Limb salvage in diabetic patients with no-option critical limb ischemia: outcomes of a specialized center experience

Figures & data

Table 1. Characteristics of the study population and univariate analysis.

	Population (n = 84)	1-year major amputation or death HR (95% CI)
Age, (years)	77 [70–84]	0.997 (0.971–1.024)
Male sex, no. (%)	58 (69)	1.540 (0.838–2.831)
BMI, (kg/m^2)	23.9 [22.0–26.1]	0.996 (0.931–1.065)
Hypertension, no. (%)	60 (71.4)	0.735 (0.426–1.268)
Dyslipidemia, no. (%)	66 (78.6)	0.831 (0.486–1.421)
Type 1 diabetes, no. (%)	3 (3.6)	0.663 (0.092–4.799)
Comorbidities
Diabetic retinopathy, no. (%)	16 (19.0)	0.942 (0.445–1.994)
Carotid artery disease, no. (%)	15 (17.9)	0.693 (0.339–1.417)
Stroke, no. (%)	7 (8.3)	1.700 (0.724–3.991)
Heart failure, no. (%)	16 (19.0)	0.724 (0.354–1.480)
Ischemic heart disease, no. (%)	46 (54.8)	1.175 (0.687–2.010)
Atrial fibrillation, no. (%)	30 (35.7)	0.706 (0.401–1.242)
Valvular prosthesis, no. (%)	12 (14.3)	1.077 (0.527–2.203)
ESRD on hemodialysis, no. (%)	16 (19.0)	1.295 (0.680–2.465)
COPD, no. (%)	11 (13.1)	1.486 (0.698–3.166)
Rheumatoid arthritis, no. (%)	12 (14.3)	0.906 (0.410–2.002)
Laboratory data
Hemoglobin, (g/dl)	10.0 [9.3–11.1]	0.780 (0.611–0.995)
White blood cells, (10^3/μL)	10.4 ± 3.4	1.081 (0.998–1.171)
Platelets, (10^3/μL)	304 [230–384]	1.001 (1.000–1.003)
Creatinine clearance, (ml/min)	54.5 [27.9–87.3]	1.002 (0.995–1.009)
Cholesterol, (mg/dl)	136.9 ± 37.0	0.991 (0.983–0.999)
HDL, (mg/dl)	32.0 [27.0–44.0]	0.983 (0.960–1.006)
Triglycerides, (mg/dl)	122.5 [97.3–156.3]	0.998 (0.992–1.004)
LDL, (mg/dl)	69.2 [51.8–101.2]	0.991 (0.982–1.001)
Hemoglobin A1c, (mmol/mol) (%)	51.0 [42.0–62.0] 6.8 [6.0–7.8]	0.979 (0.946–1.008)
CRP, (mg/dl)	5.0 [2.1–9.6]	1.043 (1.009–1.079)
Previous PAD treatment
PTA, no (%)	78 (92.9)	0.464 (0.184–1.169)
Bypass surgery, no (%)	14 (16.7)	1.054 (0.531–2.092)
Amputation*, no (%)	53 (63.1)	1.342 (0.763–2.361)
Medical therapy
Oral anticoagulants, no (%)	36 (42.9)	1.090 (0.640–1.859)
Aspirin, no (%)	76 (90.5)	1.336 (0.482–3.698)
Clopidogrel, no (%)	60 (71.4)	0.908 (0.512–1.610)
ACEi/ARBs, no (%)	27 (32.1)	0.763 (0.430–1.353)
Beta-blockers, no (%)	49 (58.3)	0.976 (0.571–1.669)
Statins, no (%)	61 (72.6)	1.068 (0.590–1.933)
High-potency statins†, no (%)	15 (17.9)	1.109 (0.559–2.203)
Ezetimibe, no (%)	4 (4.8)	1.585 (0.570–4.405)
Insulin therapy, no. (%)	67 (79.8)	0.888 (0.425–1.856)
Oral hypoglycemic drugs, no. (%)	15 (17.9)	0.988 (0.439–2.227)

ESRD, end-stage renal disease; COPD, chronic obstructive pulmonary disease; CRP, C-reactive protein; PAD, peripheral artery disease; PTA, percutaneous transluminal angioplasty; ACEi, angiotensin-converting enzyme inhibitors; ARBs, angiotensin receptor blockers.

*Any kind of amputation in either leg.

†Atorvastatin 40/80 mg or rosuvastatin 10/20/40 mg.

Table 2. Characteristics of the index lesion and univariate analysis.

	Population (n = 84)	1-year major amputation or death HR (95% CI)
Location
Digits, no (%)	17 (20.2)
Forefoot, no (%)	38 (45.2)
Midfoot, no (%)	4 (4.8)
Hindfoot, no (%)	7 (8.3)
Ankle, no (%)	3 (3.6)
Diffuse foot involvement, no (%)	11 (13.1)
Leg/residual limb, no (%)	4 (4.8)
Proximal to Lisfranc joint, no (%)	29 (34.5)	2.080 (1.221–3.545)
Characteristics
Plantar lesion, no (%)	6 (7.2)	1.120 (0.404–3.102)
Gangrene, no (%)	47 (56.0)	2.483 (0.338–18.240)
TcPO2, (mmHg)	7 [3–14]	1.001 (0.969–1.035)
Angiographic data
N° of patent tibial arteries:
3	5 (6.0)
2	15 (17.9)
1	28 (33.3)
0	36 (42.9)
N° of patent pedal arteries:
2	0 (0)
1	14 (16.7)
0	70 (83.3)

TcPO2, transcutaneous oxygen tension.

Figure 1. Occurrence of major amputation or death in patients with lesions located proximal or distal to the Lisfranc joint.

Figure 2. Occurrence of death in patients treated with major amputation and in those who had a successful limb salvage.