Table 2.
Baseline patient characteristics and comorbidity of ARISTOTLE and ROCKET-AF stratified by polypharmacy status*
| ARISTOTLE (n = 18,201) | ROCKET-AF (n = 14,264) | |||
|---|---|---|---|---|
| Polypharmacy | No polypharmacy | Polypharmacy | No polypharmacy | |
| Patients (number) | 13,932 (77%) | 4269 (23%) | 9163 (64%) | 5101 (36%) |
| Age (years) | 70 (±9) | 68 (±10) | 73 (66, 78) | 71 (64, 77) |
| Male | 8831 (63%) | 2954 (69%) | 5444 (59%) | 3160 (62%) |
| BMI | 30 (±6) | 28 (±5) | 29 (26–33) | 27 (24–31) |
| CHADS2-score (≥ 3) | 4661 (34%) | 841 (20%) | 8085 (88%) | 4317 (85%) |
| Prior MI | 2287 (16%) | 298 (7%) | 1912 (21%) | 556 (11%) |
| Congestive heart failure | 4498 (32%) | 1043 (24%) | 6071 (66%) | 2837 (56%) |
| Prior stroke/TIA | 2249 (16%) | 577 (14%) | 4363 (48%) | 3447 (68%) |
| Peripheral artery disease | 781 (6%) | 103 (3%) | 651 (7%) | 188 (4%) |
| Diabetes mellitus | 4117 (30%) | 430 (10%) | 4509 (49%) | 1186 (23%) |
| Hypertension | 12,422 (89%) | 3494 (82%) | 8570 (94%) | 4340 (85%) |
| Creatinine clearance (mL/min) | 79 (±33) | 81 (±30) | 67 (51, 86) | 68 (54, 87) |
| COPD | 1718 (12%) | 232 (6%) | 1198 (13%) | 299 (6%) |
| Sleep apnea | 934 (7%) | 79 (2%) | – | – |
| Dementia | 87 (<1%) | 9 (<1%) | – | – |
| History of anemia | 1121 (8%) | 124 (3%) | – | – |
| Prior bleeding | 2580 (19%) | 460 (11%) | – | – |
| Osteoporosis | 887 (6%) | 83 (2%) | – | – |
| Falls within 1 year | 668 (5%) | 85 (2%) | – | – |
| Prior non-traumatic fracture | 908 (7%) | 166 (4%) | – | – |
| Medications | ||||
| Randomized to DOAC | 7022 (50.4%) | 2098 (49.1%) | 4590 (50%) | 2541 (50%) |
| ≥ 1 combined P-gp and CYP3A4 inhibitor | 2732 (24%) | 1128 (16%) | 1905 (21%) | 695 (14%) |
*Polypharmacy status for a patient was defined as 5 or more drugs in concomitant use at baseline