Table 2.
Baseline characteristics of patients, separated according to treatment assignment and whether study medication was interrupted preprocedure
| Characteristic | Any interruption | No interruption | P* | ||||
|---|---|---|---|---|---|---|---|
| Overall (n = 3930) | Apixaban (n = 1960) | Warfarin (n = 1970) | Overall (n = 1509) | Apixaban (n = 741) | Warfarin (n = 768) | ||
| Age, median (25th, 75th), y | 71 (65, 77) | 71 (65, 77) | 71 (64, 77) | 71 (65, 77) | 72 (65, 77) | 71 (65, 77) | .44 |
| Female sex, no. (%) | 1209 (30.8) | 598 (30.5) | 611 (31.0) | 488 (32.3) | 237 (32.0) | 251 (32.7) | .26 |
| Region, no. (%) | <.0001 | ||||||
| North America | 1623 (41.3) | 798 (40.7) | 825 (41.9) | 525 (34.8) | 262 (35.4) | 263 (34.2) | |
| Latin America | 579 (14.7) | 286 (14.6) | 293 (14.9) | 163 (10.8) | 74 (10.0) | 89 (11.6) | |
| Europe | 1319 (33.6) | 661 (33.7) | 658 (33.4) | 615 (40.8) | 304 (41.0) | 311 (40.5) | |
| Asian Pacific | 409 (10.4) | 215 (11.0) | 194 (9.8) | 206 (13.7) | 101 (13.6) | 105 (13.7) | |
| Race, no. (%) | .003 | ||||||
| White | 3569 (90.8) | 1765 (90.1) | 1804 (91.6) | 1322 (87.6) | 653 (88.1) | 669 (87.1) | |
| Black | 43 (1.1) | 28 (1.4) | 15 (0.8) | 16 (1.1) | 6 (0.8) | 10 (1.3) | |
| Asian | 284 (7.2) | 148 (7.6) | 136 (6.9) | 150 (9.9) | 72 (9.7) | 78 (10.2) | |
| Other | 34 (0.9) | 19 (1.0) | 15 (0.8) | 21 (1.4) | 10 (1.3) | 11 (1.4) | |
| Systolic blood pressure, median (25th, 75th), mm Hg | 130 (120, 140) | 130 (120, 140) | 130 (120, 140) | 130 (120, 140) | 130 (120, 140) | 130 (120, 140) | .87 |
| Weight, median (25th, 75th), kg | 85 (73, 99) | 85 (73, 99) | 85 (74, 100) | 83 (72, 96) | 83 (72, 96) | 83 (71, 96) | .0004 |
| Prior myocardial infarction, no. (%) | 614 (15.6) | 316 (16.1) | 298 (15.1) | 244 (16.2) | 117 (15.8) | 127 (16.5) | .62 |
| Prior clinically relevant or spontaneous bleeding, no. (%) | 871 (22.2) | 434 (22.1) | 437 (22.2) | 372 (24.7) | 179 (24.2) | 193 (25.1) | .05 |
| History of fall within previous year, no. (%) | 244 (6.8) | 120 (6.7) | 124 (6.9) | 107 (7.7) | 56 (8.1) | 51 (7.2) | .26 |
| Type of atrial fibrillation, no. (%) | .14 | ||||||
| Paroxysmal | 699 (17.8) | 335 (17.1) | 364 (18.5) | 243 (16.1) | 117 (15.8) | 126 (16.4) | |
| Persistent or permanent | 3229 (82.2) | 1623 (82.9) | 1606 (81.5) | 1266 (83.9) | 624 (84.2) | 642 (83.6) | |
| Qualifying risk factors | |||||||
| Age ≥75 y, no. (%) | 1392 (35.4) | 694 (35.4) | 698 (35.4) | 555 (36.8) | 288 (38.9) | 267 (34.8) | .60 |
| Prior stroke, TIA or systemic embolism, no. (%) | 701 (17.8) | 344 (17.6) | 357 (18.1) | 322 (21.3) | 150 (20.2) | 172 (22.4) | .003 |
| Heart failure or reduced LVEF, no. (%) | 1131 (28.8) | 565 (28.8) | 566 (28.7) | 480 (31.8) | 226 (30.5) | 254 (33.1) | .03 |
| Diabetes, no. (%) | 1079 (27.5) | 527 (26.9) | 552 (28.0) | 402 (26.6) | 214 (28.9) | 188 (24.5) | .55 |
| Hypertension requiring treatment, no. (%) | 3471 (88.3) | 1734 (88.5) | 1737 (88.2) | 1285 (85.2) | 628 (84.8) | 657 (85.5) | .002 |
| CHADS2, mean (SD) | 2.1 (1.1) | 2.1 (1.1) | 2.1 (1.1) | 2.2 (1.1) | 2.2 (1.1) | 2.2 (1.2) | .006 |
| CHADS2 score, no. (%) | .004 | ||||||
| ≤1 | 1363 (34.7) | 682 (34.8) | 681 (34.6) | 509 (33.7) | 251 (33.9) | 258 (33.6) | |
| 2 | 1437 (36.6) | 724 (36.9) | 713 (36.2) | 500 (33.1) | 242 (32.7) | 258 (33.6) | |
| ≥3 | 1130 (28.8) | 554 (28.3) | 576 (29.2) | 500 (33.1) | 248 (33.5) | 252 (32.8) | |
| Medications at time of randomization, no. (%) | |||||||
| ACE inhibitor or ARB | 2763 (70.8) | 1379 (70.9) | 1384 (70.8) | 1022 (68.3) | 501 (67.9) | 521 (68.6) | .07 |
| Amiodarone | 383 (9.8) | 183 (9.4) | 200 (10.2) | 134 (9.0) | 62 (8.4) | 72 (9.5) | .33 |
| β-Blocker | 2556 (65.5) | 1279 (65.8) | 1277 (65.3) | 926 (61.9) | 446 (60.4) | 480 (63.2) | .01 |
| Aspirin | 1302 (33.1) | 669 (34.1) | 633 (32.1) | 467 (30.9) | 226 (30.5) | 241 (31.4) | .12 |
| Clopidogrel | 84 (2.1) | 38 (1.9) | 46 (2.3) | 24 (1.6) | 11 (1.5) | 13 (1.7) | .20 |
| Digoxin | 1110 (28.5) | 530 (27.2) | 580 (29.7) | 464 (31.0) | 218 (29.5) | 246 (32.4) | .07 |
| Calcium blocker | 1389 (35.6) | 664 (34.1) | 725 (37.1) | 527 (35.2) | 260 (35.2) | 267 (35.2) | .78 |
| Statin | 1952 (50.0) | 957 (49.2) | 995 (50.9) | 707 (47.2) | 348 (47.2) | 359 (47.3) | .06 |
| Nonsteroidal anti-inflammatory agent | 510 (13.1) | 241 (12.4) | 269 (13.8) | 207 (13.8) | 100 (13.6) | 107 (14.1) | .46 |
| Gastric antacid drugs | 979 (25.1) | 476 (24.5) | 503 (25.7) | 362 (24.2) | 183 (24.8) | 179 (23.6) | .49 |
| Renal function, no. (%) | .11 | ||||||
| Normal (80 mL/min) | 1635 (41.6) | 801 (40.9) | 834 (42.3) | 602 (39.9) | 288 (38.9) | 314 (40.9) | |
| Mild impairment (>50-80 mL/min) | 1690 (43.0) | 864 (44.1) | 826 (41.9) | 633 (41.9) | 313 (42.2) | 320 (41.7) | |
| Moderate impairment (>30-50 mL/min) | 546 (13.9) | 267 (13.6) | 279 (14.2) | 249 (16.5) | 128 (17.3) | 121 (15.8) | |
| Severe impairment (≤30 mL/min) | 47 (1.2) | 22 (1.1) | 25 (1.3) | 18 (1.2) | 7 (0.9) | 11 (1.4) | |
ACE, angiotensin-converting enzyme; LVEF, left ventricular ejection fraction; SD, standard deviation; TIA, transient ischemic attack.
*
P value compares overall any interruption vs overall no interruption.