| . | Apixaban (n = 749) . | Standard of care (n = 751) . |
|---|---|---|
| Age, years | 81.6 (6.1) | 82.3 (6.4) |
| Sex | ||
| Female | 405 (54.1%) | 391 (52.1%) |
| Male | 344 (45.9%) | 360 (47.9%) |
| Body mass index, kg/m2 | 27.52 (5.45) | 27.33 (5.16) |
| Diabetes mellitus | 221 (29.5%) | 214 (28.5%) |
| Hypertension | 606 (80.9%) | 601 (80.0%) |
| EuroSCORE IIb | 4.84 (4.11) | 5.10 (4.34) |
| STS risk scorec | 5.14 (5.02) | 5.14 (5.38) |
| Glomerular filtration rate, mL/min | 62.87 (30.75) | 61.58 (31.00) |
| NYHA Class III or IV | 342 (46.8%) | 343 (47.6%) |
| Congestive heart failure | 292 (39.0%) | 284 (37.8%) |
| Prior myocardial infarction | 83 (11.1%) | 90 (12.0%) |
| Prior PCI | 202 (27.0%) | 188 (25.0%) |
| PCI <1 month | 38 (5.1%) | 36 (4.8%) |
| Prior coronary artery bypass grafting | 65 (9.1%) | 56 (7.8%) |
| Peripheral artery disease | 90 (12.0%) | 111 (14.8%) |
| Prior stroke | 78 (10.4%) | 89 (11.9%) |
| Prior venous thromboembolic disease | 61 (8.1%) | 38 (5.1%) |
| Chronic obstructive pulmonary disease | 119 (15.9%) | 111 (14.8%) |
| Atrial fibrillation | 212 (28.3%) | 199 (26.5%) |
| CHA2DS2-VASc score | 4.4 (1.4) | 4.3 (1.4) |
| Pre-TAVI antithrombotic treatment | ||
| VKA | 123 (16.4%) | 111 (14.8%) |
| Non-VKA oral anticoagulant | 66 (8.8%) | 55 (7.3%) |
| Single antiplatelet therapy | 428 (57.1%) | 443 (59.0%) |
| Dual antiplatelet therapy | 104 (13.9%) | 94 (12.5%) |
| Antithrombotic treatment at randomization | ||
| VKA only | 155 (20.6%) | |
| Apixaban only | 552 (73.7%) | |
| Apixaban 2.5 mg b.i.d. | 258 (34.4%) | — |
| Apixaban 5 mg b.i.d. | 491 (65.6%) | — |
| Aspirin or clopidogrel | — | 112 (14.9%) |
| Aspirin and clopidogrel | — | 427 (56.9%) |
| Dual therapyd | 173 (23.1%) | 54 (7.2%) |
| Triple therapye | 24 (3.2%) | 3 (0.4%) |
| Procedural characteristics | ||
| Type of device | ||
| Self-expanding | 395 (52.8%) | 386 (51.5%) |
| Balloon-expanding | 353 (47.2%) | 363 (48.5%) |
| Valve-in-valve | 40 (5.3%) | 35 (4.7%) |
| Post-TAVI echocardiographic characteristics | ||
| Aortic valvular area, cm2 | 1.74 (0.59) | 1.80 (0.50) |
| Mean aortic valve gradient, mmHg | 11.2 (6.4) | 10.7 (4.9) |
| Left ventricular ejection fraction, % | 59.0 (10.4) | 59.0 (10.8) |
| Paravalvular aortic regurgitation | ||
| Mild | 35 (15.4%) | 40 (16.6%) |
| Moderate to severe | 3 (1.3%) | 1 (0.4%) |
| . | Apixaban (n = 749) . | Standard of care (n = 751) . |
|---|---|---|
| Age, years | 81.6 (6.1) | 82.3 (6.4) |
| Sex | ||
| Female | 405 (54.1%) | 391 (52.1%) |
| Male | 344 (45.9%) | 360 (47.9%) |
| Body mass index, kg/m2 | 27.52 (5.45) | 27.33 (5.16) |
| Diabetes mellitus | 221 (29.5%) | 214 (28.5%) |
| Hypertension | 606 (80.9%) | 601 (80.0%) |
| EuroSCORE IIb | 4.84 (4.11) | 5.10 (4.34) |
| STS risk scorec | 5.14 (5.02) | 5.14 (5.38) |
| Glomerular filtration rate, mL/min | 62.87 (30.75) | 61.58 (31.00) |
| NYHA Class III or IV | 342 (46.8%) | 343 (47.6%) |
| Congestive heart failure | 292 (39.0%) | 284 (37.8%) |
| Prior myocardial infarction | 83 (11.1%) | 90 (12.0%) |
| Prior PCI | 202 (27.0%) | 188 (25.0%) |
| PCI <1 month | 38 (5.1%) | 36 (4.8%) |
| Prior coronary artery bypass grafting | 65 (9.1%) | 56 (7.8%) |
| Peripheral artery disease | 90 (12.0%) | 111 (14.8%) |
| Prior stroke | 78 (10.4%) | 89 (11.9%) |
| Prior venous thromboembolic disease | 61 (8.1%) | 38 (5.1%) |
| Chronic obstructive pulmonary disease | 119 (15.9%) | 111 (14.8%) |
| Atrial fibrillation | 212 (28.3%) | 199 (26.5%) |
| CHA2DS2-VASc score | 4.4 (1.4) | 4.3 (1.4) |
| Pre-TAVI antithrombotic treatment | ||
| VKA | 123 (16.4%) | 111 (14.8%) |
| Non-VKA oral anticoagulant | 66 (8.8%) | 55 (7.3%) |
| Single antiplatelet therapy | 428 (57.1%) | 443 (59.0%) |
| Dual antiplatelet therapy | 104 (13.9%) | 94 (12.5%) |
| Antithrombotic treatment at randomization | ||
| VKA only | 155 (20.6%) | |
| Apixaban only | 552 (73.7%) | |
| Apixaban 2.5 mg b.i.d. | 258 (34.4%) | — |
| Apixaban 5 mg b.i.d. | 491 (65.6%) | — |
| Aspirin or clopidogrel | — | 112 (14.9%) |
| Aspirin and clopidogrel | — | 427 (56.9%) |
| Dual therapyd | 173 (23.1%) | 54 (7.2%) |
| Triple therapye | 24 (3.2%) | 3 (0.4%) |
| Procedural characteristics | ||
| Type of device | ||
| Self-expanding | 395 (52.8%) | 386 (51.5%) |
| Balloon-expanding | 353 (47.2%) | 363 (48.5%) |
| Valve-in-valve | 40 (5.3%) | 35 (4.7%) |
| Post-TAVI echocardiographic characteristics | ||
| Aortic valvular area, cm2 | 1.74 (0.59) | 1.80 (0.50) |
| Mean aortic valve gradient, mmHg | 11.2 (6.4) | 10.7 (4.9) |
| Left ventricular ejection fraction, % | 59.0 (10.4) | 59.0 (10.8) |
| Paravalvular aortic regurgitation | ||
| Mild | 35 (15.4%) | 40 (16.6%) |
| Moderate to severe | 3 (1.3%) | 1 (0.4%) |
Data are mean (SD), unless otherwise indicated. CHA2DS2-VASc = congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischaemic attack, vascular disease, age 65–74 years, sex category. NYHA, New York Heart Association; PCI, percutaneous coronary intervention; SD, standard deviation; TAVI, transcatheter aortic-valve replacement; VKA, vitamin K antagonist.
Percentages may not total 100 because of rounding.
Scores on the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II), which measure patient risk at the time of cardiovascular surgery, are calculated by means of logistic-regression equations. A score of >10% indicates high risk, 5–10% intermediate risk, and <5% low risk.
Society of Thoracic Surgeons (STS) risk scores, which measure patient risk at the time of cardiovascular surgery, are calculated by means of logistic-regression equations. A score of >8% indicates high risk, 3–8% intermediate risk, and <3% low risk.
Combination of VKA or apixaban with aspirin or clopidogrel.
Combination of VKA or apixaban with aspirin and clopidogrel.
| . | Apixaban (n = 749) . | Standard of care (n = 751) . |
|---|---|---|
| Age, years | 81.6 (6.1) | 82.3 (6.4) |
| Sex | ||
| Female | 405 (54.1%) | 391 (52.1%) |
| Male | 344 (45.9%) | 360 (47.9%) |
| Body mass index, kg/m2 | 27.52 (5.45) | 27.33 (5.16) |
| Diabetes mellitus | 221 (29.5%) | 214 (28.5%) |
| Hypertension | 606 (80.9%) | 601 (80.0%) |
| EuroSCORE IIb | 4.84 (4.11) | 5.10 (4.34) |
| STS risk scorec | 5.14 (5.02) | 5.14 (5.38) |
| Glomerular filtration rate, mL/min | 62.87 (30.75) | 61.58 (31.00) |
| NYHA Class III or IV | 342 (46.8%) | 343 (47.6%) |
| Congestive heart failure | 292 (39.0%) | 284 (37.8%) |
| Prior myocardial infarction | 83 (11.1%) | 90 (12.0%) |
| Prior PCI | 202 (27.0%) | 188 (25.0%) |
| PCI <1 month | 38 (5.1%) | 36 (4.8%) |
| Prior coronary artery bypass grafting | 65 (9.1%) | 56 (7.8%) |
| Peripheral artery disease | 90 (12.0%) | 111 (14.8%) |
| Prior stroke | 78 (10.4%) | 89 (11.9%) |
| Prior venous thromboembolic disease | 61 (8.1%) | 38 (5.1%) |
| Chronic obstructive pulmonary disease | 119 (15.9%) | 111 (14.8%) |
| Atrial fibrillation | 212 (28.3%) | 199 (26.5%) |
| CHA2DS2-VASc score | 4.4 (1.4) | 4.3 (1.4) |
| Pre-TAVI antithrombotic treatment | ||
| VKA | 123 (16.4%) | 111 (14.8%) |
| Non-VKA oral anticoagulant | 66 (8.8%) | 55 (7.3%) |
| Single antiplatelet therapy | 428 (57.1%) | 443 (59.0%) |
| Dual antiplatelet therapy | 104 (13.9%) | 94 (12.5%) |
| Antithrombotic treatment at randomization | ||
| VKA only | 155 (20.6%) | |
| Apixaban only | 552 (73.7%) | |
| Apixaban 2.5 mg b.i.d. | 258 (34.4%) | — |
| Apixaban 5 mg b.i.d. | 491 (65.6%) | — |
| Aspirin or clopidogrel | — | 112 (14.9%) |
| Aspirin and clopidogrel | — | 427 (56.9%) |
| Dual therapyd | 173 (23.1%) | 54 (7.2%) |
| Triple therapye | 24 (3.2%) | 3 (0.4%) |
| Procedural characteristics | ||
| Type of device | ||
| Self-expanding | 395 (52.8%) | 386 (51.5%) |
| Balloon-expanding | 353 (47.2%) | 363 (48.5%) |
| Valve-in-valve | 40 (5.3%) | 35 (4.7%) |
| Post-TAVI echocardiographic characteristics | ||
| Aortic valvular area, cm2 | 1.74 (0.59) | 1.80 (0.50) |
| Mean aortic valve gradient, mmHg | 11.2 (6.4) | 10.7 (4.9) |
| Left ventricular ejection fraction, % | 59.0 (10.4) | 59.0 (10.8) |
| Paravalvular aortic regurgitation | ||
| Mild | 35 (15.4%) | 40 (16.6%) |
| Moderate to severe | 3 (1.3%) | 1 (0.4%) |
| . | Apixaban (n = 749) . | Standard of care (n = 751) . |
|---|---|---|
| Age, years | 81.6 (6.1) | 82.3 (6.4) |
| Sex | ||
| Female | 405 (54.1%) | 391 (52.1%) |
| Male | 344 (45.9%) | 360 (47.9%) |
| Body mass index, kg/m2 | 27.52 (5.45) | 27.33 (5.16) |
| Diabetes mellitus | 221 (29.5%) | 214 (28.5%) |
| Hypertension | 606 (80.9%) | 601 (80.0%) |
| EuroSCORE IIb | 4.84 (4.11) | 5.10 (4.34) |
| STS risk scorec | 5.14 (5.02) | 5.14 (5.38) |
| Glomerular filtration rate, mL/min | 62.87 (30.75) | 61.58 (31.00) |
| NYHA Class III or IV | 342 (46.8%) | 343 (47.6%) |
| Congestive heart failure | 292 (39.0%) | 284 (37.8%) |
| Prior myocardial infarction | 83 (11.1%) | 90 (12.0%) |
| Prior PCI | 202 (27.0%) | 188 (25.0%) |
| PCI <1 month | 38 (5.1%) | 36 (4.8%) |
| Prior coronary artery bypass grafting | 65 (9.1%) | 56 (7.8%) |
| Peripheral artery disease | 90 (12.0%) | 111 (14.8%) |
| Prior stroke | 78 (10.4%) | 89 (11.9%) |
| Prior venous thromboembolic disease | 61 (8.1%) | 38 (5.1%) |
| Chronic obstructive pulmonary disease | 119 (15.9%) | 111 (14.8%) |
| Atrial fibrillation | 212 (28.3%) | 199 (26.5%) |
| CHA2DS2-VASc score | 4.4 (1.4) | 4.3 (1.4) |
| Pre-TAVI antithrombotic treatment | ||
| VKA | 123 (16.4%) | 111 (14.8%) |
| Non-VKA oral anticoagulant | 66 (8.8%) | 55 (7.3%) |
| Single antiplatelet therapy | 428 (57.1%) | 443 (59.0%) |
| Dual antiplatelet therapy | 104 (13.9%) | 94 (12.5%) |
| Antithrombotic treatment at randomization | ||
| VKA only | 155 (20.6%) | |
| Apixaban only | 552 (73.7%) | |
| Apixaban 2.5 mg b.i.d. | 258 (34.4%) | — |
| Apixaban 5 mg b.i.d. | 491 (65.6%) | — |
| Aspirin or clopidogrel | — | 112 (14.9%) |
| Aspirin and clopidogrel | — | 427 (56.9%) |
| Dual therapyd | 173 (23.1%) | 54 (7.2%) |
| Triple therapye | 24 (3.2%) | 3 (0.4%) |
| Procedural characteristics | ||
| Type of device | ||
| Self-expanding | 395 (52.8%) | 386 (51.5%) |
| Balloon-expanding | 353 (47.2%) | 363 (48.5%) |
| Valve-in-valve | 40 (5.3%) | 35 (4.7%) |
| Post-TAVI echocardiographic characteristics | ||
| Aortic valvular area, cm2 | 1.74 (0.59) | 1.80 (0.50) |
| Mean aortic valve gradient, mmHg | 11.2 (6.4) | 10.7 (4.9) |
| Left ventricular ejection fraction, % | 59.0 (10.4) | 59.0 (10.8) |
| Paravalvular aortic regurgitation | ||
| Mild | 35 (15.4%) | 40 (16.6%) |
| Moderate to severe | 3 (1.3%) | 1 (0.4%) |
Data are mean (SD), unless otherwise indicated. CHA2DS2-VASc = congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischaemic attack, vascular disease, age 65–74 years, sex category. NYHA, New York Heart Association; PCI, percutaneous coronary intervention; SD, standard deviation; TAVI, transcatheter aortic-valve replacement; VKA, vitamin K antagonist.
Percentages may not total 100 because of rounding.
Scores on the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II), which measure patient risk at the time of cardiovascular surgery, are calculated by means of logistic-regression equations. A score of >10% indicates high risk, 5–10% intermediate risk, and <5% low risk.
Society of Thoracic Surgeons (STS) risk scores, which measure patient risk at the time of cardiovascular surgery, are calculated by means of logistic-regression equations. A score of >8% indicates high risk, 3–8% intermediate risk, and <3% low risk.
Combination of VKA or apixaban with aspirin or clopidogrel.
Combination of VKA or apixaban with aspirin and clopidogrel.
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