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Updated: Jan 18, 2026
Predicting Amputation using Local Circulating Mononuclear Progenitor Cells in Angioplasty-treated Patients with Critical Limb Ischemia
Published on: September 22, 2020
Validation of randomized controlled trial-derived models for the prediction of postintervention outcomes in chronic
Joep G J Wijnand1, Ian D van Koeverden2, Martin Teraa1
1Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands; Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Insights
Predictive models for chronic limb-threatening ischemia (CLTI) showed fair performance in predicting outcomes. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) model demonstrated the best predictive value for amputation-free survival in CLTI patients.
Area of Science:
- Vascular Surgery
- Cardiovascular Medicine
- Biostatistics
Background:
- Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, significantly impacting patient quality of life, morbidity, and mortality.
- Interventions for CLTI aim to improve tissue perfusion, prevent amputations, and reduce cardiovascular complications, necessitating accurate risk-benefit assessments.
- Existing prediction models for CLTI outcomes, developed from randomized controlled trials, aim to enhance clinical decision-making.
Purpose of the Study:
- To evaluate the performance of established prediction models in forecasting clinical outcomes within selected CLTI patient cohorts.
- To assess the accuracy of the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL), Finland National Vascular registry (FINNVASC), and Prevention of Infrainguinal Vein Graft Failure (PREVENT III) models.
Main Methods:
- Validation of prediction models using data from the Athero-Express peripheral artery disease registry and two randomized controlled trials (JUVENTAS and PADI).
- Application of Receiver Operating Characteristic (ROC) curve analysis to determine the predictive capacity of each model.
- Primary outcome: amputation-free survival (AFS); secondary outcomes: all-cause mortality and amputation at 12 months post-intervention.
Main Results:
- The BASIL and PREVENT III models showed moderate predictive value for post-intervention mortality in the JUVENTAS cohort (AUC 81% and 70%).
- Prediction of AFS was generally poor to fair across all models and populations (AUC 0.60-0.71), with BASIL showing the highest value (71%) in the JUVENTAS population.
- The FINNVASC model demonstrated the highest predictive value for amputation risk in the PADI population (AUC 78% at 12 months).
Conclusions:
- Existing prediction models generally exhibit poor to fair performance in predicting mortality and amputation in CLTI patients.
- The BASIL model showed the best performance for predicting AFS and is proposed to aid clinical decision-making in CLTI.
- Significant improvements are required for these models to provide substantial additional value in routine clinical practice.
Background:
Chronic limb-threatening ischemia (CLTI) represents the most severe form of peripheral artery disease and has a large impact on quality of life, morbidity, and mortality. Interventions are aimed at improving tissue perfusion and averting amputation and secondary cardiovascular complications with an optimal risk-benefit ratio. Several prediction models regarding postprocedural outcomes in CLTI patients have been developed on the basis of randomized controlled trials to improve clinical decision-making. We aimed to determine model performance in predicting clinical outcomes in selected CLTI cohorts.
Methods:
This study validated the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL), Finland National Vascular registry (FINNVASC), and Prevention of Infrainguinal Vein Graft Failure (PREVENT III) models in data sets from a peripheral artery disease registry study (Athero-Express) and two randomized controlled trials of CLTI in The Netherlands, Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-arterial Supplementation (JUVENTAS) and Percutaneous Transluminal Angioplasty and Drug-eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI). Receiver operating characteristic (ROC) curve analysis was used to calculate their predictive capacity. The primary outcome was amputation-free survival (AFS); secondary outcomes were all-cause mortality and amputation at 12 months after intervention.
Results:
The BASIL and PREVENT III models showed predictive values regarding postintervention mortality in the JUVENTAS cohort with an area under the ROC curve (AUC) of 81% and 70%, respectively. Prediction of AFS was poor to fair (AUC, 0.60-0.71) for all models in each population, with the highest predictive value of 71% for the BASIL model in the JUVENTAS population. The FINNVASC model showed the highest predictive value regarding amputation risk in the PADI population with AUC of 78% at 12 months.
Conclusions:
In general, all models performed poor to fair in predicting mortality and amputation. Because the BASIL model performed best in predicting AFS, we propose use of the BASIL model to aid in the clinical decision-making process in CLTI. However, improvements in performance have to be made for any of these models to be of real additional value in clinical practice.
