Author . | Region . | Enrolled period . | Data source . | Primary statistical method . | Number of patients treated with rivaroxabana . | Number of patients treated with rivaroxaban eligible for J-ROCKET AFa . | Number of patients treated with rivaroxaban eligible for ROCKET AFa . | Number of patients treated with rivaroxaban 10 mg despite of CrCl > 50 mL/mina . | Number of patients treated with rivaroxaban 20 mg despite of CrCl < 50 mL/mina . |
---|---|---|---|---|---|---|---|---|---|
Amarenco et al. 20196 | Europe, Canada, Israel | 2012–2013 | The XANTUS (prospective) | MLR | 6784 | 583 | 3608 | NR | 232 |
Atarashi et al. 20217 | Japan | 2013–2014 | The EXPAND (prospective) | PSM | 6806 | 5089 | 108 | 1609 | NR |
Kim et al. 20218 | Korea | 2012–2017 | Hospital-based electrical medical database (retrospective) | PSM | 283 | 177 | 106 | NR | NR |
Yagi et al. 20209 | Japan | 2012–2017 | Hospital-based electrical medical database (retrospective) | Not adjusted | 631 | 500 | 8 | 123 | NR |
Cho et al. 202010 | Korea | 2015–2016 | National Health Insurance Service database (retrospective) | IPTW | 9639 | 4879 | 4760 | NR | NR |
González-Pérez et al. 202211 | UK | 2012–2018 | IQVIA Medical Research Data UK database (retrospective) | MLR | 14 284 | 888 | 12 590 | NR | 806 |
Alcusky et al. 202012 | USA | 2011–2016 | Medicare beneficiaries database (retrospective) | MLR | 3735 | 1647 | 1658 | NR | 430 |
Ikeda et al. 201915 | Japan | 2012–2014 | The XAPASS (prospective) | IPTW | 6521 | 4185 | NR | 2336 | NR |
Yu et al. 202016 | Korea | 2013–2016 | National Health Insurance Service database (retrospective) | MLR | 20 143 | 5426 | 12 332 | NR | 2385 |
Arashi et al. 202017 | Japan | 2015–2017 | The AFIRE (prospective) | PSM | 1378 | 1022 | NR | 356 | NR |
Briasoulis et al. 202018 | USA | 2010–2016 | Medicare beneficiaries database (retrospective) | PSM | 19 712 | 2551 | 13 257 | NR | 3904 |
Lee et al. 201919 | Korea | 2014–2016 | National Health Insurance Service database (retrospective) | PSM | 13 594 | 5796 | 7798 | NR | NR |
Xu et al. 202220 | China | 2016–2020 | Hospital-based electrical medical database (retrospective) | PSM | 1227 | 890 | 337 | NR | NR |
Yao et al. 201721 | USA | 2010–2015 | OptumLabs Data Warehouse (retrospective) | PSM | 6428 | 815 | 5188 | NR | 425 |
Ashraf et al. 202122 | USA | 2001–2017 | Hospital-based electrical medical database (retrospective) | MLR | 2518 | 440 | 2078 | NR | NR |
Chan et al. 202023 | Taiwan | 2012–2018 | Hospital-based electrical medical database (retrospective) | MLR | 5135 | 2837 | 1354 | 858 | 86 |
Cheng et al. 202124 | Taiwan | 2012–2016 | Hospital-based electrical medical database (retrospective) | MLR | 2214 | 1373 | 257 | 584 | NR |
Fernandez et al. 202125 | Spain | 2016–2019 | The EMIR (prospective) | MLR | 1421 | 138 | 1183 | NR | 100 |
NR, not reported; APT, antiplatelet agent; BMI, body mass index; CHA2DS2-VASc, congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, previous stroke/transient ischaemic attack, vascular disease, age 65 to 74 years, female; CKD, chronic kidney disease; CrCl, creatinine clearance rate; HAS-BLED, hypertension, abnormal renal or liver function, stroke, bleeding history, labile INR, age 65 years or older, and antiplatelet drug or alcohol use; IPTW, inverse probability of treatment weighting; MLR, multivariable logistic regression; PSM, propensity score matching; sCr, serum creatinine. aCrude patient number before adjustment. |
Author . | Region . | Enrolled period . | Data source . | Primary statistical method . | Number of patients treated with rivaroxabana . | Number of patients treated with rivaroxaban eligible for J-ROCKET AFa . | Number of patients treated with rivaroxaban eligible for ROCKET AFa . | Number of patients treated with rivaroxaban 10 mg despite of CrCl > 50 mL/mina . | Number of patients treated with rivaroxaban 20 mg despite of CrCl < 50 mL/mina . |
---|---|---|---|---|---|---|---|---|---|
Amarenco et al. 20196 | Europe, Canada, Israel | 2012–2013 | The XANTUS (prospective) | MLR | 6784 | 583 | 3608 | NR | 232 |
Atarashi et al. 20217 | Japan | 2013–2014 | The EXPAND (prospective) | PSM | 6806 | 5089 | 108 | 1609 | NR |
Kim et al. 20218 | Korea | 2012–2017 | Hospital-based electrical medical database (retrospective) | PSM | 283 | 177 | 106 | NR | NR |
Yagi et al. 20209 | Japan | 2012–2017 | Hospital-based electrical medical database (retrospective) | Not adjusted | 631 | 500 | 8 | 123 | NR |
Cho et al. 202010 | Korea | 2015–2016 | National Health Insurance Service database (retrospective) | IPTW | 9639 | 4879 | 4760 | NR | NR |
González-Pérez et al. 202211 | UK | 2012–2018 | IQVIA Medical Research Data UK database (retrospective) | MLR | 14 284 | 888 | 12 590 | NR | 806 |
Alcusky et al. 202012 | USA | 2011–2016 | Medicare beneficiaries database (retrospective) | MLR | 3735 | 1647 | 1658 | NR | 430 |
Ikeda et al. 201915 | Japan | 2012–2014 | The XAPASS (prospective) | IPTW | 6521 | 4185 | NR | 2336 | NR |
Yu et al. 202016 | Korea | 2013–2016 | National Health Insurance Service database (retrospective) | MLR | 20 143 | 5426 | 12 332 | NR | 2385 |
Arashi et al. 202017 | Japan | 2015–2017 | The AFIRE (prospective) | PSM | 1378 | 1022 | NR | 356 | NR |
Briasoulis et al. 202018 | USA | 2010–2016 | Medicare beneficiaries database (retrospective) | PSM | 19 712 | 2551 | 13 257 | NR | 3904 |
Lee et al. 201919 | Korea | 2014–2016 | National Health Insurance Service database (retrospective) | PSM | 13 594 | 5796 | 7798 | NR | NR |
Xu et al. 202220 | China | 2016–2020 | Hospital-based electrical medical database (retrospective) | PSM | 1227 | 890 | 337 | NR | NR |
Yao et al. 201721 | USA | 2010–2015 | OptumLabs Data Warehouse (retrospective) | PSM | 6428 | 815 | 5188 | NR | 425 |
Ashraf et al. 202122 | USA | 2001–2017 | Hospital-based electrical medical database (retrospective) | MLR | 2518 | 440 | 2078 | NR | NR |
Chan et al. 202023 | Taiwan | 2012–2018 | Hospital-based electrical medical database (retrospective) | MLR | 5135 | 2837 | 1354 | 858 | 86 |
Cheng et al. 202124 | Taiwan | 2012–2016 | Hospital-based electrical medical database (retrospective) | MLR | 2214 | 1373 | 257 | 584 | NR |
Fernandez et al. 202125 | Spain | 2016–2019 | The EMIR (prospective) | MLR | 1421 | 138 | 1183 | NR | 100 |
NR, not reported; APT, antiplatelet agent; BMI, body mass index; CHA2DS2-VASc, congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, previous stroke/transient ischaemic attack, vascular disease, age 65 to 74 years, female; CKD, chronic kidney disease; CrCl, creatinine clearance rate; HAS-BLED, hypertension, abnormal renal or liver function, stroke, bleeding history, labile INR, age 65 years or older, and antiplatelet drug or alcohol use; IPTW, inverse probability of treatment weighting; MLR, multivariable logistic regression; PSM, propensity score matching; sCr, serum creatinine. aCrude patient number before adjustment. |
Author . | Age (mean) . | Female (%) . | Body weight (kg) . | BMI (kg/m2) . | CrCl (mL/min) . | CKD or CrCl < 50 . | CHA2DS2-VASc . | HAS-BLED . | Bleeding history . | Heart failure . | Hypertension . | Diabetes . | Stroke or TIA . | Vascular disease . | Dyslipidaemia . | Use of APT . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amarenco et al. 20196 | 71.5 | 41 | 83.0 | 28.2 | NR | 9% | 3.4 | NR | NR | 19% | 75% | 20% | 19% | 10% | NR | 18% |
Atarashi et al. 20217 | 71.6 | 32 | 62.7 | NR | NR | 22% | 3.4 | 1.4 | 4% | 27% | 71% | 25% | 24% | 4% | 42% | 9% |
Kim et al. 20218 | 72.5 | 45 | NR | NR | NR | NR | 3.3 | NR | NR | 9% | 63% | 24% | 20% | 11% | NR | NR |
Yagi et al. 20209 | 69.1 | 22 | 67.1 | NR | 75.4 | 16% | 2.2 | 1.5 | NR | 17% | 54% | 16% | 6% | 5% | 31% | 11% |
Cho et al. 202010 | 69.8 | 40 | NR | 25.5 | 72.7 | 2% | 3.3 | 2.4 | NR | 19% | 89% | 47% | 2% | 11% | NR | 9% |
González-Pérez et al. 202211 | 74.9 | 43 | NR | NR | NR | 42% | 3.4 | 1.7 | 27% | 16% | 67% | NR | 13% | 27% | NR | 46% |
Alcusky et al. 202012 | 84 | 69 | NR | NR | NR | 19% | 5 | 3* | NR | 33% | 84% | 35% | 23% | 26% | NR | 23% |
Ikeda et al. 201915 | 69.5 | 31 | 65.3 | 24.8 | 78.8 | 0% | 3.1 | 1.3 | NR | 21% | 74% | 23% | 21% | 3% | NR | 13% |
Yu et al. 202016 | 70.5 | 40 | NR | NR | NR | 8% | 4.6 | NR | NR | 61% | 96% | 32% | 46% | 29% | 92% | 16% |
Arashi et al. 202017 | 71.4 | 14 | 68.6 | 25.4 | 74.3 | 0% | 3.7 | 2.1 | 1% | 30% | 87% | 45% | 13% | 34% | 71% | 36% |
Briasoulis et al. 202018 | NR | 50 | NR | NR | NR | 47% | NR | NR | 25% | 28% | 93% | 49% | 24% | 43% | NR | 26% |
Lee et al. 201919 | 71.2 | 45 | 63.8 | 24.7 | 82.3 | 0% | 3.5 | NR | 0% | 30% | 72% | 22% | 0% | 3% | 42% | NR |
Xu et al. 202220 | 64.2 | 43 | 65.8 | NR | 75.8 | NR | 2.1 | 1.3 | NR | 5% | 81% | 26% | 2% | 7% | NR | NR |
Yao et al. 201721 | 70.6 | 43 | NR | NR | 69.9 | 17% | NR | NR | 11% | 40% | 90% | 42% | 14% | 28% | 82% | 8% |
Ashraf et al. 202122 | 73.8 | 44 | NR | 30.6 | sCr: 1.1 | 17% | 3.7 | 2.4+ | NR | NR | 83% | 28% | 22% | 29% | 66% | NR |
Chan et al. 202023 | 74.2 | 42 | 65.4 | NR | 60.9 | 25% | 3.5 | 2.8 | NR | 11% | 75% | 34% | 17% | 12% | 43% | 54% |
Cheng et al. 202124 | 75.7 | 36 | NR | NR | 71.3 | NR | 2.9 | NR | 8% | 25% | 57% | 22% | 2% | 9% | NR | 24% |
Fernandez et al. 202125 | 74.2 | 44 | 79.7 | 29.1 | 76.0 | 16% | 3.5 | 1.6 | 3% | 23% | 79% | 27% | 13% | 17% | 55% | 8% |
Author . | Age (mean) . | Female (%) . | Body weight (kg) . | BMI (kg/m2) . | CrCl (mL/min) . | CKD or CrCl < 50 . | CHA2DS2-VASc . | HAS-BLED . | Bleeding history . | Heart failure . | Hypertension . | Diabetes . | Stroke or TIA . | Vascular disease . | Dyslipidaemia . | Use of APT . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amarenco et al. 20196 | 71.5 | 41 | 83.0 | 28.2 | NR | 9% | 3.4 | NR | NR | 19% | 75% | 20% | 19% | 10% | NR | 18% |
Atarashi et al. 20217 | 71.6 | 32 | 62.7 | NR | NR | 22% | 3.4 | 1.4 | 4% | 27% | 71% | 25% | 24% | 4% | 42% | 9% |
Kim et al. 20218 | 72.5 | 45 | NR | NR | NR | NR | 3.3 | NR | NR | 9% | 63% | 24% | 20% | 11% | NR | NR |
Yagi et al. 20209 | 69.1 | 22 | 67.1 | NR | 75.4 | 16% | 2.2 | 1.5 | NR | 17% | 54% | 16% | 6% | 5% | 31% | 11% |
Cho et al. 202010 | 69.8 | 40 | NR | 25.5 | 72.7 | 2% | 3.3 | 2.4 | NR | 19% | 89% | 47% | 2% | 11% | NR | 9% |
González-Pérez et al. 202211 | 74.9 | 43 | NR | NR | NR | 42% | 3.4 | 1.7 | 27% | 16% | 67% | NR | 13% | 27% | NR | 46% |
Alcusky et al. 202012 | 84 | 69 | NR | NR | NR | 19% | 5 | 3* | NR | 33% | 84% | 35% | 23% | 26% | NR | 23% |
Ikeda et al. 201915 | 69.5 | 31 | 65.3 | 24.8 | 78.8 | 0% | 3.1 | 1.3 | NR | 21% | 74% | 23% | 21% | 3% | NR | 13% |
Yu et al. 202016 | 70.5 | 40 | NR | NR | NR | 8% | 4.6 | NR | NR | 61% | 96% | 32% | 46% | 29% | 92% | 16% |
Arashi et al. 202017 | 71.4 | 14 | 68.6 | 25.4 | 74.3 | 0% | 3.7 | 2.1 | 1% | 30% | 87% | 45% | 13% | 34% | 71% | 36% |
Briasoulis et al. 202018 | NR | 50 | NR | NR | NR | 47% | NR | NR | 25% | 28% | 93% | 49% | 24% | 43% | NR | 26% |
Lee et al. 201919 | 71.2 | 45 | 63.8 | 24.7 | 82.3 | 0% | 3.5 | NR | 0% | 30% | 72% | 22% | 0% | 3% | 42% | NR |
Xu et al. 202220 | 64.2 | 43 | 65.8 | NR | 75.8 | NR | 2.1 | 1.3 | NR | 5% | 81% | 26% | 2% | 7% | NR | NR |
Yao et al. 201721 | 70.6 | 43 | NR | NR | 69.9 | 17% | NR | NR | 11% | 40% | 90% | 42% | 14% | 28% | 82% | 8% |
Ashraf et al. 202122 | 73.8 | 44 | NR | 30.6 | sCr: 1.1 | 17% | 3.7 | 2.4+ | NR | NR | 83% | 28% | 22% | 29% | 66% | NR |
Chan et al. 202023 | 74.2 | 42 | 65.4 | NR | 60.9 | 25% | 3.5 | 2.8 | NR | 11% | 75% | 34% | 17% | 12% | 43% | 54% |
Cheng et al. 202124 | 75.7 | 36 | NR | NR | 71.3 | NR | 2.9 | NR | 8% | 25% | 57% | 22% | 2% | 9% | NR | 24% |
Fernandez et al. 202125 | 74.2 | 44 | 79.7 | 29.1 | 76.0 | 16% | 3.5 | 1.6 | 3% | 23% | 79% | 27% | 13% | 17% | 55% | 8% |
Author . | IS/SEa (rate per 100 PYs) . | Mortalitya (rate per 100 PYs) . | Major bleedinga (rate per 100 PYs) . |
---|---|---|---|
Amarenco et al. 20196 | 1.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 1.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.6 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) |
2.7 (15 mg if CrCl > 50; J-ROCKET AF) | 3.1 (15 mg if CrCl > 50; J-ROCKET AF) | 3.9 (15 mg if CrCl > 50; J-ROCKET AF) | |
2.9 (20 mg if CrCl < 50) | 3.8 (20 mg if CrCl < 50) | 2.9 (20 mg if CrCl < 50) | |
Atarashi et al. 20217 | 1.57 (15 mg if CrCl < 50; ROCKET AF) | 5.09 (15 mg if CrCl < 50; ROCKET AF) | 3.53 (15 mg if CrCl < 50; ROCKET AF) |
0.83 (15 mg if CrCl > 50; J-ROCKET AF) | 0.75 (15 mg if CrCl > 50; J-ROCKET AF) | 1.01 (15 mg if CrCl > 50; J-ROCKET AF) | |
1.46 (10 mg if CrCl < 50; J-ROCKET AF) | 3.69 (10 mg if CrCl < 50; J-RCOKET AF) | 1.80 (10 mg if CrCl < 50; J-ROCKET AF) | |
0.88 (10 mg if CrCl > 50) | 1.67 (10 mg if CrCl > 50) | 1.13 (10 mg if CrCl > 50) | |
Kim et al. 20218 | 1.9 (20 mg if CrCl > 50; ROCKET AF) | 0.9 (20 mg if CrCl > 50; ROCKET AF) | 0.9 (20 mg if CrCl > 50; ROCKET AF) |
2.8 (15 mg if CrCl > 50; J-ROCKET AF) | 1.7 (15 mg if CrCl > 50; J-ROCKET AF) | 2.3 (15 mg if CrCl > 50; J-ROCKET AF) | |
Yagi et al. 20209 | 0.0 (15 mg if CrCl < 50; ROCKET AF) | 0.0 (15 mg if CrCl < 50; ROCKET AF) | 0.0 (15 mg if CrCl < 50; ROCKET AF) |
0.1 (15 mg if CrCl > 50; J-ROCKET AF) | 0.3 (15 mg if CrCl > 50; J-ROCKET AF) | 0.7 (15 mg if CrCl > 50; J-ROCKET AF) | |
0.0 (10 mg if CrCl < 50; J-ROCKET AF) | 0.9 (10 mg if CrCl < 50; J-ROCKET AF) | 1.9 (10 mg if CrCl < 50; J-ROCKET AF) | |
0.0 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | |
Cho et al. 202010 | 2.0 (20 mg if CrCl > 50; ROCKET AF) | 1.7 (20 mg if CrCl > 50; ROCKET AF) | 1.7 (20 mg if CrCl > 50; ROCKET AF) |
2.5 (15 mg if CrCl > 50; J-ROCKET AF) | 1.9 (15 mg if CrCl > 50; J-ROCKET AF) | 2.2 (15 mg if CrCl > 50; J-ROCKET AF) | |
González-Pérez et al. 202211 | 1.7 (20 mg if CrCl < 50; overdosing)d | 19.4 (20 mg if CrCl < 50; overdosing)d | NR |
1.1 (20 mg if CrCl > 50; ROCKET AF)d | 7.3 (20 mg if CrCl > 50; ROCKET AF)d | ||
1.5 (15 mg if CrCl < 50; ROCKET AF)d | 23.1 (15 mg if CrCl < 50; ROCKET AF)d | ||
2.4 (15 mg if CrCl > 50; J-ROCKET AF)d | 32.0 (15 mg if CrCl > 50; J-ROCKET AF)d | ||
Alcusky et al. 202012 | 1.75 (2011–2013)b | 28.18 (2011–2013)b | 6.22 (2011–2013)b |
1.89 (2014–2016)b | 31.17 (2014–2016)b | 6.58 (2014–2016)b | |
Ikeda et al. 201915 | 1.5 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF)c | NR | 1.6 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF)c |
2.2 (10 mg if CrCl > 50)c | 1.3 (10 mg if CrCl > 50)c | ||
Yu et al. 202016 | 5.8 (20 mg if CrCl < 50) | 5.4 (20 mg if CrCl < 50) | 4.8 (20 mg if CrCl < 50) |
4.0 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 3.1 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
4.0 (15 if CrCl > 50; J-ROCKET AF) | 3.2 (15 if CrCl > 50; J-ROCKET AF) | 3.0 (15 if CrCl > 50; J-ROCKET AF) | |
Arashi et al. 202017 | 1.1 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 1.4 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 2.2 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) |
0.7 (10 mg if CrCl > 50) | 1.6 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | |
Briasoulis et al. 202018 | 4.3 (20 mg if CrCl < 50) | NR | 7.9 (20 mg if CrCl < 50) |
2.6 (20 mg if CrCl > 50; ROCKET AF) | 4.3 (20 mg if CrCl > 50; ROCKET AF) | ||
5.7 (15 mg if CrCl < 50; ROCKET AF) | 9.9 (15 mg if CrCl < 50; ROCKET AF) | ||
4.0 (15 mg if CrCl > 50; J-ROCKET AF) | 6.7 (15 mg if CrCl > 50; J-ROCKET AF) | ||
Lee et al. 201919 | 2.2 (20 mg if CrCl > 50; ROCKET AF)c | 3.6 (20 mg if CrCl > 50; ROCKET AF)c | 2.3 (20 mg if CrCl > 50; ROCKET AF)c |
2.6 (15 mg if CrCl > 50; J-ROCKET AF)c | 4.3 (15 mg if CrCl > 50; J-ROCKET AF)c | 2.7 (15 mg if CrCl > 50; J-ROCKET AF)c | |
Xu et al. 202220 | 0.6 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d | 9.2 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d | 2.4 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d |
1.8 (15 if CrCl > 50; J-ROCKET AF)d | 2.9 (15 if CrCl > 50; J-ROCKET AF)d | 0.2 (15 if CrCl > 50; J-ROCKET AF)d | |
Yao et al. 201721 | 2.8 (20 mg if CrCl < 50)c | NR | 11.0 (20 mg if CrCl < 50)c |
1.7 (20 mg if CrCl > 50; ROCKET AF)c | 4.9 (20 mg if CrCl > 50; ROCKET AF)c | ||
1.2 (15 mg if CrCl < 50; ROCKET AF)c | 5.9 (15 mg if CrCl < 50; ROCKET AF)c | ||
1.2 (15 mg if CrCl > 50; J-ROCKET AF)c | 5.4 (15 mg if CrCl > 50; J-ROCKET AF)c | ||
Ashraf et al. 202122 | 18.9 for 5 years (on-label)d,e | 13.0 for 5 years (on-label)d,e | 8.3 for 5 years (on-label)d,e |
22.4 for 5 years (underdosing)d,e | 18.7 for 5 years (underdosing)d,e | 10.2 for 5 years (underdosing)d,e | |
Chan et al. 202023 | 4.3 (20 mg if CrCl < 50) | 4.5 (20 mg if CrCl < 50) | 2.4 (20 mg if CrCl < 50) |
2.0 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 7.8 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 1.3 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
1.4 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 4.8 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 0.7 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | |
2.7 (10 mg if CrCl > 50) | 4.5 (10 mg if CrCl < 50) | 0.5 (10 mg if CrCl < 50) | |
Cheng et al. 202124 | 0.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF or | NR | NR |
15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | |||
2.8 (10 mg if CrCl > 50) | |||
Fernandez et al. 202125 | 1.1 (20 mg if CrCl < 50) | 3.4 (20 mg if CrCl < 50) | 2.3 (20 mg if CrCl < 50) |
0.5 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.3 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 0.8 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
0.4 (15 if CrCl > 50; J-ROCKET AF) | 5.8 (15 if CrCl > 50; J-ROCKET AF) | 1.3 (15 if CrCl > 50; J-ROCKET AF) |
Author . | IS/SEa (rate per 100 PYs) . | Mortalitya (rate per 100 PYs) . | Major bleedinga (rate per 100 PYs) . |
---|---|---|---|
Amarenco et al. 20196 | 1.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 1.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.6 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) |
2.7 (15 mg if CrCl > 50; J-ROCKET AF) | 3.1 (15 mg if CrCl > 50; J-ROCKET AF) | 3.9 (15 mg if CrCl > 50; J-ROCKET AF) | |
2.9 (20 mg if CrCl < 50) | 3.8 (20 mg if CrCl < 50) | 2.9 (20 mg if CrCl < 50) | |
Atarashi et al. 20217 | 1.57 (15 mg if CrCl < 50; ROCKET AF) | 5.09 (15 mg if CrCl < 50; ROCKET AF) | 3.53 (15 mg if CrCl < 50; ROCKET AF) |
0.83 (15 mg if CrCl > 50; J-ROCKET AF) | 0.75 (15 mg if CrCl > 50; J-ROCKET AF) | 1.01 (15 mg if CrCl > 50; J-ROCKET AF) | |
1.46 (10 mg if CrCl < 50; J-ROCKET AF) | 3.69 (10 mg if CrCl < 50; J-RCOKET AF) | 1.80 (10 mg if CrCl < 50; J-ROCKET AF) | |
0.88 (10 mg if CrCl > 50) | 1.67 (10 mg if CrCl > 50) | 1.13 (10 mg if CrCl > 50) | |
Kim et al. 20218 | 1.9 (20 mg if CrCl > 50; ROCKET AF) | 0.9 (20 mg if CrCl > 50; ROCKET AF) | 0.9 (20 mg if CrCl > 50; ROCKET AF) |
2.8 (15 mg if CrCl > 50; J-ROCKET AF) | 1.7 (15 mg if CrCl > 50; J-ROCKET AF) | 2.3 (15 mg if CrCl > 50; J-ROCKET AF) | |
Yagi et al. 20209 | 0.0 (15 mg if CrCl < 50; ROCKET AF) | 0.0 (15 mg if CrCl < 50; ROCKET AF) | 0.0 (15 mg if CrCl < 50; ROCKET AF) |
0.1 (15 mg if CrCl > 50; J-ROCKET AF) | 0.3 (15 mg if CrCl > 50; J-ROCKET AF) | 0.7 (15 mg if CrCl > 50; J-ROCKET AF) | |
0.0 (10 mg if CrCl < 50; J-ROCKET AF) | 0.9 (10 mg if CrCl < 50; J-ROCKET AF) | 1.9 (10 mg if CrCl < 50; J-ROCKET AF) | |
0.0 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | |
Cho et al. 202010 | 2.0 (20 mg if CrCl > 50; ROCKET AF) | 1.7 (20 mg if CrCl > 50; ROCKET AF) | 1.7 (20 mg if CrCl > 50; ROCKET AF) |
2.5 (15 mg if CrCl > 50; J-ROCKET AF) | 1.9 (15 mg if CrCl > 50; J-ROCKET AF) | 2.2 (15 mg if CrCl > 50; J-ROCKET AF) | |
González-Pérez et al. 202211 | 1.7 (20 mg if CrCl < 50; overdosing)d | 19.4 (20 mg if CrCl < 50; overdosing)d | NR |
1.1 (20 mg if CrCl > 50; ROCKET AF)d | 7.3 (20 mg if CrCl > 50; ROCKET AF)d | ||
1.5 (15 mg if CrCl < 50; ROCKET AF)d | 23.1 (15 mg if CrCl < 50; ROCKET AF)d | ||
2.4 (15 mg if CrCl > 50; J-ROCKET AF)d | 32.0 (15 mg if CrCl > 50; J-ROCKET AF)d | ||
Alcusky et al. 202012 | 1.75 (2011–2013)b | 28.18 (2011–2013)b | 6.22 (2011–2013)b |
1.89 (2014–2016)b | 31.17 (2014–2016)b | 6.58 (2014–2016)b | |
Ikeda et al. 201915 | 1.5 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF)c | NR | 1.6 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF)c |
2.2 (10 mg if CrCl > 50)c | 1.3 (10 mg if CrCl > 50)c | ||
Yu et al. 202016 | 5.8 (20 mg if CrCl < 50) | 5.4 (20 mg if CrCl < 50) | 4.8 (20 mg if CrCl < 50) |
4.0 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 3.1 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
4.0 (15 if CrCl > 50; J-ROCKET AF) | 3.2 (15 if CrCl > 50; J-ROCKET AF) | 3.0 (15 if CrCl > 50; J-ROCKET AF) | |
Arashi et al. 202017 | 1.1 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 1.4 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 2.2 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) |
0.7 (10 mg if CrCl > 50) | 1.6 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | |
Briasoulis et al. 202018 | 4.3 (20 mg if CrCl < 50) | NR | 7.9 (20 mg if CrCl < 50) |
2.6 (20 mg if CrCl > 50; ROCKET AF) | 4.3 (20 mg if CrCl > 50; ROCKET AF) | ||
5.7 (15 mg if CrCl < 50; ROCKET AF) | 9.9 (15 mg if CrCl < 50; ROCKET AF) | ||
4.0 (15 mg if CrCl > 50; J-ROCKET AF) | 6.7 (15 mg if CrCl > 50; J-ROCKET AF) | ||
Lee et al. 201919 | 2.2 (20 mg if CrCl > 50; ROCKET AF)c | 3.6 (20 mg if CrCl > 50; ROCKET AF)c | 2.3 (20 mg if CrCl > 50; ROCKET AF)c |
2.6 (15 mg if CrCl > 50; J-ROCKET AF)c | 4.3 (15 mg if CrCl > 50; J-ROCKET AF)c | 2.7 (15 mg if CrCl > 50; J-ROCKET AF)c | |
Xu et al. 202220 | 0.6 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d | 9.2 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d | 2.4 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d |
1.8 (15 if CrCl > 50; J-ROCKET AF)d | 2.9 (15 if CrCl > 50; J-ROCKET AF)d | 0.2 (15 if CrCl > 50; J-ROCKET AF)d | |
Yao et al. 201721 | 2.8 (20 mg if CrCl < 50)c | NR | 11.0 (20 mg if CrCl < 50)c |
1.7 (20 mg if CrCl > 50; ROCKET AF)c | 4.9 (20 mg if CrCl > 50; ROCKET AF)c | ||
1.2 (15 mg if CrCl < 50; ROCKET AF)c | 5.9 (15 mg if CrCl < 50; ROCKET AF)c | ||
1.2 (15 mg if CrCl > 50; J-ROCKET AF)c | 5.4 (15 mg if CrCl > 50; J-ROCKET AF)c | ||
Ashraf et al. 202122 | 18.9 for 5 years (on-label)d,e | 13.0 for 5 years (on-label)d,e | 8.3 for 5 years (on-label)d,e |
22.4 for 5 years (underdosing)d,e | 18.7 for 5 years (underdosing)d,e | 10.2 for 5 years (underdosing)d,e | |
Chan et al. 202023 | 4.3 (20 mg if CrCl < 50) | 4.5 (20 mg if CrCl < 50) | 2.4 (20 mg if CrCl < 50) |
2.0 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 7.8 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 1.3 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
1.4 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 4.8 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 0.7 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | |
2.7 (10 mg if CrCl > 50) | 4.5 (10 mg if CrCl < 50) | 0.5 (10 mg if CrCl < 50) | |
Cheng et al. 202124 | 0.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF or | NR | NR |
15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | |||
2.8 (10 mg if CrCl > 50) | |||
Fernandez et al. 202125 | 1.1 (20 mg if CrCl < 50) | 3.4 (20 mg if CrCl < 50) | 2.3 (20 mg if CrCl < 50) |
0.5 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.3 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 0.8 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
0.4 (15 if CrCl > 50; J-ROCKET AF) | 5.8 (15 if CrCl > 50; J-ROCKET AF) | 1.3 (15 if CrCl > 50; J-ROCKET AF) |
IS/SE, ischemic stroke/systemic embolism; PY, patient-year; TIA, transient ischemic attack.
aCrude annual incidence rate before adjustment.
bNot reporting annual incidence rate for patients treated with on-labelling, underdosing, and overdosing rivaroxaban individually.
cOnly reporting annual incidence rate after adjustment.
dOnly reporting overall incidence rate without annual adjustment.
eNot reporting annual incidence rate for rivaroxaban, dabigatran, or apixaban individually.
*ATRIA bleeding score.
Author . | Region . | Enrolled period . | Data source . | Primary statistical method . | Number of patients treated with rivaroxabana . | Number of patients treated with rivaroxaban eligible for J-ROCKET AFa . | Number of patients treated with rivaroxaban eligible for ROCKET AFa . | Number of patients treated with rivaroxaban 10 mg despite of CrCl > 50 mL/mina . | Number of patients treated with rivaroxaban 20 mg despite of CrCl < 50 mL/mina . |
---|---|---|---|---|---|---|---|---|---|
Amarenco et al. 20196 | Europe, Canada, Israel | 2012–2013 | The XANTUS (prospective) | MLR | 6784 | 583 | 3608 | NR | 232 |
Atarashi et al. 20217 | Japan | 2013–2014 | The EXPAND (prospective) | PSM | 6806 | 5089 | 108 | 1609 | NR |
Kim et al. 20218 | Korea | 2012–2017 | Hospital-based electrical medical database (retrospective) | PSM | 283 | 177 | 106 | NR | NR |
Yagi et al. 20209 | Japan | 2012–2017 | Hospital-based electrical medical database (retrospective) | Not adjusted | 631 | 500 | 8 | 123 | NR |
Cho et al. 202010 | Korea | 2015–2016 | National Health Insurance Service database (retrospective) | IPTW | 9639 | 4879 | 4760 | NR | NR |
González-Pérez et al. 202211 | UK | 2012–2018 | IQVIA Medical Research Data UK database (retrospective) | MLR | 14 284 | 888 | 12 590 | NR | 806 |
Alcusky et al. 202012 | USA | 2011–2016 | Medicare beneficiaries database (retrospective) | MLR | 3735 | 1647 | 1658 | NR | 430 |
Ikeda et al. 201915 | Japan | 2012–2014 | The XAPASS (prospective) | IPTW | 6521 | 4185 | NR | 2336 | NR |
Yu et al. 202016 | Korea | 2013–2016 | National Health Insurance Service database (retrospective) | MLR | 20 143 | 5426 | 12 332 | NR | 2385 |
Arashi et al. 202017 | Japan | 2015–2017 | The AFIRE (prospective) | PSM | 1378 | 1022 | NR | 356 | NR |
Briasoulis et al. 202018 | USA | 2010–2016 | Medicare beneficiaries database (retrospective) | PSM | 19 712 | 2551 | 13 257 | NR | 3904 |
Lee et al. 201919 | Korea | 2014–2016 | National Health Insurance Service database (retrospective) | PSM | 13 594 | 5796 | 7798 | NR | NR |
Xu et al. 202220 | China | 2016–2020 | Hospital-based electrical medical database (retrospective) | PSM | 1227 | 890 | 337 | NR | NR |
Yao et al. 201721 | USA | 2010–2015 | OptumLabs Data Warehouse (retrospective) | PSM | 6428 | 815 | 5188 | NR | 425 |
Ashraf et al. 202122 | USA | 2001–2017 | Hospital-based electrical medical database (retrospective) | MLR | 2518 | 440 | 2078 | NR | NR |
Chan et al. 202023 | Taiwan | 2012–2018 | Hospital-based electrical medical database (retrospective) | MLR | 5135 | 2837 | 1354 | 858 | 86 |
Cheng et al. 202124 | Taiwan | 2012–2016 | Hospital-based electrical medical database (retrospective) | MLR | 2214 | 1373 | 257 | 584 | NR |
Fernandez et al. 202125 | Spain | 2016–2019 | The EMIR (prospective) | MLR | 1421 | 138 | 1183 | NR | 100 |
NR, not reported; APT, antiplatelet agent; BMI, body mass index; CHA2DS2-VASc, congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, previous stroke/transient ischaemic attack, vascular disease, age 65 to 74 years, female; CKD, chronic kidney disease; CrCl, creatinine clearance rate; HAS-BLED, hypertension, abnormal renal or liver function, stroke, bleeding history, labile INR, age 65 years or older, and antiplatelet drug or alcohol use; IPTW, inverse probability of treatment weighting; MLR, multivariable logistic regression; PSM, propensity score matching; sCr, serum creatinine. aCrude patient number before adjustment. |
Author . | Region . | Enrolled period . | Data source . | Primary statistical method . | Number of patients treated with rivaroxabana . | Number of patients treated with rivaroxaban eligible for J-ROCKET AFa . | Number of patients treated with rivaroxaban eligible for ROCKET AFa . | Number of patients treated with rivaroxaban 10 mg despite of CrCl > 50 mL/mina . | Number of patients treated with rivaroxaban 20 mg despite of CrCl < 50 mL/mina . |
---|---|---|---|---|---|---|---|---|---|
Amarenco et al. 20196 | Europe, Canada, Israel | 2012–2013 | The XANTUS (prospective) | MLR | 6784 | 583 | 3608 | NR | 232 |
Atarashi et al. 20217 | Japan | 2013–2014 | The EXPAND (prospective) | PSM | 6806 | 5089 | 108 | 1609 | NR |
Kim et al. 20218 | Korea | 2012–2017 | Hospital-based electrical medical database (retrospective) | PSM | 283 | 177 | 106 | NR | NR |
Yagi et al. 20209 | Japan | 2012–2017 | Hospital-based electrical medical database (retrospective) | Not adjusted | 631 | 500 | 8 | 123 | NR |
Cho et al. 202010 | Korea | 2015–2016 | National Health Insurance Service database (retrospective) | IPTW | 9639 | 4879 | 4760 | NR | NR |
González-Pérez et al. 202211 | UK | 2012–2018 | IQVIA Medical Research Data UK database (retrospective) | MLR | 14 284 | 888 | 12 590 | NR | 806 |
Alcusky et al. 202012 | USA | 2011–2016 | Medicare beneficiaries database (retrospective) | MLR | 3735 | 1647 | 1658 | NR | 430 |
Ikeda et al. 201915 | Japan | 2012–2014 | The XAPASS (prospective) | IPTW | 6521 | 4185 | NR | 2336 | NR |
Yu et al. 202016 | Korea | 2013–2016 | National Health Insurance Service database (retrospective) | MLR | 20 143 | 5426 | 12 332 | NR | 2385 |
Arashi et al. 202017 | Japan | 2015–2017 | The AFIRE (prospective) | PSM | 1378 | 1022 | NR | 356 | NR |
Briasoulis et al. 202018 | USA | 2010–2016 | Medicare beneficiaries database (retrospective) | PSM | 19 712 | 2551 | 13 257 | NR | 3904 |
Lee et al. 201919 | Korea | 2014–2016 | National Health Insurance Service database (retrospective) | PSM | 13 594 | 5796 | 7798 | NR | NR |
Xu et al. 202220 | China | 2016–2020 | Hospital-based electrical medical database (retrospective) | PSM | 1227 | 890 | 337 | NR | NR |
Yao et al. 201721 | USA | 2010–2015 | OptumLabs Data Warehouse (retrospective) | PSM | 6428 | 815 | 5188 | NR | 425 |
Ashraf et al. 202122 | USA | 2001–2017 | Hospital-based electrical medical database (retrospective) | MLR | 2518 | 440 | 2078 | NR | NR |
Chan et al. 202023 | Taiwan | 2012–2018 | Hospital-based electrical medical database (retrospective) | MLR | 5135 | 2837 | 1354 | 858 | 86 |
Cheng et al. 202124 | Taiwan | 2012–2016 | Hospital-based electrical medical database (retrospective) | MLR | 2214 | 1373 | 257 | 584 | NR |
Fernandez et al. 202125 | Spain | 2016–2019 | The EMIR (prospective) | MLR | 1421 | 138 | 1183 | NR | 100 |
NR, not reported; APT, antiplatelet agent; BMI, body mass index; CHA2DS2-VASc, congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, previous stroke/transient ischaemic attack, vascular disease, age 65 to 74 years, female; CKD, chronic kidney disease; CrCl, creatinine clearance rate; HAS-BLED, hypertension, abnormal renal or liver function, stroke, bleeding history, labile INR, age 65 years or older, and antiplatelet drug or alcohol use; IPTW, inverse probability of treatment weighting; MLR, multivariable logistic regression; PSM, propensity score matching; sCr, serum creatinine. aCrude patient number before adjustment. |
Author . | Age (mean) . | Female (%) . | Body weight (kg) . | BMI (kg/m2) . | CrCl (mL/min) . | CKD or CrCl < 50 . | CHA2DS2-VASc . | HAS-BLED . | Bleeding history . | Heart failure . | Hypertension . | Diabetes . | Stroke or TIA . | Vascular disease . | Dyslipidaemia . | Use of APT . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amarenco et al. 20196 | 71.5 | 41 | 83.0 | 28.2 | NR | 9% | 3.4 | NR | NR | 19% | 75% | 20% | 19% | 10% | NR | 18% |
Atarashi et al. 20217 | 71.6 | 32 | 62.7 | NR | NR | 22% | 3.4 | 1.4 | 4% | 27% | 71% | 25% | 24% | 4% | 42% | 9% |
Kim et al. 20218 | 72.5 | 45 | NR | NR | NR | NR | 3.3 | NR | NR | 9% | 63% | 24% | 20% | 11% | NR | NR |
Yagi et al. 20209 | 69.1 | 22 | 67.1 | NR | 75.4 | 16% | 2.2 | 1.5 | NR | 17% | 54% | 16% | 6% | 5% | 31% | 11% |
Cho et al. 202010 | 69.8 | 40 | NR | 25.5 | 72.7 | 2% | 3.3 | 2.4 | NR | 19% | 89% | 47% | 2% | 11% | NR | 9% |
González-Pérez et al. 202211 | 74.9 | 43 | NR | NR | NR | 42% | 3.4 | 1.7 | 27% | 16% | 67% | NR | 13% | 27% | NR | 46% |
Alcusky et al. 202012 | 84 | 69 | NR | NR | NR | 19% | 5 | 3* | NR | 33% | 84% | 35% | 23% | 26% | NR | 23% |
Ikeda et al. 201915 | 69.5 | 31 | 65.3 | 24.8 | 78.8 | 0% | 3.1 | 1.3 | NR | 21% | 74% | 23% | 21% | 3% | NR | 13% |
Yu et al. 202016 | 70.5 | 40 | NR | NR | NR | 8% | 4.6 | NR | NR | 61% | 96% | 32% | 46% | 29% | 92% | 16% |
Arashi et al. 202017 | 71.4 | 14 | 68.6 | 25.4 | 74.3 | 0% | 3.7 | 2.1 | 1% | 30% | 87% | 45% | 13% | 34% | 71% | 36% |
Briasoulis et al. 202018 | NR | 50 | NR | NR | NR | 47% | NR | NR | 25% | 28% | 93% | 49% | 24% | 43% | NR | 26% |
Lee et al. 201919 | 71.2 | 45 | 63.8 | 24.7 | 82.3 | 0% | 3.5 | NR | 0% | 30% | 72% | 22% | 0% | 3% | 42% | NR |
Xu et al. 202220 | 64.2 | 43 | 65.8 | NR | 75.8 | NR | 2.1 | 1.3 | NR | 5% | 81% | 26% | 2% | 7% | NR | NR |
Yao et al. 201721 | 70.6 | 43 | NR | NR | 69.9 | 17% | NR | NR | 11% | 40% | 90% | 42% | 14% | 28% | 82% | 8% |
Ashraf et al. 202122 | 73.8 | 44 | NR | 30.6 | sCr: 1.1 | 17% | 3.7 | 2.4+ | NR | NR | 83% | 28% | 22% | 29% | 66% | NR |
Chan et al. 202023 | 74.2 | 42 | 65.4 | NR | 60.9 | 25% | 3.5 | 2.8 | NR | 11% | 75% | 34% | 17% | 12% | 43% | 54% |
Cheng et al. 202124 | 75.7 | 36 | NR | NR | 71.3 | NR | 2.9 | NR | 8% | 25% | 57% | 22% | 2% | 9% | NR | 24% |
Fernandez et al. 202125 | 74.2 | 44 | 79.7 | 29.1 | 76.0 | 16% | 3.5 | 1.6 | 3% | 23% | 79% | 27% | 13% | 17% | 55% | 8% |
Author . | Age (mean) . | Female (%) . | Body weight (kg) . | BMI (kg/m2) . | CrCl (mL/min) . | CKD or CrCl < 50 . | CHA2DS2-VASc . | HAS-BLED . | Bleeding history . | Heart failure . | Hypertension . | Diabetes . | Stroke or TIA . | Vascular disease . | Dyslipidaemia . | Use of APT . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amarenco et al. 20196 | 71.5 | 41 | 83.0 | 28.2 | NR | 9% | 3.4 | NR | NR | 19% | 75% | 20% | 19% | 10% | NR | 18% |
Atarashi et al. 20217 | 71.6 | 32 | 62.7 | NR | NR | 22% | 3.4 | 1.4 | 4% | 27% | 71% | 25% | 24% | 4% | 42% | 9% |
Kim et al. 20218 | 72.5 | 45 | NR | NR | NR | NR | 3.3 | NR | NR | 9% | 63% | 24% | 20% | 11% | NR | NR |
Yagi et al. 20209 | 69.1 | 22 | 67.1 | NR | 75.4 | 16% | 2.2 | 1.5 | NR | 17% | 54% | 16% | 6% | 5% | 31% | 11% |
Cho et al. 202010 | 69.8 | 40 | NR | 25.5 | 72.7 | 2% | 3.3 | 2.4 | NR | 19% | 89% | 47% | 2% | 11% | NR | 9% |
González-Pérez et al. 202211 | 74.9 | 43 | NR | NR | NR | 42% | 3.4 | 1.7 | 27% | 16% | 67% | NR | 13% | 27% | NR | 46% |
Alcusky et al. 202012 | 84 | 69 | NR | NR | NR | 19% | 5 | 3* | NR | 33% | 84% | 35% | 23% | 26% | NR | 23% |
Ikeda et al. 201915 | 69.5 | 31 | 65.3 | 24.8 | 78.8 | 0% | 3.1 | 1.3 | NR | 21% | 74% | 23% | 21% | 3% | NR | 13% |
Yu et al. 202016 | 70.5 | 40 | NR | NR | NR | 8% | 4.6 | NR | NR | 61% | 96% | 32% | 46% | 29% | 92% | 16% |
Arashi et al. 202017 | 71.4 | 14 | 68.6 | 25.4 | 74.3 | 0% | 3.7 | 2.1 | 1% | 30% | 87% | 45% | 13% | 34% | 71% | 36% |
Briasoulis et al. 202018 | NR | 50 | NR | NR | NR | 47% | NR | NR | 25% | 28% | 93% | 49% | 24% | 43% | NR | 26% |
Lee et al. 201919 | 71.2 | 45 | 63.8 | 24.7 | 82.3 | 0% | 3.5 | NR | 0% | 30% | 72% | 22% | 0% | 3% | 42% | NR |
Xu et al. 202220 | 64.2 | 43 | 65.8 | NR | 75.8 | NR | 2.1 | 1.3 | NR | 5% | 81% | 26% | 2% | 7% | NR | NR |
Yao et al. 201721 | 70.6 | 43 | NR | NR | 69.9 | 17% | NR | NR | 11% | 40% | 90% | 42% | 14% | 28% | 82% | 8% |
Ashraf et al. 202122 | 73.8 | 44 | NR | 30.6 | sCr: 1.1 | 17% | 3.7 | 2.4+ | NR | NR | 83% | 28% | 22% | 29% | 66% | NR |
Chan et al. 202023 | 74.2 | 42 | 65.4 | NR | 60.9 | 25% | 3.5 | 2.8 | NR | 11% | 75% | 34% | 17% | 12% | 43% | 54% |
Cheng et al. 202124 | 75.7 | 36 | NR | NR | 71.3 | NR | 2.9 | NR | 8% | 25% | 57% | 22% | 2% | 9% | NR | 24% |
Fernandez et al. 202125 | 74.2 | 44 | 79.7 | 29.1 | 76.0 | 16% | 3.5 | 1.6 | 3% | 23% | 79% | 27% | 13% | 17% | 55% | 8% |
Author . | IS/SEa (rate per 100 PYs) . | Mortalitya (rate per 100 PYs) . | Major bleedinga (rate per 100 PYs) . |
---|---|---|---|
Amarenco et al. 20196 | 1.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 1.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.6 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) |
2.7 (15 mg if CrCl > 50; J-ROCKET AF) | 3.1 (15 mg if CrCl > 50; J-ROCKET AF) | 3.9 (15 mg if CrCl > 50; J-ROCKET AF) | |
2.9 (20 mg if CrCl < 50) | 3.8 (20 mg if CrCl < 50) | 2.9 (20 mg if CrCl < 50) | |
Atarashi et al. 20217 | 1.57 (15 mg if CrCl < 50; ROCKET AF) | 5.09 (15 mg if CrCl < 50; ROCKET AF) | 3.53 (15 mg if CrCl < 50; ROCKET AF) |
0.83 (15 mg if CrCl > 50; J-ROCKET AF) | 0.75 (15 mg if CrCl > 50; J-ROCKET AF) | 1.01 (15 mg if CrCl > 50; J-ROCKET AF) | |
1.46 (10 mg if CrCl < 50; J-ROCKET AF) | 3.69 (10 mg if CrCl < 50; J-RCOKET AF) | 1.80 (10 mg if CrCl < 50; J-ROCKET AF) | |
0.88 (10 mg if CrCl > 50) | 1.67 (10 mg if CrCl > 50) | 1.13 (10 mg if CrCl > 50) | |
Kim et al. 20218 | 1.9 (20 mg if CrCl > 50; ROCKET AF) | 0.9 (20 mg if CrCl > 50; ROCKET AF) | 0.9 (20 mg if CrCl > 50; ROCKET AF) |
2.8 (15 mg if CrCl > 50; J-ROCKET AF) | 1.7 (15 mg if CrCl > 50; J-ROCKET AF) | 2.3 (15 mg if CrCl > 50; J-ROCKET AF) | |
Yagi et al. 20209 | 0.0 (15 mg if CrCl < 50; ROCKET AF) | 0.0 (15 mg if CrCl < 50; ROCKET AF) | 0.0 (15 mg if CrCl < 50; ROCKET AF) |
0.1 (15 mg if CrCl > 50; J-ROCKET AF) | 0.3 (15 mg if CrCl > 50; J-ROCKET AF) | 0.7 (15 mg if CrCl > 50; J-ROCKET AF) | |
0.0 (10 mg if CrCl < 50; J-ROCKET AF) | 0.9 (10 mg if CrCl < 50; J-ROCKET AF) | 1.9 (10 mg if CrCl < 50; J-ROCKET AF) | |
0.0 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | |
Cho et al. 202010 | 2.0 (20 mg if CrCl > 50; ROCKET AF) | 1.7 (20 mg if CrCl > 50; ROCKET AF) | 1.7 (20 mg if CrCl > 50; ROCKET AF) |
2.5 (15 mg if CrCl > 50; J-ROCKET AF) | 1.9 (15 mg if CrCl > 50; J-ROCKET AF) | 2.2 (15 mg if CrCl > 50; J-ROCKET AF) | |
González-Pérez et al. 202211 | 1.7 (20 mg if CrCl < 50; overdosing)d | 19.4 (20 mg if CrCl < 50; overdosing)d | NR |
1.1 (20 mg if CrCl > 50; ROCKET AF)d | 7.3 (20 mg if CrCl > 50; ROCKET AF)d | ||
1.5 (15 mg if CrCl < 50; ROCKET AF)d | 23.1 (15 mg if CrCl < 50; ROCKET AF)d | ||
2.4 (15 mg if CrCl > 50; J-ROCKET AF)d | 32.0 (15 mg if CrCl > 50; J-ROCKET AF)d | ||
Alcusky et al. 202012 | 1.75 (2011–2013)b | 28.18 (2011–2013)b | 6.22 (2011–2013)b |
1.89 (2014–2016)b | 31.17 (2014–2016)b | 6.58 (2014–2016)b | |
Ikeda et al. 201915 | 1.5 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF)c | NR | 1.6 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF)c |
2.2 (10 mg if CrCl > 50)c | 1.3 (10 mg if CrCl > 50)c | ||
Yu et al. 202016 | 5.8 (20 mg if CrCl < 50) | 5.4 (20 mg if CrCl < 50) | 4.8 (20 mg if CrCl < 50) |
4.0 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 3.1 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
4.0 (15 if CrCl > 50; J-ROCKET AF) | 3.2 (15 if CrCl > 50; J-ROCKET AF) | 3.0 (15 if CrCl > 50; J-ROCKET AF) | |
Arashi et al. 202017 | 1.1 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 1.4 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 2.2 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) |
0.7 (10 mg if CrCl > 50) | 1.6 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | |
Briasoulis et al. 202018 | 4.3 (20 mg if CrCl < 50) | NR | 7.9 (20 mg if CrCl < 50) |
2.6 (20 mg if CrCl > 50; ROCKET AF) | 4.3 (20 mg if CrCl > 50; ROCKET AF) | ||
5.7 (15 mg if CrCl < 50; ROCKET AF) | 9.9 (15 mg if CrCl < 50; ROCKET AF) | ||
4.0 (15 mg if CrCl > 50; J-ROCKET AF) | 6.7 (15 mg if CrCl > 50; J-ROCKET AF) | ||
Lee et al. 201919 | 2.2 (20 mg if CrCl > 50; ROCKET AF)c | 3.6 (20 mg if CrCl > 50; ROCKET AF)c | 2.3 (20 mg if CrCl > 50; ROCKET AF)c |
2.6 (15 mg if CrCl > 50; J-ROCKET AF)c | 4.3 (15 mg if CrCl > 50; J-ROCKET AF)c | 2.7 (15 mg if CrCl > 50; J-ROCKET AF)c | |
Xu et al. 202220 | 0.6 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d | 9.2 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d | 2.4 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d |
1.8 (15 if CrCl > 50; J-ROCKET AF)d | 2.9 (15 if CrCl > 50; J-ROCKET AF)d | 0.2 (15 if CrCl > 50; J-ROCKET AF)d | |
Yao et al. 201721 | 2.8 (20 mg if CrCl < 50)c | NR | 11.0 (20 mg if CrCl < 50)c |
1.7 (20 mg if CrCl > 50; ROCKET AF)c | 4.9 (20 mg if CrCl > 50; ROCKET AF)c | ||
1.2 (15 mg if CrCl < 50; ROCKET AF)c | 5.9 (15 mg if CrCl < 50; ROCKET AF)c | ||
1.2 (15 mg if CrCl > 50; J-ROCKET AF)c | 5.4 (15 mg if CrCl > 50; J-ROCKET AF)c | ||
Ashraf et al. 202122 | 18.9 for 5 years (on-label)d,e | 13.0 for 5 years (on-label)d,e | 8.3 for 5 years (on-label)d,e |
22.4 for 5 years (underdosing)d,e | 18.7 for 5 years (underdosing)d,e | 10.2 for 5 years (underdosing)d,e | |
Chan et al. 202023 | 4.3 (20 mg if CrCl < 50) | 4.5 (20 mg if CrCl < 50) | 2.4 (20 mg if CrCl < 50) |
2.0 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 7.8 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 1.3 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
1.4 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 4.8 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 0.7 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | |
2.7 (10 mg if CrCl > 50) | 4.5 (10 mg if CrCl < 50) | 0.5 (10 mg if CrCl < 50) | |
Cheng et al. 202124 | 0.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF or | NR | NR |
15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | |||
2.8 (10 mg if CrCl > 50) | |||
Fernandez et al. 202125 | 1.1 (20 mg if CrCl < 50) | 3.4 (20 mg if CrCl < 50) | 2.3 (20 mg if CrCl < 50) |
0.5 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.3 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 0.8 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
0.4 (15 if CrCl > 50; J-ROCKET AF) | 5.8 (15 if CrCl > 50; J-ROCKET AF) | 1.3 (15 if CrCl > 50; J-ROCKET AF) |
Author . | IS/SEa (rate per 100 PYs) . | Mortalitya (rate per 100 PYs) . | Major bleedinga (rate per 100 PYs) . |
---|---|---|---|
Amarenco et al. 20196 | 1.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 1.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.6 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) |
2.7 (15 mg if CrCl > 50; J-ROCKET AF) | 3.1 (15 mg if CrCl > 50; J-ROCKET AF) | 3.9 (15 mg if CrCl > 50; J-ROCKET AF) | |
2.9 (20 mg if CrCl < 50) | 3.8 (20 mg if CrCl < 50) | 2.9 (20 mg if CrCl < 50) | |
Atarashi et al. 20217 | 1.57 (15 mg if CrCl < 50; ROCKET AF) | 5.09 (15 mg if CrCl < 50; ROCKET AF) | 3.53 (15 mg if CrCl < 50; ROCKET AF) |
0.83 (15 mg if CrCl > 50; J-ROCKET AF) | 0.75 (15 mg if CrCl > 50; J-ROCKET AF) | 1.01 (15 mg if CrCl > 50; J-ROCKET AF) | |
1.46 (10 mg if CrCl < 50; J-ROCKET AF) | 3.69 (10 mg if CrCl < 50; J-RCOKET AF) | 1.80 (10 mg if CrCl < 50; J-ROCKET AF) | |
0.88 (10 mg if CrCl > 50) | 1.67 (10 mg if CrCl > 50) | 1.13 (10 mg if CrCl > 50) | |
Kim et al. 20218 | 1.9 (20 mg if CrCl > 50; ROCKET AF) | 0.9 (20 mg if CrCl > 50; ROCKET AF) | 0.9 (20 mg if CrCl > 50; ROCKET AF) |
2.8 (15 mg if CrCl > 50; J-ROCKET AF) | 1.7 (15 mg if CrCl > 50; J-ROCKET AF) | 2.3 (15 mg if CrCl > 50; J-ROCKET AF) | |
Yagi et al. 20209 | 0.0 (15 mg if CrCl < 50; ROCKET AF) | 0.0 (15 mg if CrCl < 50; ROCKET AF) | 0.0 (15 mg if CrCl < 50; ROCKET AF) |
0.1 (15 mg if CrCl > 50; J-ROCKET AF) | 0.3 (15 mg if CrCl > 50; J-ROCKET AF) | 0.7 (15 mg if CrCl > 50; J-ROCKET AF) | |
0.0 (10 mg if CrCl < 50; J-ROCKET AF) | 0.9 (10 mg if CrCl < 50; J-ROCKET AF) | 1.9 (10 mg if CrCl < 50; J-ROCKET AF) | |
0.0 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | |
Cho et al. 202010 | 2.0 (20 mg if CrCl > 50; ROCKET AF) | 1.7 (20 mg if CrCl > 50; ROCKET AF) | 1.7 (20 mg if CrCl > 50; ROCKET AF) |
2.5 (15 mg if CrCl > 50; J-ROCKET AF) | 1.9 (15 mg if CrCl > 50; J-ROCKET AF) | 2.2 (15 mg if CrCl > 50; J-ROCKET AF) | |
González-Pérez et al. 202211 | 1.7 (20 mg if CrCl < 50; overdosing)d | 19.4 (20 mg if CrCl < 50; overdosing)d | NR |
1.1 (20 mg if CrCl > 50; ROCKET AF)d | 7.3 (20 mg if CrCl > 50; ROCKET AF)d | ||
1.5 (15 mg if CrCl < 50; ROCKET AF)d | 23.1 (15 mg if CrCl < 50; ROCKET AF)d | ||
2.4 (15 mg if CrCl > 50; J-ROCKET AF)d | 32.0 (15 mg if CrCl > 50; J-ROCKET AF)d | ||
Alcusky et al. 202012 | 1.75 (2011–2013)b | 28.18 (2011–2013)b | 6.22 (2011–2013)b |
1.89 (2014–2016)b | 31.17 (2014–2016)b | 6.58 (2014–2016)b | |
Ikeda et al. 201915 | 1.5 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF)c | NR | 1.6 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF)c |
2.2 (10 mg if CrCl > 50)c | 1.3 (10 mg if CrCl > 50)c | ||
Yu et al. 202016 | 5.8 (20 mg if CrCl < 50) | 5.4 (20 mg if CrCl < 50) | 4.8 (20 mg if CrCl < 50) |
4.0 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 3.1 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
4.0 (15 if CrCl > 50; J-ROCKET AF) | 3.2 (15 if CrCl > 50; J-ROCKET AF) | 3.0 (15 if CrCl > 50; J-ROCKET AF) | |
Arashi et al. 202017 | 1.1 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 1.4 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 2.2 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) |
0.7 (10 mg if CrCl > 50) | 1.6 (10 mg if CrCl > 50) | 0.8 (10 mg if CrCl > 50) | |
Briasoulis et al. 202018 | 4.3 (20 mg if CrCl < 50) | NR | 7.9 (20 mg if CrCl < 50) |
2.6 (20 mg if CrCl > 50; ROCKET AF) | 4.3 (20 mg if CrCl > 50; ROCKET AF) | ||
5.7 (15 mg if CrCl < 50; ROCKET AF) | 9.9 (15 mg if CrCl < 50; ROCKET AF) | ||
4.0 (15 mg if CrCl > 50; J-ROCKET AF) | 6.7 (15 mg if CrCl > 50; J-ROCKET AF) | ||
Lee et al. 201919 | 2.2 (20 mg if CrCl > 50; ROCKET AF)c | 3.6 (20 mg if CrCl > 50; ROCKET AF)c | 2.3 (20 mg if CrCl > 50; ROCKET AF)c |
2.6 (15 mg if CrCl > 50; J-ROCKET AF)c | 4.3 (15 mg if CrCl > 50; J-ROCKET AF)c | 2.7 (15 mg if CrCl > 50; J-ROCKET AF)c | |
Xu et al. 202220 | 0.6 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d | 9.2 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d | 2.4 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF)d |
1.8 (15 if CrCl > 50; J-ROCKET AF)d | 2.9 (15 if CrCl > 50; J-ROCKET AF)d | 0.2 (15 if CrCl > 50; J-ROCKET AF)d | |
Yao et al. 201721 | 2.8 (20 mg if CrCl < 50)c | NR | 11.0 (20 mg if CrCl < 50)c |
1.7 (20 mg if CrCl > 50; ROCKET AF)c | 4.9 (20 mg if CrCl > 50; ROCKET AF)c | ||
1.2 (15 mg if CrCl < 50; ROCKET AF)c | 5.9 (15 mg if CrCl < 50; ROCKET AF)c | ||
1.2 (15 mg if CrCl > 50; J-ROCKET AF)c | 5.4 (15 mg if CrCl > 50; J-ROCKET AF)c | ||
Ashraf et al. 202122 | 18.9 for 5 years (on-label)d,e | 13.0 for 5 years (on-label)d,e | 8.3 for 5 years (on-label)d,e |
22.4 for 5 years (underdosing)d,e | 18.7 for 5 years (underdosing)d,e | 10.2 for 5 years (underdosing)d,e | |
Chan et al. 202023 | 4.3 (20 mg if CrCl < 50) | 4.5 (20 mg if CrCl < 50) | 2.4 (20 mg if CrCl < 50) |
2.0 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 7.8 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 1.3 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
1.4 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 4.8 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | 0.7 (15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | |
2.7 (10 mg if CrCl > 50) | 4.5 (10 mg if CrCl < 50) | 0.5 (10 mg if CrCl < 50) | |
Cheng et al. 202124 | 0.9 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF or | NR | NR |
15 or 10 mg if CrCl > 50 or <50; J-ROCKET AF) | |||
2.8 (10 mg if CrCl > 50) | |||
Fernandez et al. 202125 | 1.1 (20 mg if CrCl < 50) | 3.4 (20 mg if CrCl < 50) | 2.3 (20 mg if CrCl < 50) |
0.5 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 2.3 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | 0.8 (20 or 15 mg if CrCl > 50 or <50; ROCKET AF) | |
0.4 (15 if CrCl > 50; J-ROCKET AF) | 5.8 (15 if CrCl > 50; J-ROCKET AF) | 1.3 (15 if CrCl > 50; J-ROCKET AF) |
IS/SE, ischemic stroke/systemic embolism; PY, patient-year; TIA, transient ischemic attack.
aCrude annual incidence rate before adjustment.
bNot reporting annual incidence rate for patients treated with on-labelling, underdosing, and overdosing rivaroxaban individually.
cOnly reporting annual incidence rate after adjustment.
dOnly reporting overall incidence rate without annual adjustment.
eNot reporting annual incidence rate for rivaroxaban, dabigatran, or apixaban individually.
*ATRIA bleeding score.
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