| . | Apixaban (n = 749) . | Standard of care (n = 751) . | P-value . | Hazard ratio or odds ratioa (95% CI) . |
|---|---|---|---|---|
| Primary outcomea | 138 (18.4%) | 151 (20.1%) | 0.92 (0.73–1.16) | |
| No indication for oral anticoagulation (n = 1049) | 89 (16.9%) | 101 (19.3%) | Pint = 0.57 | 0.88 (0.66–1.17) |
| Indication for oral anticoagulation (n = 451) | 49 (22.0%) | 50 (21.9%) | 1.02 (0.69–1.51) | |
| Apixaban (n = 749) | Standard of care (n = 751) | Hazard ratio (95% CI) | ||
| Secondary efficacy outcomesb | ||||
| Death, MI, any stroke/TIA | 79 (10.5%) | 62 (8.3%) | 1.33 (0.95–1.86) | |
| Death, any stroke/TIA or systemic embolism | 78 (10.4%) | 60 (8.0%) | 1.36 (0.97–1.90) | |
| Death | 54 (7.2%) | 41 (5.5%) | 1.39 (0.93–2.09) | |
| From cardiovascular causes | 38 (5.1%) | 28 (3.7%) | 1.42 (0.87–2.32) | |
| From non-cardiovascular causes | 16 (2.1%) | 13 (1.7%) | 1.33 (0.64–2.77) | |
| Myocardial infarction | 6 (0.8%) | 5 (0.7%) | 1.22 (0.37–4.00) | |
| Stroke or TIA | 28 (3.7%) | 21 (2.8%) | 1.39 (0.79–2.44) | |
| Systemic embolism | 2 (0.3%) | 3 (0.4%) | 0.66 (0.11–3.95) | |
| Obstructive valve thrombosisc | 8 (1.1%) | 35 (4.7%) | 0.23 (0.11–0.50)a | |
| Intracardiac thrombus | 3 (0.4%) | 3 (0.4%) | 1.07 (0.22–5.30) | |
| Deep vein thrombosis or pulmonary embolism | 1 (0.1%) | 11 (1.5%) | 0.09 (0.01–0.72) | |
| Safety endpoints | ||||
| Primary safety endpointa | 64 (8.5%) | 64 (8.5%) | 1.02 (0.72–1.44) | |
| Life-threatening bleeding | 19 (2.5%) | 18 (2.4%) | 1.06 (0.56–2.02) | |
| Major bleeding | 50 (6.7%) | 48 (6.4%) | 1.07 (0.72–1.59) | |
| Minor bleeding (BARC 2 or 3a) | 70 (9.3%) | 78 (10.4%) | 0.91 (0.66–1.26) | |
| Any bleeding | 174 (23.2%) | 170 (22.6%) | 1.05 (0.85–1.30) | |
| . | Apixaban (n = 749) . | Standard of care (n = 751) . | P-value . | Hazard ratio or odds ratioa (95% CI) . |
|---|---|---|---|---|
| Primary outcomea | 138 (18.4%) | 151 (20.1%) | 0.92 (0.73–1.16) | |
| No indication for oral anticoagulation (n = 1049) | 89 (16.9%) | 101 (19.3%) | Pint = 0.57 | 0.88 (0.66–1.17) |
| Indication for oral anticoagulation (n = 451) | 49 (22.0%) | 50 (21.9%) | 1.02 (0.69–1.51) | |
| Apixaban (n = 749) | Standard of care (n = 751) | Hazard ratio (95% CI) | ||
| Secondary efficacy outcomesb | ||||
| Death, MI, any stroke/TIA | 79 (10.5%) | 62 (8.3%) | 1.33 (0.95–1.86) | |
| Death, any stroke/TIA or systemic embolism | 78 (10.4%) | 60 (8.0%) | 1.36 (0.97–1.90) | |
| Death | 54 (7.2%) | 41 (5.5%) | 1.39 (0.93–2.09) | |
| From cardiovascular causes | 38 (5.1%) | 28 (3.7%) | 1.42 (0.87–2.32) | |
| From non-cardiovascular causes | 16 (2.1%) | 13 (1.7%) | 1.33 (0.64–2.77) | |
| Myocardial infarction | 6 (0.8%) | 5 (0.7%) | 1.22 (0.37–4.00) | |
| Stroke or TIA | 28 (3.7%) | 21 (2.8%) | 1.39 (0.79–2.44) | |
| Systemic embolism | 2 (0.3%) | 3 (0.4%) | 0.66 (0.11–3.95) | |
| Obstructive valve thrombosisc | 8 (1.1%) | 35 (4.7%) | 0.23 (0.11–0.50)a | |
| Intracardiac thrombus | 3 (0.4%) | 3 (0.4%) | 1.07 (0.22–5.30) | |
| Deep vein thrombosis or pulmonary embolism | 1 (0.1%) | 11 (1.5%) | 0.09 (0.01–0.72) | |
| Safety endpoints | ||||
| Primary safety endpointa | 64 (8.5%) | 64 (8.5%) | 1.02 (0.72–1.44) | |
| Life-threatening bleeding | 19 (2.5%) | 18 (2.4%) | 1.06 (0.56–2.02) | |
| Major bleeding | 50 (6.7%) | 48 (6.4%) | 1.07 (0.72–1.59) | |
| Minor bleeding (BARC 2 or 3a) | 70 (9.3%) | 78 (10.4%) | 0.91 (0.66–1.26) | |
| Any bleeding | 174 (23.2%) | 170 (22.6%) | 1.05 (0.85–1.30) | |
BARC, Bleeding Academic Research Consortium; MI, myocardial infarction; TIA, transient ischaemic attack.
Life-threatening (including fatal) or disabling or major bleeding (BARC 4, 3a, 3b, and 3c), as defined by the Valve Academic Research Consortium-2 (VARC-2).
Death, myocardial infarction, stroke or TIA or systemic embolism, intracardiac or bioprosthesis thrombosis, episode of deep vein thrombosis or pulmonary embolism, life-threatening or disabling bleeding or major bleeding (primary endpoint).
Obstructive valve thrombosis was defined as the mean transprosthetic gradient ≥10 mmHg change from baseline (vs. hospital discharge) or > 20 mmHg or reduced leaflet mobility Grade 3 or 4 on at least one leaflet.
| . | Apixaban (n = 749) . | Standard of care (n = 751) . | P-value . | Hazard ratio or odds ratioa (95% CI) . |
|---|---|---|---|---|
| Primary outcomea | 138 (18.4%) | 151 (20.1%) | 0.92 (0.73–1.16) | |
| No indication for oral anticoagulation (n = 1049) | 89 (16.9%) | 101 (19.3%) | Pint = 0.57 | 0.88 (0.66–1.17) |
| Indication for oral anticoagulation (n = 451) | 49 (22.0%) | 50 (21.9%) | 1.02 (0.69–1.51) | |
| Apixaban (n = 749) | Standard of care (n = 751) | Hazard ratio (95% CI) | ||
| Secondary efficacy outcomesb | ||||
| Death, MI, any stroke/TIA | 79 (10.5%) | 62 (8.3%) | 1.33 (0.95–1.86) | |
| Death, any stroke/TIA or systemic embolism | 78 (10.4%) | 60 (8.0%) | 1.36 (0.97–1.90) | |
| Death | 54 (7.2%) | 41 (5.5%) | 1.39 (0.93–2.09) | |
| From cardiovascular causes | 38 (5.1%) | 28 (3.7%) | 1.42 (0.87–2.32) | |
| From non-cardiovascular causes | 16 (2.1%) | 13 (1.7%) | 1.33 (0.64–2.77) | |
| Myocardial infarction | 6 (0.8%) | 5 (0.7%) | 1.22 (0.37–4.00) | |
| Stroke or TIA | 28 (3.7%) | 21 (2.8%) | 1.39 (0.79–2.44) | |
| Systemic embolism | 2 (0.3%) | 3 (0.4%) | 0.66 (0.11–3.95) | |
| Obstructive valve thrombosisc | 8 (1.1%) | 35 (4.7%) | 0.23 (0.11–0.50)a | |
| Intracardiac thrombus | 3 (0.4%) | 3 (0.4%) | 1.07 (0.22–5.30) | |
| Deep vein thrombosis or pulmonary embolism | 1 (0.1%) | 11 (1.5%) | 0.09 (0.01–0.72) | |
| Safety endpoints | ||||
| Primary safety endpointa | 64 (8.5%) | 64 (8.5%) | 1.02 (0.72–1.44) | |
| Life-threatening bleeding | 19 (2.5%) | 18 (2.4%) | 1.06 (0.56–2.02) | |
| Major bleeding | 50 (6.7%) | 48 (6.4%) | 1.07 (0.72–1.59) | |
| Minor bleeding (BARC 2 or 3a) | 70 (9.3%) | 78 (10.4%) | 0.91 (0.66–1.26) | |
| Any bleeding | 174 (23.2%) | 170 (22.6%) | 1.05 (0.85–1.30) | |
| . | Apixaban (n = 749) . | Standard of care (n = 751) . | P-value . | Hazard ratio or odds ratioa (95% CI) . |
|---|---|---|---|---|
| Primary outcomea | 138 (18.4%) | 151 (20.1%) | 0.92 (0.73–1.16) | |
| No indication for oral anticoagulation (n = 1049) | 89 (16.9%) | 101 (19.3%) | Pint = 0.57 | 0.88 (0.66–1.17) |
| Indication for oral anticoagulation (n = 451) | 49 (22.0%) | 50 (21.9%) | 1.02 (0.69–1.51) | |
| Apixaban (n = 749) | Standard of care (n = 751) | Hazard ratio (95% CI) | ||
| Secondary efficacy outcomesb | ||||
| Death, MI, any stroke/TIA | 79 (10.5%) | 62 (8.3%) | 1.33 (0.95–1.86) | |
| Death, any stroke/TIA or systemic embolism | 78 (10.4%) | 60 (8.0%) | 1.36 (0.97–1.90) | |
| Death | 54 (7.2%) | 41 (5.5%) | 1.39 (0.93–2.09) | |
| From cardiovascular causes | 38 (5.1%) | 28 (3.7%) | 1.42 (0.87–2.32) | |
| From non-cardiovascular causes | 16 (2.1%) | 13 (1.7%) | 1.33 (0.64–2.77) | |
| Myocardial infarction | 6 (0.8%) | 5 (0.7%) | 1.22 (0.37–4.00) | |
| Stroke or TIA | 28 (3.7%) | 21 (2.8%) | 1.39 (0.79–2.44) | |
| Systemic embolism | 2 (0.3%) | 3 (0.4%) | 0.66 (0.11–3.95) | |
| Obstructive valve thrombosisc | 8 (1.1%) | 35 (4.7%) | 0.23 (0.11–0.50)a | |
| Intracardiac thrombus | 3 (0.4%) | 3 (0.4%) | 1.07 (0.22–5.30) | |
| Deep vein thrombosis or pulmonary embolism | 1 (0.1%) | 11 (1.5%) | 0.09 (0.01–0.72) | |
| Safety endpoints | ||||
| Primary safety endpointa | 64 (8.5%) | 64 (8.5%) | 1.02 (0.72–1.44) | |
| Life-threatening bleeding | 19 (2.5%) | 18 (2.4%) | 1.06 (0.56–2.02) | |
| Major bleeding | 50 (6.7%) | 48 (6.4%) | 1.07 (0.72–1.59) | |
| Minor bleeding (BARC 2 or 3a) | 70 (9.3%) | 78 (10.4%) | 0.91 (0.66–1.26) | |
| Any bleeding | 174 (23.2%) | 170 (22.6%) | 1.05 (0.85–1.30) | |
BARC, Bleeding Academic Research Consortium; MI, myocardial infarction; TIA, transient ischaemic attack.
Life-threatening (including fatal) or disabling or major bleeding (BARC 4, 3a, 3b, and 3c), as defined by the Valve Academic Research Consortium-2 (VARC-2).
Death, myocardial infarction, stroke or TIA or systemic embolism, intracardiac or bioprosthesis thrombosis, episode of deep vein thrombosis or pulmonary embolism, life-threatening or disabling bleeding or major bleeding (primary endpoint).
Obstructive valve thrombosis was defined as the mean transprosthetic gradient ≥10 mmHg change from baseline (vs. hospital discharge) or > 20 mmHg or reduced leaflet mobility Grade 3 or 4 on at least one leaflet.
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