Table 2.
Baseline demographic and clinical characteristics of patients in the FAS (categorical data)
| Variable | No. of patients | Total | Treatment group |
P | |
|---|---|---|---|---|---|
| AMG0102 n (%) |
PTA n (%) |
||||
| 168 | 111 (66.1) | 57 (33.9) | |||
| Age, yr | <65 | 61 | 46 (75.4) | 15 (24.6) | 0.054a |
| ≥65 | 107 | 65 (60.7) | 42 (39.3) | ||
| Sex | Male | 122 | 82 (67.2) | 40 (32.8) | 0.611a |
| Female | 46 | 29 (63.0) | 17 (37.0) | ||
| Diabetes complications | Absent | 86 | 58 (67.4) | 28 (32.6) | 0.701a |
| Present | 82 | 53 (64.6) | 29 (35.4) | ||
| Target lesion site of interest (treatment site) | Vein near anastomosis | 101 | 66 (65.3) | 35 (34.7) | — |
| Superficial forearm vein (internal shunt main vein) | 82 | 55 (67.1) | 27 (32.9) | ||
| Superficial brachial vein (internal shunt main vein) | 15 | 10 (66.7) | 5 (33.3) | ||
| Deep brachial vein | 0 | 0 | 0 | ||
| Central vein | 1 | 1 (100) | 0 | ||
| Smoking history | No smoking history | 75 | 49 (65.3) | 26 (34.7) | 0.965a |
| Previously smoked | 77 | 51 (66.2) | 26 (33.8) | ||
| Currently smoking | 16 | 11 (68.8) | 5 (31.25) | ||
| Number of shunt constructions | Once | 119 | 80 (67.2) | 39 (32.8) | 0.622a |
| Twice or more | 49 | 31 (63.3) | 18 (36.7) | ||
| Shunt site | Left | 129 | 88 (68.2) | 41 (31.8) | 0.285a |
| Right | 39 | 23 (59.0) | 16 (41.0) | ||
| Shunt anastomosis method | Side-end anastomosis | 119 | 77 (64.7) | 42 (35.3) | — |
| Side-side anastomosis | 31 | 22 (71.0) | 9 (29.0) | ||
| End-end anastomosis | 1 | 0 | 1 (100) | ||
| Other | 17 | 12 (70.6) | 5 (29.4) | ||
| Weekly dialysis frequency | <3 times | 7 | 6 (85.7) | 1 (14.3) | — |
| 3 times | 161 | 105 (65.2) | 56 (34.8) | ||
| 4 times | 0 | 0 | 0 | ||
| ≥5 times | 0 | 0 | 0 | ||
| Target lesion site of interest | Initial onset | 61 | 43 (70.5) | 18 (29.5) | — |
| Recurrence | 107 | 68 (63.6) | 39 (36.4) | ||
| Unknown | 0 | 0 | 0 | ||
| Type of previous treatment in case of recurrence | PTA balloon | 107 | 68 (63.6) | 39 (36.4) | — |
| Other | 0 | 0 | 0 | ||
| Stenosis of access circuit | Absent | 118 | 82 (69.5) | 36 (30.5) | 0.150a |
| Present | 50 | 29 (58.0) | 21 (42.0) | ||
| Stenting at site other than target lesion | Absent | 167 | 110 (65.9) | 57 (34.1) | 1.000b |
| Present | 1 | 1 (100) | 0 | ||
| Etiology of dialysis | Diabetic nephropathy | 89 | 58 (65.2) | 31 (34.8) | — |
| Chronic glomerulonephritis | 23 | 14 (60.9) | 9 (39.1) | ||
| Nephrosclerosis | 32 | 22 (68.8) | 10 (31.3) | ||
| Rapidly progressive glomerulonephritis | 1 | 1 (100) | 0 | ||
| Polycystic kidney disease | 6 | 5 (83.3) | 1 (16.7) | ||
| Chronic pyelonephritis | 1 | 1 (100) | 0 | ||
| Other | 27 | 16 (59.3) | 11 (40.7) | ||
| Diabetes mellitus | Absent | 65 | 43 (66.2) | 22 (33.8) | 0.986a |
| Present | 103 | 68 (66.0) | 35 (34.0) | ||
| Diabetes treatment | Insulin therapy | 45 | 27 (60.0) | 18 (40.0) | — |
| Oral diabetes medication | 54 | 38 (70.4) | 16 (29.6) | ||
| Dietary therapy alone | 9 | 5 (55.6) | 4 (44.4) | ||
| Untreated | 12 | 10 (83.3) | 2 (16.7) | ||
| Other | 12 | 10 (83.3) | 2 (16.7) | ||
| Hyperlipidemia | Absent | 87 | 57 (65.5) | 30 (34.5) | 0.875a |
| Present | 81 | 54 (66.7) | 27 (33.3) | ||
| Hyperlipidemia treatment | Resolved | 2 | 1 (50.0) | 1 (50.0) | 1.000b |
| Ongoing morbidity | 79 | 53 (67.1) | 26 (32.9) | ||
| Drug treatment absent | 28 | 21 (75.0) | 7 (25.0) | ||
| Drug treatment present | 51 | 32 (62.7) | 19 (37.3) | ||
| Hypertension | Absent | 9 | 8 (88.9) | 1 (11.1) | 0.276b |
| Present | 159 | 103 (64.8) | 56 (35.2) | ||
| Hypertension treatment | Resolved | 0 | 0 | 0 | — |
| Ongoing morbidity | 159 | 103 (64.8) | 56 (35.2) | ||
| Drug treatment absent | 15 | 13 (86.7) | 2 (13.3) | ||
| Drug treatment present | 144 | 90 (62.5) | 54 (37.5) | ||
| Other past history | Absent | 96 | 70 (72.9) | 26 (27.1) | 0.030a |
| Present | 72 | 41 (56.9) | 31 (43.1) | ||
| Other concomitant illness | Absent | 0 | 0 | 0 | — |
| Present | 168 | 111 (66.1) | 57 (33.9) | ||
| Allergy to heparin | Absent | 168 | 111 (66.1) | 57 (33.9) | — |
| Present | 0 | 0 | 0 | ||
| Allergy to contrast agent | Absent | 164 | 109 (66.5) | 55 (33.5) | 0.605b |
| Present | 4 | 2 (50.0) | 2 (50.0) | ||
| 12-lead ECG | No abnormality | 98 | 67 (68.4) | 31 (31.6) | 0.417a |
| Abnormality present | 69 | 43 (62.3) | 26 (37.7) | ||
With and without diabetes mellitus complications: a patient who received insulin preparation or oral hypoglycemic agents when obtaining consent was regarded as having diabetes mellitus complications.
Diabetes mellitus: in addition to the described above, the patient who received diet and exercise therapy was regarded as having diabetes mellitus.
ECG, electrocardiogram; FAS, full analysis set; PTA, percutaneous transluminal angioplasty.
a
χ2 test.
b
Fisher exact test.