Table 3.
Baseline characteristics of patients who had a lower-limb amputation, by presence of large-vessel disease
| Minor amputation without large-vessel disease (n=39) | Major or minor amputation with large-vessel disease (n=76)* | p value† | |||
|---|---|---|---|---|---|
| Male | 30 (77%) | 63 (83%) | 0·441 | ||
| Age at visit 1 (years) | 63 (6) | 66 (6) | 0·019 | ||
| Diabetes duration (years) | 11 (7–22) | 9 (4–15) | 0·041 | ||
| Body-mass index (kg/m2) | 30·9 (28·7–36·4) | 28·6 (25·8–32·0) | 0·004 | ||
| Waist–hip ratio | 0·97 (0·90–1·00) | 0·96 (0·91–1·00) | 0·690 | ||
| Height (cm) | 174 (8) | 173 (8) | 0·278 | ||
| Systolic blood pressure (mm Hg) | 143 (12) | 145 (16) | 0·455 | ||
| Diastolic blood pressure (mm Hg) | 83 (7) | 81 (9) | 0·166 | ||
| Current smoker | 6 (15%) | 17 (22%) | 0·375‡ | ||
| Ex-smoker | 20 (51%) | 41 (54%) | |||
| Clinical history | |||||
| Previous amputation or diabetic skin ulcer | 15 (38%) | 20 (26%) | 0·180 | ||
| Previous cardiovascular disease§ | 17 (44%) | 50 (66%) | 0·022 | ||
| Previous MI, angina, CABG, or PTCA | 8 (21%) | 26 (34%) | 0·128 | ||
| Stroke | 2 (5%) | 10 (13%) | 0·182 | ||
| Peripheral vascular disease | 11 (28%) | 32 (42%) | 0·145 | ||
| Microvascular disease | 29 (74%) | 36 (47%) | 0·006 | ||
| Retinopathy | 14 (36%) | 20 (26%) | 0·286 | ||
| Neuropathy | 26 (67%) | 31 (41%) | 0·009 | ||
| Nephropathy | 2 (5%) | 6 (8%) | 0·581 | ||
| Laboratory data¶ | |||||
| Total cholesterol (mmol/L) | 5·03 (0·66) | 4·86 (0·63) | 0·187 | ||
| LDL cholesterol (mmol/L) | 3·09 (0·67) | 2·95 (0·68) | 0·294 | ||
| HDL cholesterol (mmol/L) | 1·00 (0·25) | 1·07 (0·27) | 0·179 | ||
| Triglycerides (mmol/L) | 1·95 (1·39–2·49) | 1·69 (1·28–2·23) | 0·225 | ||
| Plasma haemoglobin A1c (%) | 8·1% (7·0–9·2) | 7·4% (6·7–8·5) | 0·087 | ||
| Plasma creatinine (μmol/L) | 84 (18) | 86 (19) | 0·640 | ||
| Homocysteine (μmol/L) | 10·8 (8·8–12·8) | 11·6 (9·2–14·1) | 0·266 | ||
| Dyslipidaemia‖ | 18 (46%) | 28 (37%) | 0·335 | ||
| Microalbuminuria** | 14 (36%) | 32 (42%) | 0·520 | ||
| Macroalbuminuria†† | 10 (26%) | 10 (13%) | 0·095 | ||
| Baseline blood-glucose-lowering medication | |||||
| Diet alone | 1 (3%) | 7 (9%) | 0·185 | ||
| Metformin alone | 3 (8%) | 7 (9%) | 0·784 | ||
| Sulphonylurea alone | 2 (5%) | 10 (13%) | 0·182 | ||
| Metformin and sulphonylurea | 18 (46%) | 22 (29%) | 0·067 | ||
| Other oral agent alone | 0 (0%) | 0 (0%) | .. | ||
| Metformin or sulphonylurea or both and other agent | 3 (8%) | 2 (3%) | 0·208 | ||
| Insulin alone | 5 (13%) | 13 (17%) | 0·549 | ||
| Insulin and oral agent | 7 (18%) | 15 (20%) | 0·817 | ||
Data are number (%), mean (SD), or median (IQR). CABG=coronary artery bypass graft. MI=myocardial infarction. PTCA=percutaneous transluminal coronary angioplasty.
13 patients who had a minor amputation without large-vessel disease plus another type of amputation are included in this group.
p values are from χ2 tests for categorical variables, t test for normally distributed continuous variables, or Wilcoxon rank-sum test for non-normally distributed continuous variables.
p value from three-way χ2 test of current smokers, ex-smokers, and non-smokers.
Previous cardiovascular disease comprises previous MI, angina, CABG, PTCA, stroke, peripheral vascular disease, or revascularisation.
Mean of pre-randomisation visits for lipids, haemoglobin A1c, and creatinine.
Men: HDL cholesterol concentration <1·03 mmol/L and triglyceride concentration ≥1·7 mmol/L; women: HDL cholesterol concentration <1·29 mmol/L and triglyceride concentration ≥1·7 mmol/L.
Microalbuminuria defined as urine albumin/creatinine ratio ≥2·5 mg/mmoL and <25 mg/mmoL for men, and ≥3·5 mg/mmoL and <35 mg/mmoL for women.
Macroalbuminuria defined as urine albumin/creatinine ratio ≥25 mg/mmoL for men and ≥35 mg/mmoL for women.