Table 1.
Characteristics of the Study Population at Randomization or 1 Year Before Death
| Characteristic | Mode of Death | P Value* | |||
|---|---|---|---|---|---|
| Sudden Cardiac Death (n = 72) | Heart Failure (n = 80) | Other Cardiovascular (n = 34) | Noncardiovascular (n = 45) | ||
| Age, mean (SD), years† | 61 (13) | 66 (12.9) | 66 (12) | 66 (12) | .06 |
| Male | 60 (83%) | 62 (78%) | 27 (79%) | 36 (80%) | .84 |
| Race | .11 | ||||
| Black or African American | 29 (41%) | 24 (30%) | 10 (30%) | 16 (36%) | |
| White | 37 (53%) | 48 (60%) | 23 (70%) | 28 (64%) | |
| Other or missing | 4 (5.7%) | 8 (10%) | 0 | 0 | |
| NYHA class† | .005 | ||||
| I | 4 (6%) | 2 (3%) | 1 (3%) | 1 (2%) | |
| II | 28 (39%) | 12 (15%) | 10 (29%) | 13 (29%) | |
| III | 34 (47%) | 36 (45%) | 15 (44%) | 17 (38%) | |
| IV | 6 (8%) | 30 (38%) | 8 (24%) | 14 (31%) | |
| Ischemic etiology | 39 (54%) | 52 (65%) | 17 (50%) | 30 (66.67%) | .25 |
| Body mass index, mean (SD) | 31.6 (7.5) | 29.4 (7.4) | 30.3 (5.8) | 29.6 (5.3) | .27 |
| Systolic blood pressure, mean (SD), mm Hg | 113.4 (17.6) | 107.6 (17.9) | 111.2 (20.9) | 119.3 (15.7) | .001 |
| Diastolic blood pressure, mean (SD), mm Hg | 68.0 (11.6) | 67.1 (10.5) | 67.9 (10.7) | 69.9 (9.4) | .31 |
| Comorbid conditions | |||||
| Cancer in past 5 years | 2 (2.8%) | 4 (5%) | 2 (6%) | 2 (4.4%) | .87 |
| Chronic obstructive pulmonary disease | 14 (20%) | 9 (11%) | 0 (0%) | 10 (22%) | .02 |
| Diabetes mellitus | 25 (35%) | 26 (33%) | 17 (50%) | 17 (38%) | .34 |
| History of depression | 10 (14%) | 13 (16%) | 5 (15%) | 8 (18%) | .95 |
| History of stroke | 6 (8%) | 10 (13%) | 3 (9%) | 6 (13%) | .77 |
| Hyperlipidemia | 48 (67%) | 52 (65%) | 26 (76%) | 30 (67%) | .68 |
| Hypertension | 41 (58%) | 50 (63%) | 19 (56%) | 32 (71%) | .45 |
| Peripheral vascular disease | 9 (13%) | 7 (9%) | 4 (12%) | 4 (9%) | .87 |
| Hospitalized within 6 months of enrollment | 21 (29%) | 27 (34%) | 13 (38%) | 22 (49%) | .18 |
| Cardiac devices | |||||
| Implantable cardioverter-defibrillator | 16 (22%) | 45 (56%) | 18 (53%) | 22 (49%) | < .001 |
| Biventricular pacemaker | 6 (8%) | 19 (24%) | 10 (29%) | 8 (18%) | .03 |
| Pacemaker | 11 (15%) | 23 (29%) | 6 (18%) | 10 (22%) | .22 |
| Blood urea nitrogen, mean (SD), mg/dL | 25.5 (14.8) | 36.0 (21.8) | 30.0 (15.2) | 30.5 (18.7) | .008 |
| Creatinine, mean (SD), mg/dL | 1.4 (0.4) | 1.6 (0.6) | 1.8 (1.5) | 1.7 (1.4) | .01 |
| Sodium, mean (SD), mEq/L | 139.5 (3.0) | 138.0 (3.9) | 139.5 (3.3) | 139.7 (3.7) | .05 |
| Left ventricular ejection fraction, mean (SD), % | 24.3 (8.1) | 21.4 (6.6) | 22.7 (7.0) | 26.7 (7.8) | .001 |
| Exercise duration on cardiopulmonary exercise stress test, mean (SD), minutes | 8.5 (3.7) | 7.2 (2.8) | 7.7 (2.7) | 8.2 (3.3) | .19 |
| Peak VO2, mean (SD), ml/kg/min | 13.2 (3.9) | 11.6 (3.5) | 12.8 (3.1) | 12.6 (3.5) | .07 |
| KCCQ overall summary score, mean (SD)† | 64.7 (20.8) | 55.8 (25.0) | 65.6 (21.3) | 61.4 (23.4) | .12 |
| Medications† | |||||
| ACE inhibitor | 45 (63%) | 34 (43%) | 16 (47%) | 23 (51%) | .10 |
| Angiotensin receptor blocker | 13 (18%) | 11 (14%) | 7 (21%) | 6 (13%) | .73 |
| Antiarrhythmic agent | 22 (31%) | 33 (41%) | 10 (29%) | 14 (31%) | .43 |
| Aspirin | 42 (58%) | 41 (51%) | 20 (59%) | 26 (58%) | .79 |
| β-Blocker | 66 (92%) | 55 (69%) | 29 (85%) | 35 (78%) | .004 |
| Lipid-lowering agent | 45 (63%) | 45 (56%) | 22 (65%) | 21 (47%) | .30 |
| Loop diuretic | 51 (71%) | 69 (86%) | 26 (76%) | 37 (82%) | .12 |
| Potassium-sparing diuretic | 29 (40%) | 34 (43%) | 9 (26%) | 11 (24%) | .11 |
Abbreviation: KCCQ, Kansas City Cardiomyopathy Questionnaire.
*
P values from χ2 tests for categorical variables and Kruskal-Wallis tests for continuous variables.
†
Measured at 1 year before death.