Table 1. Baseline Characteristics of the Patients.
| Characteristic | Therapeutic dose of heparin plus P2Y12 inhibitor (n = 293) |
Therapeutic dose of heparin only (usual care) (n = 269) |
|---|---|---|
| Age, mean (SD), y | 53.1 (14.1) | 52.3 (12.9) |
| Sex, No. (%) | ||
| Female | 124 (42.3) | 109 (40.5) |
| Male | 169 (57.7) | 160 (59.5) |
| Race, No. (%)a | (n = 269) | (n = 246) |
| American Indian or Alaska Native | 10 (3.7) | 8 (3.3) |
| Asian | 7 (2.6) | 9 (3.7) |
| Black | 68 (25.3) | 67 (27.2) |
| Multiple races | 3 (1.1) | 0 |
| Native Hawaiian or Pacific Islander | 2 (0.7) | 2 (0.8) |
| White | 167 (62.1) | 152 (61.8) |
| Other | 12 (4.5) | 8 (3.3) |
| Hispanic, No./total (%)b | 69/214 (32.2) | 48/193 (24.9) |
| Hospital site location, No. (%) | ||
| Brazil | 67 (22.9) | 70 (26.0) |
| Italy | 1 (0.3) | 1 (0.4) |
| Spain | 44 (15.0) | 41 (15.2) |
| US | 181 (61.8) | 157 (58.4) |
| Enrichment criteriac | ||
| D-dimer level ≥2-fold the ULN, No./total (%) | 105/262 (40.1) | 100/234 (42.7) |
| Age, No. (%) | ||
| ≥60 y | 96 (32.8) | 73 (27.1) |
| <60 y with an oxygen level >2 L/min or ≥1 comorbidityd | 178 (60.8) | 180 (66.9) |
| Body mass indexe | (n = 283) | (n = 265) |
| Median (IQR) | 31.4 (27.1-36.8) | 31.6 (27.5-37.9) |
| >30, No. (%) | 164 (58.0) | 152 (57.4) |
| Cardiovascular disease, No. (%)f | 128 (43.7) | 150 (55.8) |
| Hypertension | 125 (42.7) | 147 (54.9)g |
| Heart failure | 12 (4.1) | 11 (4.1)g |
| Coronary artery disease | 15 (5.1) | 17 (6.3)g |
| Peripheral arterial disease | 1 (0.3) | 2 (0.7) |
| Cerebrovascular disease | 1 (0.3) | 3 (1.1)g |
| Other diseases and chronic conditions, No. (%) | ||
| Diabetes | 72 (24.6) | 73 (27.1) |
| Chronic kidney disease | 11 (3.8) | 11 (4.1) |
| Liver disease | 4 (1.4) | 8 (3.0) |
| Respiratory disease | 56 (19.1) | 37 (13.8) |
| Asthma | 39 (13.3) | 24 (8.9) |
| COPD | 17 (5.8) | 13 (4.8) |
| Baseline treatment, No. (%) | ||
| Glucocorticoids | 192 (65.5) | 168 (62.5) |
| Remdesivir | 164 (56.0) | 128 (47.6) |
| Aspirin | 44 (15.0) | 36 (13.4) |
| Anticoagulant therapy | 31 (10.6) | 39 (14.5) |
| IL-6 inhibitors | 8 (2.7) | 8 (3.0) |
| Respiratory support, No. (%)h | (n = 262) | (n = 238) |
| None | 32 (12.2) | 26 (10.9) |
| Low-flow nasal cannula, L/min | ||
| 0-2 | 80 (30.5) | 77 (32.4) |
| 2-4 | 91 (34.7) | 95 (39.9) |
| >4 | 57 (21.8) | 39 (16.4) |
| High-flow nasal cannula (20-40 L/min) | 2 (0.8) | 1 (0.4) |
| Laboratory values, median (IQR)i | ||
| D-dimer, μg/mL | (n = 262); 1.017 (0.598-1.780) | (n = 234); 1.060 (0.640-2.080) |
| C-reactive protein, mg/L | (n = 237); 93.8 (50.4-153) | (n = 224); 93.0 (57.5-139) |
| Creatinine, mg/dL | (n = 288); 0.84 (0.71-1.00) | (n = 265); 0.85 (0.71-1.07) |
| Hemoglobin, g/dL | (n = 292); 13.6 (12.6-14.6) | (n = 268); 13.7 (12.6-14.9) |
| White blood cell count, ×109/L | (n = 269); 0.86 (0.62-1.20) | (n = 247); 0.91 (0.67-1.30) |
| Platelet count, ×103/μL | (n = 291); 211 (163-274) | (n = 268); 217 (170-281) |
Abbreviations: COPD, chronic obstructive pulmonary disease; ULN, upper limit of normal.
SI conversion factors: To convert creatinine to μmol/L, multiply by 88.4; D-dimer to nmol/L, multiply by 5.476.
Self-reported from either the patients or their surrogates via fixed categories appropriate to their country and region.
Excludes patients in Brazil.
Criteria chosen to enrich for events in non–critically ill patients.
Comorbidities included oxygen level greater than 2 L/min, diabetes, hypertension, chronic kidney disease, cardiovascular disease, or body mass index of 35 or greater.
Calculated as weight in kilograms divided by height in meters squared.
Data were systematically collected using predefined questions.
The denominator is 268.
Home oxygen therapy used to support patients with asthma, chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, lung cancer, pulmonary hypertension, and tuberculosis.
The normal ranges differed by hospital site because each site was allowed to determine the ranges for the assays.