Table 1.
Subject characteristics and medical history
| US subjects (n = 56) | European subjects (n = 57) | Japanese subjects (n = 30) | All subjects (n = 143) | P value† | |
|---|---|---|---|---|---|
| Age, y, mean ± SD (n) | 63.4 ± 9.8 (56) | 60.7 ± 10.9 (57) | 62.6 ± 13.0 (30) | 62.2 ± 10.9 (143) | .4245 |
| Sex, % (n/N) | |||||
| Female | 48.2% (27/56) | 28.1% (16/57) | 16.7% (5/30) | 33.6% (48/143) | .0067 |
| Male | 51.8% (29/56) | 71.9% (41/57) | 83.3% (25/30) | 66.4% (95/143) | .0067 |
| BMI, mean ± SD (n) | 32.3 ± 6.7 (56) | 27.0 ± 3.6 (57) | 23.9 ± 3.1 (30) | 28.4 ± 6.0 (143) | <.0001 |
| History of other arrhythmia, % (n/N) | 42.9% (24/56) | 19.3% (11/57) | 16.7% (5/30) | 28.0% (40/143) | .0061 |
| Atrial flutter | 28.6% (16/56) | 15.8% (9/57) | 13.3% (4/30) | 20.3% (29/143) | .1362 |
| Atrial tachycardia | 5.4% (3/56) | 0.0% (0/57) | 0.0% (0/30) | 2.1% (3/143) | .0925 |
| Ventricular tachycardia | 10.7% (6/56) | 1.8% (1/57) | 0.0% (0/30) | 4.9% (7/143) | .0330 |
| Heart block or atrioventricular dysfunction | 12.5% (7/56) | 3.5% (2/57) | 3.3% (1/30) | 7.0% (10/143) | .1169 |
| History of hypertension, % (n/N) | 75.0% (42/56) | 43.9% (25/57) | 53.3% (16/30) | 58.0% (83/143) | .0030 |
| History of any procedure to occlude or close the left atrial appendage, % (n/N) | 0.0% (0/56) | 0.0% (0/57) | 0.0% (0/30) | 0.0% (0/143) | n/a |
| History of class I/III AAD, % (n/N) | 89.3% (50/56) | 84.2% (48/57) | 73.3% (22/30) | 83.9% (120/143) | .1581 |
| Pacemaker or implantable cardiac monitor, % (n/N) | 1.8% (1/56) | 1.8% (1/57) | 0.0% (0/30) | 1.4% (2/143) | .7639 |
| Left atrial diameter (cm) | 4.0 ± 0.6 (54) | 3.9 ± 0.8 (36) | 3.6 ± 0.6 (24) | 3.9 ± 0.7 (114) | .0317 |
AAD = antiarrhythmic drugs; BMI = body mass index; n/a = not applicable.
†
P-value from 1-way analysis of variance for continuous variables and χ2 test for categorical variables.