| Upper GI tract | 3 (42.86%) | 6 (40%) | 0.899 |
|
| |||
| Lower GI tract | 4 (57.14%) | 5 (33.33%) | 0.29 |
|
| |||
| Occult GI bleeding | 0 (0%) | 4 (26.67%) | 0.1309 |
|
| |||
| Death related to GI bleeding | 0 (0%) | 0 (0%) | NA |
AA: African American, AF: atrial fibrillation, ALT: alanine aminotransferase, BMI: body mass index, Cr: creatinine, GFR: glomerular filtration rate, GI: gastrointestinal, Hb: hemoglobin, NSIADs: nonsteroidal anti-inflammatory drugs, and VTE: venous thromboembolism events. †Signifying statistical significant values.