Table 1.
Baseline characteristics by sex and randomized treatment (ITT)
| Men | Women | ||||||
|---|---|---|---|---|---|---|---|
| Characteristics | Overall (N=1385) | Ablation (N=695) | Drug (N=690) | Overall (N=819) | Ablation (N=413) | Drug (N=406) | p-value* |
| Age | <.0001 | ||||||
| Median (Q1, Q3) | 66.5 (60.1, 70.9) | 66.6 (59.8, 71.2) | 66.4 (60.9, 70.8) | 69.4 (65.1, 73.7) | 69.4 (65.3, 74.0) | 69.4 (64.8, 73.3) | |
| N | 1385 | 695 | 690 | 819 | 413 | 406 | |
| Age - categories | <.0001 | ||||||
| <65 yrs | 568/1385 (41.0%) | 281/695 (40.4%) | 287/690 (41.6%) | 198/819 (24.2%) | 94/413 (22.8%) | 104/406 (25.6%) | |
| ≥ 65 to <75 yrs | 662/1385 (47.8%) | 343/695 (49.4%) | 319/690 (46.2%) | 468/819 (57.1%) | 234/413 (56.7%) | 234/406 (57.6%) | |
| ≥ 75 yrs | 155/1385 (11.2%) | 71/695 (10.2%) | 84/690 (12.2%) | 153/819 (18.7%) | 85/413 (20.6%) | 68/406 (16.7%) | |
| Race | 0.0520 | ||||||
| White | 1259/1384 (91.0%) | 629/694 (90.6%) | 630/690 (91.3%) | 766/816 (93.9%) | 389/413 (94.2%) | 377/403 (93.5%) | |
| Black or African American | 55/1384 (4.0%) | 31/694 (4.5%) | 24/690 (3.5%) | 22/816 (2.7%) | 8/413 (1.9%) | 14/403 (3.5%) | |
| Other | 70/1384 (5.1%) | 34/694 (4.9%) | 36/690 (5.2%) | 28/816 (3.4%) | 16/413 (3.9%) | 12/403 (3.0%) | |
| Minority: Hispanic or non-White | 158/1381 (11.4%) | 81/692 (11.7%) | 77/689 (11.2%) | 67/817 (8.2%) | 32/412 (7.8%) | 35/405 (8.6%) | 0.0154 |
| BMI(kg/m2) | 0.8296 | ||||||
| Median (Q1, Q3) | 30.0 (26.6, 34.3) | 30.0 (26.8, 33.9) | 30.1 (26.6, 34.6) | 30.1 (26.1, 35.2) | 30.0 (26.1, 34.9) | 30.5 (26.2, 35.6) | |
| N | 1370 | 685 | 685 | 800 | 401 | 399 | |
| AF Severity (CCS Class) | <.0001 | ||||||
| Class 0 | 160/1375 (11.6%) | 73/688 (10.6%) | 87/687 (12.7%) | 63/816 (7.7%) | 32/412 (7.8%) | 31/404 (7.7%) | |
| Class 1 | 246/1375 (17.9%) | 124/688 (18.0%) | 122/687 (17.8%) | 93/816 (11.4%) | 42/412 (10.2%) | 51/404 (12.6%) | |
| Class 2 | 433/1375 (31.5%) | 210/688 (30.5%) | 223/687 (32.5%) | 270/816 (33.1%) | 140/412 (34.0%) | 130/404 (32.2%) | |
| Class 3 | 457/1375 (33.2%) | 239/688 (34.7%) | 218/687 (31.7%) | 326/816 (40.0%) | 162/412 (39.3%) | 164/404 (40.6%) | |
| Class 4 | 79/1375 (5.7%) | 42/688 (6.1%) | 37/687 (5.4%) | 64/816 (7.8%) | 36/412 (8.7%) | 28/404 (6.9%) | |
| Heart function severity (NYHA Class) ≥ II | 433/1373 (31.5%) | 207/686 (30.2%) | 226/687 (32.9%) | 345/813 (42.4%) | 171/411 (41.6%) | 174/402 (43.3%) | <.0001 |
| Medical History | |||||||
| Hypertension (> 140/90 mmHg) | 1100/1385 (79.4%) | 538/695 (77.4%) | 562/690 (81.4%) | 676/818 (82.6%) | 338/413 (81.8%) | 338/405 (83.5%) | 0.0649 |
| Baseline left ventricular hypertrophy | 444/1025 (43.3%) | 223/540 (41.3%) | 221/485 (45.6%) | 218/619 (35.2%) | 111/324 (34.3%) | 107/295 (36.3%) | 0.0012 |
| Diabetes (Glucose ≥ 126 mg/dl) | 360/1385 (26.0%) | 179/695 (25.8%) | 181/690 (26.2%) | 201/818 (24.6%) | 101/413 (24.5%) | 100/405 (24.7%) | 0.4596 |
| Prior CVA or TIA | 129/1385 (9.3%) | 65/695 (9.4%) | 64/690 (9.3%) | 91/818 (11.1%) | 52/413 (12.6%) | 39/405 (9.6%) | 0.1708 |
| Coronary artery disease | 332/1385 (24.0%) | 160/695 (23.0%) | 172/690 (24.9%) | 92/818 (11.2%) | 48/413 (11.6%) | 44/405 (10.9%) | <.0001 |
| Sleep apnea | 372/1385 (26.9%) | 189/695 (27.2%) | 183/690 (26.5%) | 136/818 (16.6%) | 73/413 (17.7%) | 63/405 (15.6%) | <.0001 |
| Left ventricle ejection fraction ≤ 35 | 58/948 (6.1%) | 33/486 (6.8%) | 25/462 (5.4%) | 11/582 (1.9%) | 5/304 (1.6%) | 6/278 (2.2%) | 0.0001 |
| Co-morbidities | |||||||
| CHADS-VASc Score | <.0001 | ||||||
| Median (Q1, Q3) | 2.0 (1.0, 3.0) | 2.0 (1.0, 3.0) | 2.0 (1.0, 3.0) | 3.0 (3.0, 4.0) | 3.0 (3.0, 4.0) | 3.0 (3.0, 4.0) | |
| N | 1385 | 695 | 690 | 819 | 413 | 406 | |
| Arrhythmia History | |||||||
| Years since first onset of AF | 0.4818 | ||||||
| Median (Q1, Q3) | 1.0 (0.3, 3.9) | 1.0 (0.3, 4.2) | 1.0 (0.3, 3.7) | 1.2 (0.3, 3.8) | 1.1 (0.3, 3.8) | 1.4 (0.3, 3.9) | |
| N | 1373 | 690 | 683 | 812 | 410 | 402 | |
| Type of atrial fibrillation | |||||||
| Paroxysmal | 540/1385 (39.0%) | 276/695 (39.7%) | 264/690 (38.3%) | 406/818 (49.6%) | 194/413 (47.0%) | 212/405 (52.3%) | <.0001 |
| Persistent | 690/1385 (49.8%) | 338/695 (48.6%) | 352/690 (51.0%) | 352/818 (43.0%) | 186/413 (45.0%) | 166/405 (41.0%) | 0.0020 |
| Long-standing persistent | 155/1385 (11.2%) | 81/695 (11.7%) | 74/690 (10.7%) | 60/818 (7.3%) | 33/413 (8.0%) | 27/405 (6.7%) | 0.0032 |
| Prior direct current cardioversion of AF | 547/1384 (39.5%) | 267/694 (38.5%) | 280/690 (40.6%) | 262/818 (32.0%) | 131/413 (31.7%) | 131/405 (32.3%) | 0.0004 |
| Current or past use of Rhythm Control Therapy reported at time of enrollment | 638/1312 (48.6%) | 301/651 (46.2%) | 337/661 (51.0%) | 400/782 (51.2%) | 187/395 (47.3%) | 213/387 (55.0%) | 0.2640 |
| ≥ 2 Rhythm Control Drugs | 109/638 (17.1%) | 43/301 (14.3%) | 66/337 (19.6%) | 79/400 (19.8%) | 47/187 (25.1%) | 32/213 (15.0%) | 0.2778 |
| Crossover | 263/1385 (19.0%) | 62/695 (8.9%) | 201/690 (29.1%) | 140/819 (17.1%) | 40/413 (9.7%) | 100/406 (24.6%) | 0.2660 |
| Study Withdrawal | 138/1385 (10.0%) | 54/695 (7.8%) | 84/690 (12.2%) | 101/819 (12.3%) | 49/413 (11.9%) | 52/406 (12.8%) | 0.0840 |
| Follow-up time | 0.0136 | ||||||
| Median (Q1, Q3) | 49.7 (30.4, 62.5) | 49.7 (31.0, 61.9) | 49.8 (30.0, 63.2) | 47.3 (28.7, 61.4) | 47.8 (28.5, 61.4) | 44.0 (29.4, 61.6) | |
| N | 1385 | 695 | 690 | 819 | 413 | 406 | |
*
p-value for comparison between overall men and overall women
Q1 and Q3=quartiles (25th and 75th percentiles), CCS=Canadian Cardiovascular Society, AF=atrial fibrillation, NYHA=New York Heart Association, CVA=cerebral vascular accident, TIA=transient ischemic attack