Demographic and baseline characteristics, cardiovascular history, and medication history of patients with early AF (onset ≤12 months)
| Characteristic . | Dronedarone (n = 924) . | Placebo (n = 886) . |
|---|---|---|
| Demographic and baseline characteristics/cardiovascular history | ||
| Age, mean (SD), years | 73 (8.2) | 73 (8.8) |
| Male | 421 (45.6) | 453 (51.1) |
| Race | ||
| Caucasian | 790 (85.5) | 754 (85.1) |
| Asian | 72 (7.8) | 61 (6.9) |
| Black | 13 (1.4) | 21 (2.4) |
| Other | 49 (5.3) | 50 (5.6) |
| BMI ≥30 kg/m2 | 291 (31.5) | 278 (31.4) |
| Hypertension | 815 (88.2) | 760 (85.8) |
| Non-insulin-dependent diabetes mellitus | 180 (19.5) | 182 (20.5) |
| Insulin-dependent diabetes mellitus | 30 (3.2) | 35 (4.0) |
| eGFR MDRD, mean (SD), mL/min | 66.6 (18.4) | 66.3 (19.2) |
| Time since first AF, median (Q1, Q3), days | 50.0 (14.5, 114.5) | 50.5 (14.0, 122.0) |
| LVEF, mean (SD), % | 58.2 (11.0) | 57.1 (12.0) |
| LVEF, % | ||
| <35% | 29 (3.2) | 44 (5.1) |
| ≤40% (i.e. HFrEF)a | 76 (8.3) | 106 (12.2) |
| <45% | 97 (10.6) | 129 (14.9) |
| <50% | 148 (16.2) | 173 (20.0) |
| Left HF, NYHA class | ||
| Class I | 81 (8.8) | 60 (6.8) |
| Class II | 128 (13.9) | 165 (18.6) |
| Class III | 27 (2.9) | 29 (3.3) |
| No HF | 688 (74.5) | 632 (71.3) |
| LAD >40 mm | 593 (65.0) | 569 (65.9) |
| CHA2DS2VASc score, mean (SD) | 3.8 (1.4) | 3.8 (1.4) |
| Structural heart disease | 500 (54.4) | 533 (60.7) |
| Coronary heart disease | 260 (28.1) | 276 (31.2) |
| Non-rheumatic valvular heart disease | 118 (12.8) | 139 (15.7) |
| Pacemaker | 63 (6.8) | 56 (6.3) |
| Ablation for AF | 10 (1.1) | 18 (2.0) |
| Medication use | ||
| ACE inhibitors or angiotensin II receptor antagonist | 638 (69.0) | 596 (67.3) |
| Beta-blockers (except sotalol) | 638 (69.0) | 601 (67.8) |
| Calcium antagonists with HR-lowering effects | 142 (15.4) | 107 (12.1) |
| Oral anticoagulants | 537 (58.1) | 522 (58.9) |
| Diuretics (excluding spironolactone) | 473 (51.2) | 469 (52.9) |
| Low-dose aspirin (≤365 mg) | 441 (47.7) | 386 (43.6) |
| Statins (CYP3A4 metabolized) | 299 (32.4) | 305 (34.4) |
| Digitalis | 121 (13.1) | 127 (14.3) |
| Characteristic . | Dronedarone (n = 924) . | Placebo (n = 886) . |
|---|---|---|
| Demographic and baseline characteristics/cardiovascular history | ||
| Age, mean (SD), years | 73 (8.2) | 73 (8.8) |
| Male | 421 (45.6) | 453 (51.1) |
| Race | ||
| Caucasian | 790 (85.5) | 754 (85.1) |
| Asian | 72 (7.8) | 61 (6.9) |
| Black | 13 (1.4) | 21 (2.4) |
| Other | 49 (5.3) | 50 (5.6) |
| BMI ≥30 kg/m2 | 291 (31.5) | 278 (31.4) |
| Hypertension | 815 (88.2) | 760 (85.8) |
| Non-insulin-dependent diabetes mellitus | 180 (19.5) | 182 (20.5) |
| Insulin-dependent diabetes mellitus | 30 (3.2) | 35 (4.0) |
| eGFR MDRD, mean (SD), mL/min | 66.6 (18.4) | 66.3 (19.2) |
| Time since first AF, median (Q1, Q3), days | 50.0 (14.5, 114.5) | 50.5 (14.0, 122.0) |
| LVEF, mean (SD), % | 58.2 (11.0) | 57.1 (12.0) |
| LVEF, % | ||
| <35% | 29 (3.2) | 44 (5.1) |
| ≤40% (i.e. HFrEF)a | 76 (8.3) | 106 (12.2) |
| <45% | 97 (10.6) | 129 (14.9) |
| <50% | 148 (16.2) | 173 (20.0) |
| Left HF, NYHA class | ||
| Class I | 81 (8.8) | 60 (6.8) |
| Class II | 128 (13.9) | 165 (18.6) |
| Class III | 27 (2.9) | 29 (3.3) |
| No HF | 688 (74.5) | 632 (71.3) |
| LAD >40 mm | 593 (65.0) | 569 (65.9) |
| CHA2DS2VASc score, mean (SD) | 3.8 (1.4) | 3.8 (1.4) |
| Structural heart disease | 500 (54.4) | 533 (60.7) |
| Coronary heart disease | 260 (28.1) | 276 (31.2) |
| Non-rheumatic valvular heart disease | 118 (12.8) | 139 (15.7) |
| Pacemaker | 63 (6.8) | 56 (6.3) |
| Ablation for AF | 10 (1.1) | 18 (2.0) |
| Medication use | ||
| ACE inhibitors or angiotensin II receptor antagonist | 638 (69.0) | 596 (67.3) |
| Beta-blockers (except sotalol) | 638 (69.0) | 601 (67.8) |
| Calcium antagonists with HR-lowering effects | 142 (15.4) | 107 (12.1) |
| Oral anticoagulants | 537 (58.1) | 522 (58.9) |
| Diuretics (excluding spironolactone) | 473 (51.2) | 469 (52.9) |
| Low-dose aspirin (≤365 mg) | 441 (47.7) | 386 (43.6) |
| Statins (CYP3A4 metabolized) | 299 (32.4) | 305 (34.4) |
| Digitalis | 121 (13.1) | 127 (14.3) |
Data are n (%) unless otherwise stated and include the total number of patients in dronedarone and placebo groups. Early AF defined as first known AF onset within ≤12 months.
ACC, American College of Cardiology; ACE, angiotensin-converting enzyme; AF, atrial fibrillation/atrial flutter; AHA, American Heart Association; BMI, body mass index; CHA2DS2VASc, congestive heart failure, high blood pressure, age >75 years, diabetes, previous stroke or clot, vascular disease, age 65–74 years, sex; CYP3A4, cytochrome P450 3A4; eGFR, estimated glomerular filtration rate; ESC, European Society of Cardiology; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; HFSA, Heart Failure Society of America; HR, heart rate; LAD, left atrium diameter; LVEF, left ventricular ejection fraction; MDRD, modification of diet in renal disease; NYHA, New York Heart Association; SD, standard deviation.
aDefined per ACC/AHA/HFSA 2022 and ESC 2021 guidelines.13
Demographic and baseline characteristics, cardiovascular history, and medication history of patients with early AF (onset ≤12 months)
| Characteristic . | Dronedarone (n = 924) . | Placebo (n = 886) . |
|---|---|---|
| Demographic and baseline characteristics/cardiovascular history | ||
| Age, mean (SD), years | 73 (8.2) | 73 (8.8) |
| Male | 421 (45.6) | 453 (51.1) |
| Race | ||
| Caucasian | 790 (85.5) | 754 (85.1) |
| Asian | 72 (7.8) | 61 (6.9) |
| Black | 13 (1.4) | 21 (2.4) |
| Other | 49 (5.3) | 50 (5.6) |
| BMI ≥30 kg/m2 | 291 (31.5) | 278 (31.4) |
| Hypertension | 815 (88.2) | 760 (85.8) |
| Non-insulin-dependent diabetes mellitus | 180 (19.5) | 182 (20.5) |
| Insulin-dependent diabetes mellitus | 30 (3.2) | 35 (4.0) |
| eGFR MDRD, mean (SD), mL/min | 66.6 (18.4) | 66.3 (19.2) |
| Time since first AF, median (Q1, Q3), days | 50.0 (14.5, 114.5) | 50.5 (14.0, 122.0) |
| LVEF, mean (SD), % | 58.2 (11.0) | 57.1 (12.0) |
| LVEF, % | ||
| <35% | 29 (3.2) | 44 (5.1) |
| ≤40% (i.e. HFrEF)a | 76 (8.3) | 106 (12.2) |
| <45% | 97 (10.6) | 129 (14.9) |
| <50% | 148 (16.2) | 173 (20.0) |
| Left HF, NYHA class | ||
| Class I | 81 (8.8) | 60 (6.8) |
| Class II | 128 (13.9) | 165 (18.6) |
| Class III | 27 (2.9) | 29 (3.3) |
| No HF | 688 (74.5) | 632 (71.3) |
| LAD >40 mm | 593 (65.0) | 569 (65.9) |
| CHA2DS2VASc score, mean (SD) | 3.8 (1.4) | 3.8 (1.4) |
| Structural heart disease | 500 (54.4) | 533 (60.7) |
| Coronary heart disease | 260 (28.1) | 276 (31.2) |
| Non-rheumatic valvular heart disease | 118 (12.8) | 139 (15.7) |
| Pacemaker | 63 (6.8) | 56 (6.3) |
| Ablation for AF | 10 (1.1) | 18 (2.0) |
| Medication use | ||
| ACE inhibitors or angiotensin II receptor antagonist | 638 (69.0) | 596 (67.3) |
| Beta-blockers (except sotalol) | 638 (69.0) | 601 (67.8) |
| Calcium antagonists with HR-lowering effects | 142 (15.4) | 107 (12.1) |
| Oral anticoagulants | 537 (58.1) | 522 (58.9) |
| Diuretics (excluding spironolactone) | 473 (51.2) | 469 (52.9) |
| Low-dose aspirin (≤365 mg) | 441 (47.7) | 386 (43.6) |
| Statins (CYP3A4 metabolized) | 299 (32.4) | 305 (34.4) |
| Digitalis | 121 (13.1) | 127 (14.3) |
| Characteristic . | Dronedarone (n = 924) . | Placebo (n = 886) . |
|---|---|---|
| Demographic and baseline characteristics/cardiovascular history | ||
| Age, mean (SD), years | 73 (8.2) | 73 (8.8) |
| Male | 421 (45.6) | 453 (51.1) |
| Race | ||
| Caucasian | 790 (85.5) | 754 (85.1) |
| Asian | 72 (7.8) | 61 (6.9) |
| Black | 13 (1.4) | 21 (2.4) |
| Other | 49 (5.3) | 50 (5.6) |
| BMI ≥30 kg/m2 | 291 (31.5) | 278 (31.4) |
| Hypertension | 815 (88.2) | 760 (85.8) |
| Non-insulin-dependent diabetes mellitus | 180 (19.5) | 182 (20.5) |
| Insulin-dependent diabetes mellitus | 30 (3.2) | 35 (4.0) |
| eGFR MDRD, mean (SD), mL/min | 66.6 (18.4) | 66.3 (19.2) |
| Time since first AF, median (Q1, Q3), days | 50.0 (14.5, 114.5) | 50.5 (14.0, 122.0) |
| LVEF, mean (SD), % | 58.2 (11.0) | 57.1 (12.0) |
| LVEF, % | ||
| <35% | 29 (3.2) | 44 (5.1) |
| ≤40% (i.e. HFrEF)a | 76 (8.3) | 106 (12.2) |
| <45% | 97 (10.6) | 129 (14.9) |
| <50% | 148 (16.2) | 173 (20.0) |
| Left HF, NYHA class | ||
| Class I | 81 (8.8) | 60 (6.8) |
| Class II | 128 (13.9) | 165 (18.6) |
| Class III | 27 (2.9) | 29 (3.3) |
| No HF | 688 (74.5) | 632 (71.3) |
| LAD >40 mm | 593 (65.0) | 569 (65.9) |
| CHA2DS2VASc score, mean (SD) | 3.8 (1.4) | 3.8 (1.4) |
| Structural heart disease | 500 (54.4) | 533 (60.7) |
| Coronary heart disease | 260 (28.1) | 276 (31.2) |
| Non-rheumatic valvular heart disease | 118 (12.8) | 139 (15.7) |
| Pacemaker | 63 (6.8) | 56 (6.3) |
| Ablation for AF | 10 (1.1) | 18 (2.0) |
| Medication use | ||
| ACE inhibitors or angiotensin II receptor antagonist | 638 (69.0) | 596 (67.3) |
| Beta-blockers (except sotalol) | 638 (69.0) | 601 (67.8) |
| Calcium antagonists with HR-lowering effects | 142 (15.4) | 107 (12.1) |
| Oral anticoagulants | 537 (58.1) | 522 (58.9) |
| Diuretics (excluding spironolactone) | 473 (51.2) | 469 (52.9) |
| Low-dose aspirin (≤365 mg) | 441 (47.7) | 386 (43.6) |
| Statins (CYP3A4 metabolized) | 299 (32.4) | 305 (34.4) |
| Digitalis | 121 (13.1) | 127 (14.3) |
Data are n (%) unless otherwise stated and include the total number of patients in dronedarone and placebo groups. Early AF defined as first known AF onset within ≤12 months.
ACC, American College of Cardiology; ACE, angiotensin-converting enzyme; AF, atrial fibrillation/atrial flutter; AHA, American Heart Association; BMI, body mass index; CHA2DS2VASc, congestive heart failure, high blood pressure, age >75 years, diabetes, previous stroke or clot, vascular disease, age 65–74 years, sex; CYP3A4, cytochrome P450 3A4; eGFR, estimated glomerular filtration rate; ESC, European Society of Cardiology; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; HFSA, Heart Failure Society of America; HR, heart rate; LAD, left atrium diameter; LVEF, left ventricular ejection fraction; MDRD, modification of diet in renal disease; NYHA, New York Heart Association; SD, standard deviation.
aDefined per ACC/AHA/HFSA 2022 and ESC 2021 guidelines.13
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