TABLE 1.
Baseline characteristics of the intention‐to‐treat population
| Baseline characteristic | Rivaroxaban N = 4008 | Warfarin N = 21 465 | SMD a |
|---|---|---|---|
| Age | |||
| Mean | 75.1 | 74.4 | 0.07 |
| SD b | 11.2 | 10.3 | |
| Gender no. (%) | |||
| Male | 2200 (54.9) | 12 107 (56.4) | 0.03 |
| Female | 1808 (45.1) | 9358 (43.6) | |
| BMI | 29.0 | 29.1 | 0.03 |
| Mean | 6.1 | 6.3 | |
| SD | |||
| Systolic BP | |||
| Mean | 132.4 | 132.8 | 0.02 |
| SD | 17.5 | 17.7 | |
| Diastolic BP | |||
| Mean | 76.6 | 77.1 | 0.04 |
| SD | 11.0 | 11.2 | |
| Patients met exclusion criteria; no (%) | 143 (3.6) | 1317 (6.1) | 0.12 |
| Previous use of anticoagulants (vitamin K or DOAC)/aspirin | 2296 (57.3) | 14 392 (67.0) | 0.20 |
| History of stroke, transient ischemic attack, or systemic embolism; no (%) | 337 (8.4) | 1884 (8.8) | 0.01 |
| CHA2DS2‐VASc risk score; no (%) | |||
| 0 | 165 (4.1) | 924 (4.3) | |
| 1 | 434 (10.8) | 2043 (9.5) | |
| 2 | 710 (17.7) | 3792 (17.7) | 0.05 |
| 3 | 1009 (25.2) | 5240 (24.4) | |
| 4 | 952 (23.8) | 5307 (24.7) | |
| 5 | 480 (12.0) | 2675 (12.5) | |
| ≥6 | 258 (6.4) | 1484 (6.9) | |
| Hypertension; no (%) | 2477 (61.8) | 13 583 (63.3) | 0.03 |
| Ischemic heart disease; no (%) | 818 (20.4) | 5224 (24.3) | 0.09 |
| Peripheral arterial disease; no (%) | 151 (3.8) | 907 (4.2) | 0.02 |
| Deep vein thrombosis/pulmonary embolism; no (%) | 98 (2.4) | 752 (3.5) | 0.06 |
| Congestive heart failure; no (%) | 417 (10.4) | 2786 (13.0) | 0.08 |
| Major bleeding; no (%) | 688 (17.2) | 3253 (15.2) | 0.05 |
| Diabetes mellitus; no (%) | 741 (18.5) | 3756 (17.5) | 0.03 |
| Chronic obstructive pulmonary disease; no (%) | 434 (10.8) | 2224 (10.4) | 0.02 |
| Kidney functions (reduced creatinine clearance); no (%) | |||
| Normal | 2029 (77.2) | 10 866 (76.6) | |
| Mildly impaired (80‐50 mL/min) | 395 (15.0) | 1924 (13.6) | 0.09 |
| Moderately impaired (50‐30 mL/min) | 183 (7.0) | 1182 (8.3) | |
| Severely impaired (<30 mL/min) | 22 (0.8) | 212 (1.5) | |
| Smoking history; no (%) | |||
| Never smokers | 1452 (36.4) | 8050 (37.6) | |
| Current smokers | 305 (11.1) | 2185 (10.2) | 0.03 |
| Former smokers | 2093 (52.5) | 11 152 (52.1) | |
| Liver functions (elevated liver enzymes); no (%) c | |||
| Normal liver functions | 3949 (98.5) | 21 236 (98.9) | |
| Mildly elevated (<3 ULN d ) | 57 (1.4) | 216 (1.0) | 0.04 |
| Cancer. no (%) | 1698 (42.4) | 8121(37.8) | 0.09 |
| GERD/Gastritis; no (%) | 993 (24.8) | 4836 (22.5) | 0.05 |
| Anemia; no (%) | 58 (1.4) | 266 (1.2) | 0.02 |
| Aspirin; no (%) | 1057 (26.4) | 7569 (35.3) | 0.19 |
| Antiarrhythmic agents; no (%) | 644 (16.1) | 4876 (22.7) | 0.17 |
| NSAIDs; no (%) | 191 (4.8) | 1558 (7.3) | 0.11 |
| Antiplatelets; no (%) | 1874 (46.8) | 12 670 (59.0) | 0.3 |
| SSRIs. no (%) | 313 (7.8) | 1477 (6.9) | 0.04 |
| Antidiabetics; no (%) | 524 (13.1) | 2749 (12.8) | 0.01 |
| Statins; no (%) | 1925 (48.0) | 10 594 (49.4) | 0.03 |
| Calcium channel blockers; no (%) | 1391 (34.7) | 7776 (36.2) | 0.03 |
| ACEIs/A2RBs; no (%) | 1911 (47.7) | 11 480 (53.5) | 0.12 |
| Diuretics; no (%) | 1337 (33.4) | 9173 (42.7) | 0.19 |
| Beta blockers; no (%) | 1744 (43.5) | 10 914 (50.8) | 0.15 |
| Centrally‐acting antihypertensive agents; no (%) | 35 (0.9) | 210 (1.0) | 0.01 |
| Alpha blockers; no (%) | 541 (13.5) | 3072 (14.3) | 0.02 |
| Antipsychotics; no (%) | 112 (2.8) | 649 (3.0) | 0.01 |
| Nitrates; no (%) | 158 (8.7) | 1034 (11.4) | 0.09 |
| Proton‐pump inhibitors/Histamine‐2 receptor antagonists; no (%) | 1490 (37.2) | 7489 (34.9) | 0.05 |
a
Standardized mean difference.
b
Standard deviation.
c
Data on patients with severely elevated liver functions (>3 ULN) are not provided in this table since CPRD policy precludes us from revealing data about small proportions for confidentiality purposes.
d
Upper limit of normal.