Baseline characteristics by occurrence and location of ICH
| . | No ICH(n = 17 966) . | ICH . | P* . | |||
|---|---|---|---|---|---|---|
| Overall(n = 174) . | Intraparenchymal hemorrhage (n = 105) . | Subdural hematoma (n = 44) . | Subarachnoid hemorrhage (n = 14) . | |||
| Age, y | 70 (63, 76) | 74 (67, 78) | 72 (65, 76) | 76 (70, 79) | 79 (67, 82) | <.001 |
| Female sex | 6 333 (35.2) | 60 (34.5) | 38 (36.2) | 13 (29.5) | 4 (28.6) | .833 |
| Region | <.001 | |||||
| North America | 4 433 (24.7) | 30 (17.2) | 14 (13.3) | 12 (27.3) | 4 (28.6) | |
| Latin America | 3 424 (19.1) | 36 (20.7) | 25 (23.8) | 5 (11.4) | 1 (7.1) | |
| Europe | 7 265 (40.4) | 48 (27.6) | 27 (25.7) | 13 (29.5) | 5 (35.7) | |
| Asia Pacific | 2 844 (15.8) | 60 (34.5) | 39 (37.1) | 14 (31.8) | 4 (28.6) | |
| Race | <.001 | |||||
| White | 14 865 (82.7) | 116 (66.7) | 64 (61.0) | 31 (70.5) | 13 (92.9) | |
| Asian | 2 576 (14.3) | 54 (31.0) | 38 (36.2) | 12 (27.3) | 1 (7.1) | |
| Other | 525 (2.9) | 4 (2.3) | 3 (2.9) | 1 (2.3) | 0 (0.0) | |
| Systolic blood pressure at baseline, mm Hg | 130 (120, 140) | 132 (121, 140) | 131 (125, 140) | 130 (119, 138) | 130 (128, 138) | .119 |
| Diastolic blood pressure at baseline, mm Hg | 80 (70, 87) | 80 (72, 86) | 80 (75, 88) | 80 (70, 83) | 77 (70, 80) | .792 |
| Weight at baseline, kg | 82 (70, 96) | 76 (63, 87) | 76 (62, 85) | 76 (66, 91) | 80 (70, 92) | <.001 |
| Peripheral artery disease | 873 (4.9) | 9 (5.2) | 3 (2.9) | 4 (9.1) | 2 (14.3) | .878 |
| Prior clinically relevant or spontaneous bleeding | 3 006 (16.7) | 27 (15.5) | 12 (11.4) | 11 (25.0) | 3 (21.4) | .669 |
| History of fall within previous year | 740 (4.5) | 12 (7.6) | 4 (4.3) | 5 (12.2) | 3 (23.1) | .068 |
| Type of atrial fibrillation | .327 | |||||
| Paroxysmal | 2 754 (15.3) | 22 (12.6) | 15 (14.3) | 6 (13.6) | 1 (7.1) | |
| Persistent or permanent | 15 209 (84.7) | 152 (87.4) | 90 (85.7) | 38 (86.4) | 13 (92.9) | |
| Prior use of vitamin K antagonists (> 30 d) | 10 286 (57.3) | 90 (51.7) | 48 (45.7) | 29 (65.9) | 9 (64.3) | .142 |
| Qualifying risk factors | ||||||
| Age ≥75 y | 5 578 (31.0) | 77 (44.3) | 39 (37.1) | 24 (54.5) | 10 (71.4) | <.001 |
| Prior stroke or TIA or systemic embolism | 3 467 (19.3) | 56 (32.2) | 38 (36.2) | 14 (31.8) | 1 (7.1) | <.001 |
| Heart failure or reduced LVEF | 6 388 (35.6) | 47 (27.0) | 29 (27.6) | 16 (36.4) | 1 (7.1) | .019 |
| Diabetes | 4 487 (25.0) | 39 (22.4) | 27 (25.7) | 5 (11.4) | 3 (21.4) | .437 |
| Hypertension requiring treatment | 15 709 (87.4) | 150 (86.2) | 96 (91.4) | 31 (70.5) | 13 (92.9) | .626 |
| CHADS2 (mean, SD) | 2.11 (1.10) | 2.40 (1.24) | 2.50 (1.27) | 2.32 (1.36) | 2.07 (0.92) | .003 |
| CHADS2 distribution | .013 | |||||
| ≤1 | 6 121 (34.1) | 48 (27.6) | 27 (25.7) | 15 (34.1) | 4 (28.6) | |
| 2 | 6 436 (35.8) | 56 (32.2) | 34 (32.4) | 12 (27.3) | 6 (42.9) | |
| ≥3 | 5 409 (30.1) | 70 (40.2) | 44 (41.9) | 17 (38.6) | 4 (28.6) | |
| Medications at time of randomization | ||||||
| Angiotensin-converting-enzyme inhibitor or angiotensin receptor blockers | 12 668 (71.6) | 122 (71.3) | 79 (75.2) | 26 (60.5) | 10 (71.4) | .931 |
| Amiodarone | 2 022 (11.4) | 25 (14.6) | 18 (17.1) | 5 (11.6) | 0 (0.0) | .193 |
| β-blocker | 11 337 (64.1) | 109 (63.7) | 66 (62.9) | 27 (62.8) | 9 (64.3) | .919 |
| Aspirin | 5 542 (30.8) | 66 (37.9) | 39 (37.1) | 17 (38.6) | 5 (35.7) | .044 |
| Clopidogrel | 333 (1.9) | 4 (2.3) | 2 (1.9) | 2 (4.5) | 0 (0.0) | .568 |
| Digoxin | 5 766 (32.6) | 53 (31.0) | 35 (33.3) | 10 (23.3) | 4 (28.6) | .654 |
| Calcium blocker | 5 498 (31.1) | 48 (28.1) | 25 (23.8) | 12 (27.9) | 6 (42.9) | .395 |
| Statin | 7 370 (41.7) | 72 (42.1) | 45 (42.9) | 18 (41.9) | 4 (28.6) | .911 |
| Nonsteroidal anti-inflammatory agent | 1 501 (8.5) | 17 (9.9) | 8 (7.6) | 7 (16.3) | 2 (14.3) | .498 |
| Gastric antacid drugs | 3 300 (18.7) | 36 (21.1) | 18 (17.1) | 13 (30.2) | 3 (21.4) | .425 |
| Renal function (creatinine clearance) | <.001 | |||||
| Normal (80 mL/min) | 7 448 (41.6) | 48 (27.7) | 33 (31.7) | 9 (20.5) | 3 (21.4) | |
| Mild impairment (>50-80 mL/min) | 7 488 (41.8) | 77 (44.5) | 45 (43.3) | 19 (43.2) | 7 (50.0) | |
| Moderate impairment (>30-50 mL/min) | 2 693 (15.1) | 44 (25.4) | 23 (22.1) | 16 (36.4) | 3 (21.4) | |
| Severe impairment (≤30 mL/min) | 264 (1.5) | 4 (2.3) | 3 (2.9) | 0 (0.0) | 1 (7.1) | |
| Randomized to warfarin | 8 930 (49.7) | 122 (70.1) | 72 (68.6) | 33 (75.0) | 9 (64.3) | <.001 |
| . | No ICH(n = 17 966) . | ICH . | P* . | |||
|---|---|---|---|---|---|---|
| Overall(n = 174) . | Intraparenchymal hemorrhage (n = 105) . | Subdural hematoma (n = 44) . | Subarachnoid hemorrhage (n = 14) . | |||
| Age, y | 70 (63, 76) | 74 (67, 78) | 72 (65, 76) | 76 (70, 79) | 79 (67, 82) | <.001 |
| Female sex | 6 333 (35.2) | 60 (34.5) | 38 (36.2) | 13 (29.5) | 4 (28.6) | .833 |
| Region | <.001 | |||||
| North America | 4 433 (24.7) | 30 (17.2) | 14 (13.3) | 12 (27.3) | 4 (28.6) | |
| Latin America | 3 424 (19.1) | 36 (20.7) | 25 (23.8) | 5 (11.4) | 1 (7.1) | |
| Europe | 7 265 (40.4) | 48 (27.6) | 27 (25.7) | 13 (29.5) | 5 (35.7) | |
| Asia Pacific | 2 844 (15.8) | 60 (34.5) | 39 (37.1) | 14 (31.8) | 4 (28.6) | |
| Race | <.001 | |||||
| White | 14 865 (82.7) | 116 (66.7) | 64 (61.0) | 31 (70.5) | 13 (92.9) | |
| Asian | 2 576 (14.3) | 54 (31.0) | 38 (36.2) | 12 (27.3) | 1 (7.1) | |
| Other | 525 (2.9) | 4 (2.3) | 3 (2.9) | 1 (2.3) | 0 (0.0) | |
| Systolic blood pressure at baseline, mm Hg | 130 (120, 140) | 132 (121, 140) | 131 (125, 140) | 130 (119, 138) | 130 (128, 138) | .119 |
| Diastolic blood pressure at baseline, mm Hg | 80 (70, 87) | 80 (72, 86) | 80 (75, 88) | 80 (70, 83) | 77 (70, 80) | .792 |
| Weight at baseline, kg | 82 (70, 96) | 76 (63, 87) | 76 (62, 85) | 76 (66, 91) | 80 (70, 92) | <.001 |
| Peripheral artery disease | 873 (4.9) | 9 (5.2) | 3 (2.9) | 4 (9.1) | 2 (14.3) | .878 |
| Prior clinically relevant or spontaneous bleeding | 3 006 (16.7) | 27 (15.5) | 12 (11.4) | 11 (25.0) | 3 (21.4) | .669 |
| History of fall within previous year | 740 (4.5) | 12 (7.6) | 4 (4.3) | 5 (12.2) | 3 (23.1) | .068 |
| Type of atrial fibrillation | .327 | |||||
| Paroxysmal | 2 754 (15.3) | 22 (12.6) | 15 (14.3) | 6 (13.6) | 1 (7.1) | |
| Persistent or permanent | 15 209 (84.7) | 152 (87.4) | 90 (85.7) | 38 (86.4) | 13 (92.9) | |
| Prior use of vitamin K antagonists (> 30 d) | 10 286 (57.3) | 90 (51.7) | 48 (45.7) | 29 (65.9) | 9 (64.3) | .142 |
| Qualifying risk factors | ||||||
| Age ≥75 y | 5 578 (31.0) | 77 (44.3) | 39 (37.1) | 24 (54.5) | 10 (71.4) | <.001 |
| Prior stroke or TIA or systemic embolism | 3 467 (19.3) | 56 (32.2) | 38 (36.2) | 14 (31.8) | 1 (7.1) | <.001 |
| Heart failure or reduced LVEF | 6 388 (35.6) | 47 (27.0) | 29 (27.6) | 16 (36.4) | 1 (7.1) | .019 |
| Diabetes | 4 487 (25.0) | 39 (22.4) | 27 (25.7) | 5 (11.4) | 3 (21.4) | .437 |
| Hypertension requiring treatment | 15 709 (87.4) | 150 (86.2) | 96 (91.4) | 31 (70.5) | 13 (92.9) | .626 |
| CHADS2 (mean, SD) | 2.11 (1.10) | 2.40 (1.24) | 2.50 (1.27) | 2.32 (1.36) | 2.07 (0.92) | .003 |
| CHADS2 distribution | .013 | |||||
| ≤1 | 6 121 (34.1) | 48 (27.6) | 27 (25.7) | 15 (34.1) | 4 (28.6) | |
| 2 | 6 436 (35.8) | 56 (32.2) | 34 (32.4) | 12 (27.3) | 6 (42.9) | |
| ≥3 | 5 409 (30.1) | 70 (40.2) | 44 (41.9) | 17 (38.6) | 4 (28.6) | |
| Medications at time of randomization | ||||||
| Angiotensin-converting-enzyme inhibitor or angiotensin receptor blockers | 12 668 (71.6) | 122 (71.3) | 79 (75.2) | 26 (60.5) | 10 (71.4) | .931 |
| Amiodarone | 2 022 (11.4) | 25 (14.6) | 18 (17.1) | 5 (11.6) | 0 (0.0) | .193 |
| β-blocker | 11 337 (64.1) | 109 (63.7) | 66 (62.9) | 27 (62.8) | 9 (64.3) | .919 |
| Aspirin | 5 542 (30.8) | 66 (37.9) | 39 (37.1) | 17 (38.6) | 5 (35.7) | .044 |
| Clopidogrel | 333 (1.9) | 4 (2.3) | 2 (1.9) | 2 (4.5) | 0 (0.0) | .568 |
| Digoxin | 5 766 (32.6) | 53 (31.0) | 35 (33.3) | 10 (23.3) | 4 (28.6) | .654 |
| Calcium blocker | 5 498 (31.1) | 48 (28.1) | 25 (23.8) | 12 (27.9) | 6 (42.9) | .395 |
| Statin | 7 370 (41.7) | 72 (42.1) | 45 (42.9) | 18 (41.9) | 4 (28.6) | .911 |
| Nonsteroidal anti-inflammatory agent | 1 501 (8.5) | 17 (9.9) | 8 (7.6) | 7 (16.3) | 2 (14.3) | .498 |
| Gastric antacid drugs | 3 300 (18.7) | 36 (21.1) | 18 (17.1) | 13 (30.2) | 3 (21.4) | .425 |
| Renal function (creatinine clearance) | <.001 | |||||
| Normal (80 mL/min) | 7 448 (41.6) | 48 (27.7) | 33 (31.7) | 9 (20.5) | 3 (21.4) | |
| Mild impairment (>50-80 mL/min) | 7 488 (41.8) | 77 (44.5) | 45 (43.3) | 19 (43.2) | 7 (50.0) | |
| Moderate impairment (>30-50 mL/min) | 2 693 (15.1) | 44 (25.4) | 23 (22.1) | 16 (36.4) | 3 (21.4) | |
| Severe impairment (≤30 mL/min) | 264 (1.5) | 4 (2.3) | 3 (2.9) | 0 (0.0) | 1 (7.1) | |
| Randomized to warfarin | 8 930 (49.7) | 122 (70.1) | 72 (68.6) | 33 (75.0) | 9 (64.3) | <.001 |
Values presented as median (25th, 75th percentiles) or n (%).
LVEF, left ventricular ejection fraction; SD, standard deviation.
P value compares patients with ICH (overall) vs patients without ICH.