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. 2025 Mar 13;11(1):2476881. doi: 10.1080/20565623.2025.2476881

Risk factors of major lower limb amputation in symptomatic peripheral artery disease: a retrospective cohort study

Supatcha Prasertcharoensuk a, Krittin Prateepphuangrat a, Phati Angkasith a, Panu Teeratakulpisarn a, Parichat Tanmit a, Saowapa Chimluang b, Kittisak Sawanyawisuth c,✉, Narongchai Wongkonkitsin a,✉
PMCID: PMC11916367  PMID: 40079894

Abstract

Aim

To find risk factors of major amputation in patients with peripheral artery disease (PAD) by a combination of both personal risk factors and treatment.

Methods

This was a retrospective cohort study enrolled adult patients diagnosed as symptomatic PAD. Predictors for major amputation were analyzed.

Results

There were 221 patients with PAD met the study criteria; 28 patients (12.67%) had major amputation events. There were three independent factors Rutherford classification, white blood cell, and serum albumin. The adjusted odds ratio (95% confidence interval) of these factors were 1.824 (1.118, 2.976), 1.073 (1.019, 1.131), and 0.421 (0.202, 0.879), respectively.

Conclusions

Serum albumin was modifiable to prevent future major amputation in patients with PAD.

Keywords: Albumin, white blood cell, severity, peripheral artery disease, Rutherford classification

PLAIN LANGUAGE SUMMARY

Peripheral artery disease, is considered a major cardiovascular disease, may cause limb loss. Among 221 patients with peripheral artery disease, the rate of major amputations was 12.67%. Important risk factors for major amputations in patients with peripheral artery disease were severity of peripheral artery disease, white blood cell level, and albumin level.

Article highlights

  • Peripheral artery disease may cause major limb amputations.

  • Lower serum albumin was associated with higher major amputation risk in patients with symptomatic PAD.

  • Serum albumin level of less than 2.7 g/dL had sensitivity of 81.48% for major amputations in patients with peripheral artery disease.

Peripheral artery disease (PAD) is an atherosclerotic disease of medium and large-sized arteries. Over 200 million people may have PAD worldwide with a substantial rising in prevalence with a prevalence of 29% in those high-risk individuals such as age of 70 years or more or age between 50 and 69 years with history of diabetes or smoking [1]. The prevalence of PAD may vary among ethnicities. A previous study found that African Americans had higher risk of PAD than Caucasian by 50%, while Chinese had lower risk by 50% [2]. Diabetes and smoking are major risk factors for PAD for 2–4 times [3,4]. It has been shown that PAD is a predictor of future heart failure with relative risk of 1.90 (95% confident interval of 1.68, 1.94) [5]. Additionally, Patients with coronary heart disease without diabetes increases risk of PAD by 2.06 times [6].

A guideline by Society for vascular Surgery recommends both nonintervention and intervention treatments for those symptomatic PAD [7]. One of aims of PAD treatment is to prevent future limb amputation which is 3–4% in overall [8,9]. A study from Canada found that major amputation rate in patients with PAD was 4.92/100000 [10]. Patients with symptomatic PAD were at risk for major amputation and mortality by 22% [11]. Several risk factors have been shown to be related with major amputation in patients with PAD including diabetes, history of amputation, Rutherford severity score, or co-morbid diseases such as coronary heart disease [12–16]. Other studies showed beneficial effects of treatment on prevention of limb amputation [17,18].

In addition to Rutherford score, some laboratory factors such as albumin or white blood cell may be related to atherosclerosis or PAD [19,20]. A previous study found that low serum albumin was associated with PAD in hypertensive patients with odds ratio of 1.45 (95% confidence interval of 1.08, 1.96). Another study also showed that white blood cell, an indicator of inflammation, was correlated with PAD if more than 6.75 x 109/L [21]. Even though these laboratory factors were shown to be associated with PAD diagnosis. There is limited data on the correlation of the laboratory factors and major amputation in patients with PAD. This study aimed to evaluate if laboratory factors could be potential predictors for major amputation in patients with symptomatic PAD.

1. Methods

This was a retrospective cohort study conducted at Department of Surgery, Faculty of Medicine, Khon Kaen University, Thailand. The inclusion criteria were adult patients diagnosed as symptomatic PAD. Those who were pregnant, did not receive any treatment/denial to treatment, or unavailable clinical data were excluded. The diagnosis of PAD was made by an ankle brachial index of less than 0.9 in those with symptoms of intermittent claudication, limb gangrene, rest pain in lower extremities, or unhealed foot ulcer [19,22]. The study period was between 2008 and 2018.

Eligible patients were selected from the hospital database. We reviewed charts of eligible patients and recorded baseline characters, laboratory results, and treatment. Baseline characters included age, sex, body mass index, co-morbid diseases, personal factors, and symptoms/severity of PAD including Rutherford classification, while treatments were both medical and surgical treatments. The primary outcome of the study was major amputation event: defined by above knee or below knee amputation after receiving care at our hospital. The amputations below the ankle such as toe amputation or partial foot amputation were considered non-major amputation [23]. Note that the dataset owner is Faculty of Medicine, Khon Kaen University, Thailand and the authors received permission to use the data for this study.

Statistical analyses. Eligible patients were categorized into two groups by major amputation event. Descriptive statistics were used to calculate differences between these two groups. Predictors for major amputation were analyzed by logistic regression analysis. A univariate logistic analysis was used to execute an unadjusted odds ratio with 95% confidence interval and a p value of each factor. Factors with a p value by univariate logistic regression analysis of less than 0.20 or clinically important factors such as smoking were put in the subsequent stepwise, multivariate logistic regression analysis. The final model for predictive of major amputation was tested for goodness of fit by Hosmer–Lemeshow method. A numerical predictor for major amputation was computed for appropriate diagnostic cut off point by a receiver operating characteristic (ROC) curve. Sensitivity and specificity for the best cut off point for major amputation were reported. All statistical analyses were performed using STATA software version 10.1 (College Station, Texas, USA).

2. Results

During the study period, 221 patients with PAD met the study criteria. Of those, 28 patients (12.67%) had major amputation events. There were two significant factors between those with and without major amputation regarding baseline characteristics: age and previous major amputation (Table 1). The major amputation group had significantly older age (71 vs 65 years; p 0.044) and more patients with previous major amputation (25% vs 1.19%; p < 0.001) than the non-major amputation group.

Table 1.

Baseline characters of patients with peripheral artery disease (PAD) categorized by major amputation occurrence (MA).

Factors No MA
n = 193		 MA
n = 28		 P-value
Age, year 65 (24–96) 71 (38–88) 0.039
 Male 124 (64.25) 17 (60.71) 0.834
 BMI, kg/m2 21.30 (11.86–40.63) 21.50 (14.84–34.94) 0.849
Co-morbid diseases      
 Diabetes 79 (40.93) 15 (53.57) 0.225
 Hypertension 97 (50.26) 14 (50.00) 0.999
 Dyslipidemia 63 (32.64) 10 (35.71) 0.830
 On dialysis 13 (6.77) 1 (3.57) 0.999
 CAD 43 (22.28) 3 (10.71) 0.215
 Stroke 10 (5.18) 1 (3.57) 0.999
 Renal artery stenosis 1 (0.52) 0 0.999
Personal factors      
 Smoking 10 (8.85) 1 (6.25) 0.999
 Ex-smoking 13 (6.74) 2 (7.14) 0.999
 Smoking, pack-year 20 (2–50) 20 (20–40) 0.260
 Alcohol consumption 2 (1.04) 0 0.999
 Herb use 1 (0.52) 0 0.999
Symptoms of PAD      
 Limb gangrene 67 (34.72) 13 (46.43) 0.293
 Rest pain 94 (48.70) 14 (50.00) 0.999
 Unhealed foot ulcer 86 (44.56) 14 (50.00) 0.686
 Claudication 29 (9.90) 1 (3.57) 0.139
Severity of PAD      
 Previous minor amputation 25 (13.09) 4 (18.18) 0.512
 Previous major amputation 2 (1.19) 6 (25.00) < 0.001
Rutherford classification     0.112
 1 3 (1.55) 0  
 2 6 (3.11) 0  
 3 20 (10.36) 1 (3.57)  
 4 51 (26.42) 3 (10.71)  
 5 49 (25.39) 7 (25.00)  
 6 64 (33.16) 17 (60.71)  
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Note. Data presented as median (range) or number (percentage); *excludes other causes such as medication or infection; Data presented as number (percentage) unless indicated otherwise; BMI: body mass index.

For laboratory tests and treatments, there were four significant factors between both groups: hemoglobin, white blood cell, prothrombin time, and albumin level (Table 2). The major amputation group had higher white blood cell (11.5 vs 8.9 × 103/mm3), prothrombin time (12.0 vs 11.4 min) than the non-major amputation group but lower hemoglobin level (9.4 vs 10.9 g/dL) and albumin level (3.3 vs 3.7 g/dL).

Table 2.

Laboratory results and treatments of patients with peripheral artery disease categorized by major amputation occurrence (MA).

Factors No MA
n = 193		 MA
n = 28		 P-value
Hb, g/dL 10.9 (5.9–18.0) 9.4 (5.6–16.9) 0.007
WBC, ×103/mm3 8.9 (3.2–50.8) 11.5 (1.5–44.0) 0.009
PT, min 11.4 (9.2–25.5) 12.0 (9.9–33.0) 0.035
PTT, min 32.1 (19.0–133.0) 31.2 (22.2–160.0) 0.656
Cholesterol, mg/dL 155 (77–683) 160 (91–292) 0.572
HDL-c, mg/dL 44 (11–95) 44 (22–79) 0.932
LDL-c, mg/dL 91 (15–512) 95 (23–217) 0.391
Triglyceride, mg/dL 110 (46–497) 119 (59–283) 0.224
GFR, ml/min/1.73m2 56 (3–215) 46 (10–142) 0.441
Albumin, g/dL 3.7 (1.9–5.2) 3.3 (1.6–4.6) 0.006
A1C, % 6.3 (4.2–15.3) 6.9 (4.5–12.0) 0.259
Glucose, mg/dL 108 (61–472) 121 (64–329) 0.182
Treatment      
Aspirin 159 (82.38) 20 (71.43) 0.197
Clopidogrel 63 (32.64) 6 (21.43) 0.280
Cilostazol 20 (10.36) 0 0.085
Heparin 8 (4.15) 2 (7.14) 0.369
Warfarin 20 (10.36) 1 (3.57) 0.487
Statin 153 (79.27) 18 (64.29) 0.091
Thromboendarterectomy 13 (6.74) 2 (7.14) 0.999
Arterial bypass 34 (17.62) 2 (7.14) 0.270
Endovascular treatment 95 (49.22) 13 (46.43) 0.841
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Note. Data presented as median (range) or number (percentage); Hb: hemoglobin; WBC: white blood cell; PT: prothrombin time; PTT: partial thromboplastin time; HDL-c: high density lipoprotein cholesterol; LDL-c:: low density lipoprotein cholesterol; GFR: glomerular filtration rate.

Among 11 factors included in the predictive model for major amputation, there were five factors remaining in the final model (Table 3). Of those, three factors were independently associated with major amputation: Rutherford classification, white blood cell, and albumin. The first two factors were predictors for major amputation, while albumin was a protective factor. The adjusted odds ratio (95% confidence interval) of these factors were 1.824 (1.118, 2.976), 1.073 (1.019, 1.131), and 0.421 (0.202, 0.879), respectively. White blood cell level of more than 7,100 cells/mm3 had sensitivity of 82.14% and specificity of 30.3% for major amputation, while albumin level of less than 2.7 g/dL had sensitivity of 81.48% and specificity of 2.17% for major amputation. The ROC of both factors was shown as Figures 1 and 2 with area under the ROC of 65.22% and 66.23%, respectively.

Table 3.

Factors associated with obstructive sleep apnea in hypertensive patients according to logistic regression analysis.

Factors Unadjusted odds ratio
(95% confidence interval)		 Adjusted odds ratio
(95% confidence interval)
Age 1.027 (0.993, 1.063) 1.034 (0.994, 1.077)
Rutherford classification 2.000 (1.251, 3.199) 1.824 (1.118, 2.976)
White blood cell, ×103/mm3 1.071 (1.019, 1.126) 1.073 (1.019, 1.131)
Albumin 0.343 (0.175, 0.672) 0.421 (0.201, 0.879)
Statin 0.470 (0.202, 1.098) 0.550 (0.211, 1.432)
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Note. Factors in the model included age, gender, body mass index, smoking, Rutherford Classification, hemoglobin, white blood cell, prothrombin time, albumin, aspirin, statin.

Figure 1.

Figure 1.

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A receiver operating characteristic curve of white blood cell for major amputation in patients with peripheral artery disease.

Figure 2.

Figure 2.

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A receiver operating characteristic curve of serum albumin for major amputation in patients with peripheral artery disease.

3. Discussion

This study found that personal factors were stronger risk factors for major amputation in patients with PAD than treatment. Serum albumin is a modifiable, independent predictor for major amputation in patients with symptomatic PAD (Table 3). Either surgical or medical treatment were independently associated with major amputation in patients with PAD compared with personal factors.

As previously reported, severity of PAD by Rutherford classification was a predictor for major amputation in patients with PAD as in this study. A study on patients with chronic limb ischemia who underwent orbital atherectomy for endovascular treatment found the correlation between major amputation and Rutherford classification [24]. Those with Rutherford classification of 6 had lower amputation free lower than class 2–3 (88.6% vs 100%).

Total white blood cell count, an indicator for inflammation, has been reported to be associated with atherosclerosis and negative predictor of coronary artery diseases or stroke [25–27]. High blood cell count was associated with a 1-year mortality in patients who performed coronary artery bypass graft with adjusted hazard ratio of 1.6 times (95% confidence interval of 1.2–2.1) [25]. A study from Saudi Arabia also found an association between high white blood cell count and amputation [28]. Unfortunately, that study had a small sample size of 82 patients resulting in inability of performing multivariate logistic regression analysis. For a univariate logistic analysis, total white blood cell count showed significant unadjusted odds ratio for amputation with wide confidence interval due to small study population: unadjusted odds ratio of 383 with 95% confidence interval of 7.9–1,665. This study with a larger sample size found this association with narrow 95% confidence interval as shown in Table 3. Additionally, a meta-analysis also found a potential of white blood cell count and mortality and major vascular events: myocardial infarction or stroke in patients with PAD [29]. This meta-analysis found that high white blood cell count had odds ratio or hazard ratio for mortality in patients with PAD from 1.20–3.72. Note that settings in those studies were patients with PAD mostly with clinical limb ischemia or underwent endovascular surgery as in this study.

Serum albumin is anti-inflammatory, antioxidant, anticoagulant, and anti-platelet aggregation [30]. Several studies showed an association of low serum albumin and poor clinical outcome in coronary artery disease or heart failure [31–33]. Additionally, studies also showed that serum albumin was associated with clinical outcome such as amputation in patients with PAD who underwent endovascular surgery [34,35]. Another study found indirect evidence of the prognostic nutritional index (PNI), a combination of albumin and lymphocyte, was negatively associated with amputation in patients with PAD who were unsuitable for surgical intervention [36]. The adjusted odds ratio of the PNI was 0.905 which was little reduction risk of amputation compared with serum albumin alone in this study (adjusted odds ratio of 0.404 or almost 60% risk reduction). These results may indicate that serum albumin alone may be a better predictor for amputation. Additionally, patients with PAD should improve their nutritional status to have serum albumin of 2.7 g/dL to lower risk for future major amputation. Protein intake or nutritional supplement may increase serum albumin level [37,38]. A randomized controlled trial of 5 gm fish oil supplements in patients at ICU for two weeks significantly improved serum albumin from 3.05 to 3.69 gm/dL; p < 0.001 [38].

There are some limitations in this study. First, some factors may not be evaluated or studied such as obstructive sleep apnea and its related factors [39–45]. Second, patients with PAD in this setting are symptomatic only and 13.57% of patients reported classical claudication. Finally, some factors may be under-reported such as smoking or alcohol consumption.

4. Conclusions

Lower serum albumin was associated with higher major amputation risk in patients with symptomatic PAD.

Author contributions

S. Prasertcharoensuk – designed the study, collected data, contributed to methodology, resources, investigation, data validation, data interpretation, visualization, project administration and wrote the manuscript. K. Prateepphuangrat, P. Angkasith, P. Teeratakulpisarn, P. Tanmit, S. Chimluang – collected data, interpreted the data and reviewed the manuscript. K. Sawanyawisuth – performed the statistical analysis, interpreted the data, and reviewed the manuscript. N. Wongkonkitsin – designed the study, collected data, contriubuted to methodology, resources, investigation, data validation, data interpretation, visualization, project administration and revised the manuscript. S. Prasertcharoensuk and K. Sawanyawisuth – confirm the authenticity of all the raw data. All authors have read and approved the final manuscript.

Disclosure statement

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Ethical declaration

The study protocol was approved by the Ethics Committee of Human Research, Khon Kaen University, Thailand (HE621244).

References

Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers.

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