| Phase II N = 1,018 | Phase III N = 1,911 | Standardized difference |
---|---|---|---|
Age, mean (SD), yrs | 67.5 (11.6) | 66.8 (11.1) | –0.0658 |
Age group, yrs, n (%) | Â | Â | Â |
 < 65 | 393 (38.6) | 758 (39.7) | 0.0217 |
 65 to < 75 | 308 (30.3) | 647 (33.9) | 0.0772 |
 75 to < 80 | 157 (15.4) | 280 (14.7) | −0.0216 |
 80 to < 85 | 115 (11.3) | 163 (8.5) | −0.0927 |
 ≥ 85 | 45 (4.4) | 63 (3.3) | −0.0584 |
Female, n (%) | 457 (44.9) | 839 (43.9) | −0.0199 |
BMI*, mean (SD), kg/m2 | 24.73 (3.9) | 24.73 (3.4) | −0.0006 |
History of hypertension, n (%) | 660 (64.8) | 1259 (65.9) | 0.0220 |
Coronary artery disease, n (%) | 363 (35.7) | 605 (31.7) | −0.0847 |
Congestive heart failure, n (%) | 306 (30.1) | 491 (25.7) | –0.0975 |
Diabetes mellitus, n (%) | 203 (19.9) | 440 (23.0) | 0.0751 |
Myocardial infarction, n (%) | 119 (11.7) | 181 (9.5) | −0.0722 |
Chronic GI disease, n (%) | 63 (6.2) | 141 (7.4) | 0.0473 |
Previous stroke, n (%) | 115 (11.3) | 250 (13.1) | 0.0546 |
 Ischemic stroke, n (%) | 54 (5.3) | 215 (11.3) | 0.2171 |
 Hemorrhagic stroke, n (%) | 2 (0.2) | 13 (0.7) | 0.0733 |
 Transient ischemic attack, n (%) | 22 (2.2) | 47 (2.5) | 0.0199 |
Prior interventions in AF, n (%) | Â | Â | Â |
 Cardioversion | 139 (13.7) | 367 (19.2) | 0.1502 |
 Cardiac ablation | 79 (7.8) | 244 (12.8) | 0.1656 |
Previous bleeding, n (%) | 23 (2.3) | 51 (2.7) | 0.0264 |
CKD, n (%), CrCl < 60 mL/min | 269 (26.4) | 442 (23.1) | −0.0764 |
CHA2DS2-VASc score, mean (SD) | 3 (1.6) | 2.9 (1.6) | −0.0443 |
CHA2DS2-VASc score class, n (%) | Â | Â | Â |
 Low (score = 1 for females) | 44 (4.3) | 95 (5.0) | 0.0308 |
 Moderate (score = 1 for males, 2 for females) | 265 (26.0) | 496 (26.0) | −0.0017 |
 High (score ≥ 2 for males, ≥ 3 for females) | 709 (69.6) | 1320 (69.1) | −0.0124 |
HAS-BLED score, mean (SD) | 1.6 (1.1) | 1.6 (1.1) | −0.0554 |
HAS-BLED score class, n (%) | Â | Â | Â |
 Low (score < 3) | 681 (66.9) | 1471 (77.0) | 0.2258 |
 High (score ≥ 3) | 176 (17.3) | 336 (17.6) | 0.0077 |
 Missing | 161 (15.8) | 104 (5.4) | −0.3414 |
Type of AF, n (%) | Â | Â | Â |
 Paroxysmal | 613 (60.2) | 1206 (63.1) | 0.0595 |
 Persistent | 392 (38.5) | 648 (33.9) | −0.0958 |
 Permanent | 13 (1.3) | 57 (3.0) | 0.1183 |
Categorization of AF, n (%) | Â | Â | Â |
 Symptomatic | 231 (22.7) | 723 (37.8) | 0.3342 |
 Minimally symptomatic | 519 (51.0) | 819 (42.9) | –0.1634 |
 Asymptomatic | 268 (26.3) | 369 (19.3) | –0.1678 |