Table 3.
Baseline Characteristics of ROCKET AF Patients According to Major Bleeding Events
| Characteristic | Major Bleed n = 781 | No Major Bleed n = 13,455 | p Value |
|---|---|---|---|
| Age, yrs | 75 (69–80) | 73 (65–78) | <0.0001 |
| <65 yrs | 118 (15.1) | 3,170 (23.6) | |
| ≥65–74 yrs | 236 (30.2) | 4,497 (33.4) | <0.0001 |
| ≥75 yrs | 427 (54.7) | 5,788 (43.0) | |
|
| |||
| Female | 268 (34.3) | 5,377 (40.0) | 0.0017 |
|
| |||
| Race | 0.21 | ||
| White | 633 (81.1) | 11,225 (83.4) | |
| Black | 9 (1.1) | 170 (1.3) | |
| Asian | 114 (14.6) | 1,667 (12.4) | |
| Other | 25 (3.2) | 393 (2.9) | |
|
| |||
| Body mass index, kg/m2 | 28.0 (25.1–32.0) | 28.2 (25.1–32.0) | 0.42 |
|
| |||
| SBP, mm Hg | 130 (120–140) | 130 (120–140) | 0.12 |
|
| |||
| DBP, mm Hg | 80 (70–85) | 80 (70–84) | <0.0001 |
|
| |||
| AF type | |||
| Persistent/permanent | 638 (81.7) | 10,887 (80.9) | |
| Paroxysmal | 131 (16.8) | 2,380 (17.7) | 0.42 |
| Newly diagnosed | 12 (1.5) | 188 (1.4) | |
|
| |||
| Medical history | |||
| Hypertension | 705 (90.3) | 12,182 (90.5) | 0.78 |
| Diabetes mellitus | 334 (42.8) | 5,349 (39.8) | 0.05 |
| Coronary artery disease | 318 (40.7) | 5,142 (38.2) | 0.13 |
|
| |||
| Heart failure | 466 (59.7) | 8,428 (62.7) | 0.35 |
| LV dysfunction (<35% EF)* | 528 (84.9) | 8,431 (83.8) | 0.82 |
|
| |||
| Stroke/TIA | 361 (46.2) | 7,090 (52.7) | 0.0004 |
|
| |||
| Non-CNS systemic embolism | 20 (2.6) | 537 (4.0) | 0.052 |
|
| |||
| CHADS2 score | 3 (3–4) | 3 (3–4) | 0.52 |
|
| |||
| CHADS2 score >3 | 329 (42.1) | 5,846 (43.5) | 0.79 |
|
| |||
| Myocardial infarction | 152 (19.5) | 2,308 (17.2) | 0.033 |
|
| |||
| Peripheral arterial disease | 59 (7.6) | 777 (5.8) | 0.02 |
|
| |||
| COPD* | 111 (14.2) | 1,382 (10.3) | <0.0001 |
|
| |||
| Liver disease | 38 (4.9) | 708 (5.3) | 0.62 |
|
| |||
| Alcohol use* | 277 (35.5) | 4,767 (35.4) | 0.43 |
|
| |||
| Current/prior smoking* | 314 (40.2) | 4,467 (33.2) | 0.0001 |
|
| |||
| Prior GI bleeding | 61 (7.8) | 438 (3.3) | <0.0001 |
|
| |||
| Anemia (hemoglobin <13 g/dl in men, <12 g/dl in women)* | 194 (25.1) | 1,782 (13.5) | <0.0001 |
|
| |||
| Creatinine clearance, ml/min/1.73 m2 | 63 (49–82) | 68 (52–87) | <0.0001 |
|
| |||
| Prior ASA use | 330 (42.3) | 4,864 (36.2) | <0.0001 |
|
| |||
| Prior vitamin K antagonist use | 519 (66.5) | 8,370 (62.2) | 0.018 |
Values are median (25th–75th percentiles) or n (%).
Data not available: left ventricular (LV) dysfunction status: n = 3,557; chronic obstructive pulmonary disease (COPD): n = 6; alcohol use: n = 1; smoking: n = 3; and anemia: n = 270.
AF = atrial fibrillation; ASA = acetylsalicylic acid; CHADS2 = congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke, transient ischemic attack (TIA), or noncentral nervous system thromboembolism (doubled); CNS = central nervous system; DBP = diastolic blood pressure; EF = ejection fraction; GI = gastrointestinal; ROCKET AF = Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; SBP = systolic blood pressure; TIA = transient ischemic attack.