Development and Internal Validation of a Bailout Risk Score in PCI with Drug-Coated Balloons

<b>Background/Objectives</b>: Bail-out stenting remains a procedural challenge for percutaneous coronary intervention (PCI) performed with drug-coated balloons (DCBs). No dedicated bedside tool is currently available to predict this event. We aimed to develop and internally validate a bedside Bail-Out Risk Score. <b>Methods</b>: We analyzed patients treated with DCBs between 2021 and 2025. Predictors of bailout stenting were identified through univariate analysis, and variables with <i>p</i> < 0.10 were entered into a multivariable logistic regression model. Regression coefficients were then transformed into integer points using the Sullivan method. Model performance was evaluated by AUC-ROC, calibration, and bootstrap internal validation (B = 1000). <b>Results</b>: A total of 352 patients (399 de novo lesions) were treated with DCB-only PCI. Bail-out stenting occurred in 14.5% of lesions (58/399). Independent predictors of bail-out stenting were prior CABG (OR 4.29, <i>p</i> = 0.002), proximal lesion location (OR 2.99, <i>p</i> = 0.003), and diffuse disease (OR 2.18, <i>p</i> = 0.018). Prior PCI (OR 0.44, <i>p</i> = 0.009) and lipid-lowering therapy (OR 0.42, <i>p</i> = 0.029) were protective, while LAD involvement showed a non-significant trend (OR 1.57, <i>p</i> = 0.137). The model demonstrated moderate discrimination (AUC = 0.734; optimism-corrected AUC = 0.704) and excellent calibration (intercept = 0.000, slope = 1.000). The final score (range -4 to +8) stratified lesions into low (≤-1), intermediate (0-3), and high (≥3) risk groups, with progressively higher predicted probabilities (≤9%, 13-37%, and ≥49%). <b>Conclusions</b>: The Bail-Out Risk Score provides a practical and reliable bedside tool to estimate procedural risk during stentless PCI.

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Journal
Journal of Clinical Medicine
Published
2026-01-19
DOI
https://doi.org/10.3390/jcm15020813
Primary Topic
Coronary Interventions and Diagnostics
Type
article
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article

Development and Internal Validation of a Bailout Risk Score in PCI with Drug-Coated Balloons

Giuseppe Ciliberti, Michele Franzese, Marco FERRONE, Luigi Salemme et al.
Journal of Clinical Medicine
Coronary Interventions and Diagnostics
article

Development and Internal Validation of a Bailout Risk Score in PCI with Drug-Coated Balloons

Giuseppe Ciliberti, Michele Franzese, Marco FERRONE, Luigi Salemme, Tullio Tesorio, Sebastiano Verdoliva, Armando Pucciarelli, Giulia Sgherzi, Giuseppe Di Gioia, Angelo Cioppa, Luigi Iossa, Elena Laganà, Grigore Popusoi
article en

Abstract

<b>Background/Objectives</b>: Bail-out stenting remains a procedural challenge for percutaneous coronary intervention (PCI) performed with drug-coated balloons (DCBs). No dedicated bedside tool is currently available to predict this event. We aimed to develop and internally validate a bedside Bail-Out Risk Score. <b>Methods</b>: We analyzed patients treated with DCBs between 2021 and 2025. Predictors of bailout stenting were identified through univariate analysis, and variables with <i>p</i> < 0.10 were entered into a multivariable logistic regression model. Regression coefficients were then transformed into integer points using the Sullivan method. Model performance was evaluated by AUC-ROC, calibration, and bootstrap internal validation (B = 1000). <b>Results</b>: A total of 352 patients (399 de novo lesions) were treated with DCB-only PCI. Bail-out stenting occurred in 14.5% of lesions (58/399). Independent predictors of bail-out stenting were prior CABG (OR 4.29, <i>p</i> = 0.002), proximal lesion location (OR 2.99, <i>p</i> = 0.003), and diffuse disease (OR 2.18, <i>p</i> = 0.018). Prior PCI (OR 0.44, <i>p</i> = 0.009) and lipid-lowering therapy (OR 0.42, <i>p</i> = 0.029) were protective, while LAD involvement showed a non-significant trend (OR 1.57, <i>p</i> = 0.137). The model demonstrated moderate discrimination (AUC = 0.734; optimism-corrected AUC = 0.704) and excellent calibration (intercept = 0.000, slope = 1.000). The final score (range -4 to +8) stratified lesions into low (≤-1), intermediate (0-3), and high (≥3) risk groups, with progressively higher predicted probabilities (≤9%, 13-37%, and ≥49%). <b>Conclusions</b>: The Bail-Out Risk Score provides a practical and reliable bedside tool to estimate procedural risk during stentless PCI.

Journal of Clinical MedicineVol. 15(2)
University of Verona (IT), Mercy Clinic Neurology (US), University of Naples Federico II (IT)
Reduced inequalities, Peace, Justice and strong institutions
Openalex Percentile: Top 84%
Coronary Interventions and Diagnostics
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