Table 1. Baseline Characteristics in the Primary Analysis Population.
| Characteristic | No. (%) | |
|---|---|---|
| Placebo (n = 296) | Aspirin (n = 293) | |
| Demographics | ||
| Age, y | ||
| Mean (SD) | 58 (13) | 57 (14) |
| Median (range) | 60 (20-79) | 59 (18-80) |
| Women | 72 (24) | 61 (21) |
| Men | 224 (76) | 232 (79) |
| Race and ethnicitya | ||
| Asian | 13 (4.4) | 9 (3.1) |
| Black | 93 (31.4) | 84 (28.7) |
| Native Hawaiian or Pacific Islander | 2 (0.7) | 3 (1.0) |
| White | 179 (60.5) | 181 (61.8) |
| Otherb | 3 (1.0) | 3 (1.0) |
| Did not provide or unspecified | 6 (2.0) | 13 (4.4) |
| Enrolled in North Americac | 251 (85) | 248 (85) |
| Medical history | ||
| Ischemic etiology of heart failure | 106 (35.8) | 101 (34.5) |
| History of atrial fibrillation | 137 (46.3) | 122 (41.6) |
| History of stroke | 44 (14.9) | 35 (11.9) |
| History of bleeding | 17 (5.7) | 12 (4.1) |
| History of diabetes | 134 (45.3) | 106 (36.2) |
| History of percutaneous coronary interventiond | 78 (26.4) | 72 (24.6) |
| Prior cardiac surgical procedures | ||
| Coronary artery bypass | 35 (11.8) | 32 (10.9) |
| Valve replacement or repair | 25 (8.4) | 25 (8.5) |
| Hemodynamics e | ||
| Left ventricular ejection fraction, % | 16 (12-21) [n = 252] | 17 (12-20) [n = 252] |
| Arterial blood pressure, mm Hg | ||
| Systolic | 106 (96-118) [n = 294] | 106 (95-117) [n = 291] |
| Diastolic | 69 (60-75) [n = 294] | 68 (61-75) [n = 291] |
| Mean arterial pressure, mm Hgf | 81 (74-88) [n = 281] | 80 (74-89) [n = 282] |
| Right atrial pressure, mm Hg | 10.0 (6.0-14.0) [n = 203] | 11.0 (6.0-15.0) [n = 200] |
| Pulmonary vascular resistance, Wood units | 3.03 (2.00-4.10) [n = 201] | 2.90 (1.90-4.40) [n = 187] |
| Cardiac index, L/min/m2 | 1.80 (1.52-2.28) [n = 231] | 1.82 (1.58-2.30) [n = 221] |
| Pulmonary-capillary wedge pressure, mm Hg | 25 (17-30) [n = 225] | 25 (19-30) [n = 216] |
| Laboratory values e , g | ||
| Hemoglobin, g/dL | 11.6 (10.1-13.1) | 11.7 (10.3-13.1) |
| Hematocrit, % | 36 (31-40) | 36 (32-40) |
| Platelets, ×103/μL | 200 (158-255) | 198 (150-253) |
| Estimated glomerular filtration rate, mL/min/1.73 m2 | 60 (43-76) [n = 295] | 60 (44-75) [n = 291] |
| Total bilirubin, mg/dL | 0.90 (0.60-1.40) | 0.90 (0.60-1.40) [n = 290] |
| Baseline antithrombotic medicationh | ||
| Aspirin | 40 (13.5) | 47 (16.0) |
| VKAi | 7 (2.4) | 8 (2.7) |
| Direct oral anticoagulants (apixaban or rivaroxaban) | 11 (3.7) | 11 (3.8) |
| Intended goal of pump support | ||
| Bridge to transplant | 56 (18.9) | 58 (19.8) |
| Bridge to candidacy for transplant | 46 (15.5) | 50 (17.1) |
| Destination therapyj | 180 (60.8) | 174(59.4) |
| Bridge to recovery | 14 (4.7) | 11 (3.8) |
| INTERMACS profile (disease severity)k | ||
| 1 (most severe illness) | 12 (4.1) | 18 (6.1) |
| 2 | 76 (25.7) | 75 (25.6) |
| 3 | 133 (44.9) | 133 (45.4) |
| 4 | 66 (22.3) | 54 (18.4) |
| 5 | 6 (2.0) | 8 (2.7) |
| 6 | 3 (1.0) | 5 (1.7) |
| 7 (least severe illness) | 0 | 0 |
| LVAD surgical details | ||
| Procedures concurrent with LVAD implant | ||
| Patent foramen ovale closure | 15 (5.1) | 13 (4.4) |
| Left atrial appendage exclusion | 53 (17.9) | 44 (15.0) |
| Valve replacement or repair | 74 (25.0) | 82 (28.0) |
Race or ethnicity were self-reported.
Other racial and ethnic groups included Hispanic (n = 2), Latino (n = 1), Lebanese (n = 1), and multiracial (n = 2).
North America includes US (primary analysis population enrollment: n = 491) and Canada (n = 8). The remaining patients were enrolled from the Czech Republic (n = 40), Austria (n = 16), Italy (n = 7), France (n = 2), UK (n = 3), Kazakhstan (n = 18), and Australia (n = 4).
Percutaneous coronary intervention includes stent, balloon angioplasty, and atherectomy.
In instances in which data may be missing for some subset of patients, total numbers are provided to describe the population in which the specific data are available.
Mean arterial pressure over study follow-up period is provided in eFigure 2 in Supplement 2.
Additional laboratory values are provided in eTable 4 in Supplement 2.
Baseline medications are any exposure within the preceding 30 days prior to implant, except aspirin, which was within the preceding 7 days.
Vitamin K antagonist (VKA) agents used in patients prior to left ventricular assist device (LVAD) implant include warfarin (n = 14) and fluindione (n = 1).
Destination therapy refers to those who are ineligible for cardiac transplant.
Disease severity defined by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles, which range from 1 to 7; a profile of 1 represents the most severe illness and a profile of 7 represents the least severe illness.