Table 1.
Characteristics of the Participants.*
| Characteristic | Device Group (N = 1524) |
Control Group (N=778) |
|---|---|---|
| Age — yr | 60.9±12.6 | 61.4±12.3 |
| Male sex — no./total no. (%) | 1108/1521 (72.8) | 577/772 (74.7) |
| Body-mass index† | 28.4±5.5 | 28.4±5.5 |
| Race or ethnic group — no./total no. (%)‡ | ||
| White | 1279/1491 (85.8) | 636/751 (84.7) |
| Black | 143/1491 (9.6) | 75/751 (10.0) |
| Asian | 23/1491 (1.5) | 14/751 (1.9) |
| Native American or Alaskan | 25/1491 (1.7) | 12/751 (1.6) |
| Pacific Islander or Hawaiian | 1/1491 (0.1) | 0/751 |
| Multiple | 20/1491 (1.3) | 14/751 (1.9) |
| Hispanic | 85/1521 (5.6) | 34/772 (4.4) |
| Baseline condition before index hospitalization — no./total no. (%) | ||
| Current smoking | 561/1520 (36.9) | 273/770 (35.5) |
| Diabetes mellitus | 497/1521 (32.7) | 246/776 (31.7) |
| Hypertension | 994/1521 (65.4) | 501/776 (64.6) |
| Previous myocardial infarction | 380/1518 (25.0) | 193/775 (24.9) |
| Previous CABG | 133/1521 (8.7) | 70/776 (9.0) |
| Previous PCI | 374/1520 (24.6) | 202/776 (26.0) |
| Previous congestive heart failure | 247/1518 (16.3) | 146/774 (18.9) |
| NYHA functional class | ||
| I | 691/1520 (45.5) | 326/775 (42.1) |
| II | 529/1520 (34.8) | 286/775 (36.9) |
| III | 211/1520 (13.9) | 116/775 (15.0) |
| IV | 46/1520 (3.0) | 18/775 (2.3) |
| Index hospitalization for myocardial infarction | ||
| Left ventricular ejection fraction§ | ||
| Mean | 28.2±6.1 | 28.2±5.8 |
| Distribution — no./total no. (%) | ||
| <25% | 301/1519 (19.8) | 148/777 (19.0) |
| 25 to 35% | 1217/1519 (80.1) | 627/777 (80.7) |
| >35% | 1/1519 (0.1) | 2/777 (0.3) |
| PCI during index hospitalization — no./total no. (%) | 1275/1513 (84.3) | 650/773 (84.1) |
| Thrombolytic agent during index hospitalization — no./total no. (%) | 118/1513 (7.8) | 71/773 (9.2) |
| CABG during index hospitalization — no. (%) | 14 (0.9) | 12 (1.5) |
| Cardiac arrest or ventricular fibrillation — no./total no. (%) | 169/1513 (11.2) | 70/773 (9.1) |
| Pulmonary edema leading to intubation — no./total no. (%) | 162/1513 (10.7) | 88/773 (11.4) |
| Intraaortic balloon pump — no./total no. (%) | 173/1513 (11.4) | 93/773 (12.0) |
| Cardiogenic shock — no./total no. (%) | 136/1513 (9.0) | 79/773 (10.2) |
| Atrial fibrillation during hospitalization — no./total no. (%) | 156/1513 (10.3) | 91/773 (11.8) |
| Median maximum creatinine level (IQR) — mg/dl¶ | 1.1 (0.9–1.3) | 1.1 (0.9–1.4) |
| Median no. of days from admission to randomization (IQR) | 5.0 (3.0–8.0) | 5.0 (3.0–7.0) |
*
Plus–minus values are means ±SD. There were no significant differences (P<0.05) between the trial groups. Percentages may not total 100 because of rounding. CABG denotes coronary-artery bypass grafting, IQR interquartile range, NYHA New York Heart Association, and PCI percutaneous coronary intervention.
†
The body-mass index is the weight in kilograms divided by the square of the height in meters.
‡
Race and ethnic group were reported by the participant.
§
An ejection fraction of 35% or less was an inclusion criterion for the study. An ejection fraction of more than 35% represents a protocol violation.
¶
To convert values for creatinine to micromoles per liter, multiply by 88.4.