Table 1.
Patient Characteristics in the VICTORIA Trial and the GWTG-HF Registry
| Variable | VICTORIA Trial Population (RCT) | VICTORIA Eligible Patients (GWTG-HF) | FDA Label Patients (GWTG-HF) | Hospitalized HF with EF<45% (GWTG-HF) | Standardized Differences | ||
|---|---|---|---|---|---|---|---|
|
N=5,050 |
[A] N=92,249 |
[B] N=221,730 |
[C] N=241,057 |
[A] vs [B] | [A] vs [C] | [B] vs [C] | |
| Demographics | |||||||
| Age, median (25th, 75th) | 69 (60–76) | 72 (61 – 82) | 70 (58 – 80) | 69 (58 – 80) | 15.3 | 16.8 | 1.4 |
| Female | 2.7 | 2.4 | 0.4 | ||||
| Female | 1208 (23.9) | 33,459 (36.3) | 77,513 (35.0) | 84,710 (35.1) | |||
| Race/Ethnicity | 8.6 | 10.1 | 1.9 | ||||
| White | 3239 (64.1) | 60,152 (65.2) | 135,906 (61.3) | 145,757 (60.5) | |||
| Black | 249 (4.9) | 20,758 (22.5) | 57,402 (25.9) | 63,338 (26.3) | |||
| Hispanic | N/R | 7,287 (7.9) | 18,044 (8.1) | 20,175 (8.4) | |||
| Asian | 1,132 (22.4) | 1,392 (1.5) | 3,555 (1.6) | 4,177 (1.7) | |||
| Other | 430 (8.5) | 2,660 (2.9) | 6,823 (3.1) | 7,610 (3.2) | |||
| Insurance Status | 11.8 | 11.1 | 1.2 | ||||
| Medicare - Private/HMO/Other | N/R | 3,506 (4.1) | 12,179 (6.0) | 12,658 (5.7) | |||
| Medicare | N/R | 43,919 (51.9) | 95,581 (47.1) | 104,185 (47.3) | |||
| Medicaid | N/R | 14,537 (17.2) | 38,602 (19.0) | 42,356 (19.2) | |||
| Private/HMO/Other | N/R | 22,609 (26.7) | 56,761 (27.9) | 61,279 (27.8) | |||
| Medical History | |||||||
| Ejection fraction, % | 30 (23–35) | 28 (20 – 35) | 27 (20 – 35) | 27 (20 – 35) | 7.2 | 5.4 | 1.7 |
| AFib/Flutter medical history | 2269 (45.0) | 39,743 (43.1) | 80,693 (37.3) | 86,708 (36.8) | 11.9 | 13.0 | 1.0 |
| AFib/Flutter at presentation or during hospitalization | NR | 30,063 (32.6) | 64,765 (29.2) | 69,305 (28.8) | 7.3 | 8.3 | 1.0 |
| COPD or Asthma | 863 (17.1) | 31,974 (34.7) | 70,872 (32.8) | 76,766 (32.6) | 4.1 | 4.5 | 0.4 |
| Depression | N/R | 13,029 (14.1) | 30,502 (14.1) | 33,492 (14.2) | 0.1 | 0.2 | 0.3 |
| Prior MI | N/R | 25,016 (27.1) | 56,135 (25.9) | 61,671 (26.2) | 2.7 | 2.2 | 0.5 |
| Peripheral Vascular Disease | 630 (12.5) | 11,135 (12.1) | 24,264 (11.2) | 27,590 (11.7) | 2.7 | 1.2 | 1.6 |
| Hyperlipidemia | N/R | 54,101 (58.7) | 120,894 (55.9) | 132,226 (56.1) | 5.7 | 5.3 | 0.5 |
| Hypertension | 3,993 (79.1) | 77,903 (84.5) | 180,707 (83.5) | 197,509 (83.8) | 2.8 | 2.0 | 0.8 |
| Diabetes | 2,377 (47.1) | 42,386 (46.0) | 97,645 (44.6) | 109,143 (45.8) | 2.9 | 0.4 | 2.4 |
| Chronic kidney disease | N/R | 19,285 (20.9) | 43,315 (20.0) | 56,936 (24.2) | 2.3 | 7.7 | 10.0 |
| Dialysis, Chronic | 0 (0.0) | 0 (0.0) | 0 (0.0) | 8,580 (3.6) | 0.0 | 27.5 | 27.5 |
| Prior PCI | N/R | 21,034 (22.8) | 47,406 (21.9) | 52,057 (22.1) | 2.2 | 1.8 | 0.4 |
| Prior CABG | N/R | 21,382 (23.2) | 44,934 (20.8) | 49,286 (20.9) | 5.9 | 5.5 | 0.4 |
| CRT | 739 (14.7) | 10,428 (13.6) | 21,683 (11.6) | 23,511 (11.6) | 6.0 | 6.0 | 0.0 |
| Ischemic Etiology | N/R | 57,974 (62.9) | 125,103 (57.8) | 137,013 (58.1) | 10.4 | 9.8 | 0.7 |
| Smoking | N/R | 17,813 (19.3) | 49,802 (22.5) | 53,113 (22.0) | 7.8 | 6.7 | 1.0 |
| Discharge Vital Signs and Laboratory Values | |||||||
| Heart rate, bpm | 72 (64–81) | 77 (68 – 88) | 78 (69 – 88) | 78 (69 – 88) | 5.1 | 5.1 | 0.0 |
| Systolic blood pressure, mmHg | 119 (109–131) | 119 (109 – 132) | 117 (105 – 131) | 117 (105 – 132) | 18.3 | 16.1 | 1.9 |
| BMI, kg/m2 | 26.8 (23.7–30.9) | 27.8 (23.7 – 33.2) | 27.9 (23.7 – 33.5) | 27.8 (23.7 – 33.4) | 2.3 | 1.3 | 1.0 |
| eGFR, mL/min/1.73 | 58 (41–77) | 55 (39 – 75) | 57 (39 – 77) | 54 (35 – 75) | 4.0 | 8.3 | 11.9 |
| Potassium, mEq/L | 4.5 (4.2–4.8) | 4.0 (3.7 – 4.4) | 4.0 (3.7 – 4.4) | 4.1 (3.8 – 4.4) | 2.5 | 6.5 | 4.1 |
| BNP, pg/mL | 747.9 (452.4–1,340) | 1,248 (725 – 2,261) | 1,112 (562 – 2,118) | 1,160 (581 – 2,253) | 18.3 | 12.9 | 4.8 |
| NT-proBNP, pg/mL | 3,377 (1,992–6,380) | 6,738 (3,359 – 13,800) | 6,193 (2,888 – 13,062) | 6,663 (3,033 – 14,758) | 10.5 | 2.7 | 7.3 |
| Hospital Characteristics | |||||||
| Number of Beds | N/R | 381 (250 – 549) | 394 (259 – 581) | 394 (260 – 581) | 7.6 | 8.3 | 0.7 |
| Geographic Region | 5.4 | 5.6 | 0.3 | ||||
| West | N/R | 15,573 (16.9) | 40,766 (18.4) | 44,564 (18.5) | |||
| South | N/R | 30,762 (33.3) | 75,187 (33.9) | 81,631 (33.9) | |||
| Midwest | N/R | 18,838 (20.4) | 45,299 (20.4) | 49,188 (20.4) | |||
| Northeast | N/R | 27,070 (29.3) | 60,470 (27.3) | 65,664 (27.2) | |||
| Rural Location | N/R | 2,997 (3.2) | 6,276 (2.8) | 6,671 (2.8) | 2.4 | 2.8 | 0.4 |
| Teaching Status | N/R | 73,808 (81.0) | 179,596 (81.8) | 195,581 (82.0) | 2.2 | 2.6 | 0.4 |
| Heart Transplant Hospital | N/R | 5,506 (8.1) | 17,100 (10.5) | 19,711 (11.1) | 8.4 | 10.3 | 2.0 |
Data represent median (25th – 75th) or n (%).
*
Data reflect the proportion of patients within each group that were enrolled from various types of hospitals.
Abbreviations: EF, ejection fraction; BMI, body mass index; BNP, B-type natriuretic peptide; CABG, coronary artery bypass grafting; COPD, chronic obstructive pulmonary disease; CRT, cardiac resynchronization therapy; eGFR, estimated glomerular filtration rate; HMO, health maintenance organization; ICD, implantable cardioverter-defibrillator; MI, myocardial infarction; NT-proBNP, N-terminal pro-B-type natriuretic peptide; PCI, percutaneous coronary intervention; TIA, transient ischemic attack.