Introduction
Methods and Analysis
Study Design and Assessments
Item | Time point during study | ||
---|---|---|---|
Registration | Baselinea | Every 6 months (± 3 months) | |
Confirmation of inclusion and exclusion criteria | ○ | ||
Consent, visit status, and health check | ○ | ○ | |
Patient characteristicsb | ○ | ||
Antithrombotic drug status | ○ | ○ | |
Administration status of medications other than antithrombotic drugsc | ○ | ○ | |
Status of implementation of invasive procedures | ○ | ||
Blood-clotting test (PT-INR)d,e | ○ | ○ | |
Clinical course and laboratory teste | ○ | ○ | |
Echocardiographyf | ○ | ○f | |
Adverse eventsg | Throughout |
Patients and Eligibility Criteria
Study Endpoints
Statistical Analysis
Results
Characteristic | All (N = 899) | Warfarin-based therapy (n = 494) | DOAC-based therapy (n = 263) | Antiplatelet therapy (n = 87) | No antithrombotic drugs (n = 55) |
---|---|---|---|---|---|
Male | 411 (45.7) | 231 (46.8) | 105 (39.9) | 47 (54.0) | 28 (50.9) |
Age (years), mean ± SD | 80.3 ± 7.0 | 79.5 ± 6.7 | 82.4 ± 6.5 | 79.7 ± 8.1 | 79.4 ± 8.2 |
Weight (kg), mean ± SD | 53.8 ± 11.4 | 54.0 ± 11.3 | 53.4 ± 11.3 | 54.3 ± 12.1 | 53.7 ± 11.5 |
BMI (kg/m2), mean ± SD | 22.2 ± 3.7 | 22.1 ± 3.4 | 22.4 ± 4.2 | 22.4 ± 3.3 | 21.8 ± 3.8 |
CHADS2 score | |||||
Mean ± SD | 2.5 ± 1.2 | 2.4 ± 1.2 | 2.7 ± 1.2 | 2.4 ± 1.2 | 2.2 ± 1.1 |
≥ 2.0 | 678 (81.0) | 362 (78.5) | 219 (87.6) | 63 (80.8) | 34 (70.8) |
CHA2DS2-VASc score | |||||
Mean ± SD | 4.1 ± 1.5 | 4.0 ± 1.4 | 4.5 ± 1.5 | 3.8 ± 1.5 | 3.6 ± 1.5 |
≥ 3.0 | 738 (87.8) | 397 (85.9) | 241 (95.3) | 61 (78.2) | 39 (81.3) |
HAS-BLED score | |||||
Mean ± SD | 2.5 ± 1.1 | 2.5 ± 1.1 | 2.4 ± 1.0 | 2.9 ± 1.2 | 2.1 ± 1.1 |
≥ 3.0 | 376 (45.1) | 213 (46.5) | 101 (40.1) | 47 (60.3) | 15 (31.3) |
eGFR (mL/min/1.73 m2) | 46.6 ± 17.7 | 45.5 ± 18.5 | 48.1 ± 14.8 | 47.8 ± 20.6 | 48.3 ± 18.1 |
Ccr (mL/min) | |||||
Mean ± SD | 40.4 ± 18.3 | 40.2 ± 18.7 | 40.9 ± 16.4 | 39.1 ± 21.1 | 42.3 ± 20.5 |
Type of AF | |||||
Paroxysmal | 332 (36.9) | 121 (24.5) | 125 (47.5) | 56 (64.4) | 30 (54.6) |
Persistent | 311 (34.6) | 196 (39.7) | 76 (28.9) | 24 (27.6) | 15 (27.3) |
Permanent | 256 (28.5) | 177 (35.8) | 62 (23.6) | 7 (8.1) | 10 (18.2) |
Previous history of CVD | |||||
Ischemic stroke | 125 (13.9) | 58 (11.7) | 49 (18.6) | 15 (17.2) | 3 (5.5) |
Hemorrhagic stroke | 21 (2.3) | 11 (2.2) | 6 (2.3) | 3 (3.5) | 1 (1.8) |
Intracranial hemorrhage | 30 (3.3) | 13 (2.6) | 11 (4.2) | 4 (4.6) | 2 (3.6) |
Systemic embolism | 11 (1.2) | 7 (1.4) | 3 (1.1) | 1 (1.2) | 0 (0.0) |
Major bleeding | 47 (5.2) | 28 (5.7) | 9 (3.4) | 6 (6.9) | 4 (7.3) |
Comorbidities | |||||
Hypertension | 685 (76.2) | 356 (72.1) | 215 (81.8) | 74 (85.1) | 40 (72.7) |
Heart failure | 493 (54.8) | 275 (55.7) | 145 (55.1) | 46 (52.9) | 27 (49.1) |
Dyslipidemia | 444 (49.4) | 240 (48.6) | 135 (51.3) | 47 (54.0) | 22 (40.0) |
Diabetes mellitus | 190 (21.1) | 110 (22.3) | 56 (21.3) | 18 (20.7) | 6 (10.9) |
Renal dysfunction | 86 (9.6) | 52 (10.5) | 15 (5.7) | 13 (14.9) | 6 (10.9) |
Chronic respiratory disease | 86 (9.6) | 45 (9.1) | 31 (11.8) | 6 (6.9) | 4 (7.3) |
Malignant tumor | 68 (7.6) | 31 (6.3) | 27 (10.3) | 6 (6.9) | 4 (7.3) |
Myocardial infarction | 45 (5.0) | 23 (4.7) | 7 (2.7) | 13 (14.9) | 2 (3.6) |
Peripheral arterial disease | 33 (3.7) | 15 (3.0) | 11 (4.2) | 2 (2.3) | 5 (9.1) |
Thrombosis and embolism | 28 (3.1) | 13 (2.6) | 13 (4.9) | 2 (2.3) | 0 (0.0) |
Left ventricular ejection fraction | |||||
< 40% | 56 (6.7) | 43 (9.4) | 6 (2.4) | 5 (6.2) | 2 (3.9) |
40% to 49% | 73 (8.7) | 50 (10.9) | 14 (5.7) | 5 (6.2) | 4 (7.8) |
≥ 50% | 709 (84.6) | 367 (79.8) | 226 (91.9) | 71 (87.7) | 45 (88.2) |
Treatment
Characteristic | All (N = 899) | Warfarin-based therapy (n = 494) | DOAC-based therapy (n = 263) | Antiplatelet therapy (n = 87) | No antithrombotic drugs (n = 55) |
---|---|---|---|---|---|
Prosthesis position | |||||
Aortic valve | 589 (65.5) | 259 (52.4) | 221 (84.0) | 70 (80.5) | 39 (70.9) |
Mitral valve | 198 (22.0) | 147 (29.8) | 31 (11.8) | 9 (10.3) | 11 (20.0) |
Both valves | 112 (12.5) | 88 (17.8) | 11 (4.2) | 8 (9.2) | 5 (9.1) |
Aortic valve | n = 589 | n = 259 | n = 211 | n = 70 | n = 39 |
VHD subtype | |||||
Stenosis | 445 (75.6) | 183 (70.7) | 186 (84.2) | 50 (71.4) | 26 (66.7) |
Regurgitation | 114 (19.4) | 62 (23.9) | 28 (12.7) | 15 (21.4) | 9 (23.1) |
Others | 30 (5.1) | 14 (5.4) | 7 (3.3) | 5 (7.1) | 4 (10.3) |
Operation type | |||||
Surgery | 352 (59.8) | 193 (74.5) | 79 (35.8) | 49 (70.0) | 31 (79.5) |
TAVI | 237 (40.2) | 66 (25.5) | 142 (64.3) | 21 (30.0) | 8 (20.5) |
History of replacement | |||||
First replacement | 562 (95.4) | 242 (93.4) | 215 (97.3) | 68 (97.1) | 37 (94.9) |
Re-replacement | 25 (4.2) | 16 (6.2) | 5 (2.3) | 2 (2.9) | 2 (5.1) |
Unknown | 2 (0.3) | 1 (0.4) | 1 (0.5) | 0 (0.0) | 0 (0.0) |
Mitral valve | n = 198 | n = 147 | n = 31 | n = 9 | n = 11 |
VHD subtype | |||||
Stenosis | 84 (42.2) | 66 (44.9) | 12 (38.7) | 2 (22.2) | 4 (36.4) |
Regurgitation | 95 (48.0) | 67 (45.6) | 18 (58.1) | 4 (44.4) | 6 (54.6) |
Others | 19 (9.7) | 14 (9.6) | 1 (3.2) | 3 (33.3) | 1 (9.1) |
Operation type | |||||
Surgery | 198 (100.0) | 147 (100.0) | 31 (100.0) | 9 (100.0) | 11 (100.0) |
History of replacement | |||||
First replacement | 174 (87.9) | 127 (86.4) | 29 (93.6) | 8 (88.9) | 10 (90.9) |
Re-replacement | 24 (12.1) | 20 (13.6) | 2 (6.5) | 1 (11.1) | 1 (9.1) |
Treatment agent | All (N = 899) |
---|---|
No antithrombotic drug | 55 (6.1) |
Warfarin-based therapy | 494 (55.0) |
No antiplatelet drug | 355 |
With antiplatelet drug | 139 |
With aspirin (monotherapy) | 121 |
With P2Y12 (monotherapy) | 12 |
With DAPT | 0 |
With others | 6 |
DOAC-based therapy | 263 (29.3) |
No antiplatelet drug | 189 |
With antiplatelet drug | 74 |
With aspirin (monotherapy) | 54 |
With P2Y12 (monotherapy) | 17 |
With DAPT | 0 |
With others | 3 |
Antiplatelet therapy (without warfarin/DOAC) | 87 (9.7) |
Aspirin (monotherapy) | 68 |
P2Y12 (monotherapy) | 11 |
DAPT | 4 |
With others | 4 |
Warfarin | n = 494 |
PT-INR | |
Age < 70 years | n = 27 |
< 2.0 | 13 (52.0) |
2.0–3.0 | 12 (48.0) |
> 3.0 | 0 (0.0) |
Age ≥ 70 years | n = 467 |
< 1.6 | 91 (21.6) |
1.6–2.6 | 293 (69.4) |
> 2.6 | 38 (9.0) |