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

Area of Science:

• Interventional Cardiology
• Medical Device Technology
• Clinical Risk Prediction

Background:

• Bail-out stenting is a significant challenge in percutaneous coronary intervention (PCI) using drug-coated balloons (DCBs).
• Currently, no bedside tool exists to predict the likelihood of requiring bail-out stenting during DCB procedures.
• This gap highlights the need for a practical method to assess procedural risk.

Purpose of the Study:

• To develop and internally validate a bedside risk score for predicting bail-out stenting in DCB-treated lesions.
• To identify independent predictors of bail-out stenting in patients undergoing DCB-only PCI.
• To provide a tool for real-time risk assessment during complex PCI procedures.

Main Methods:

• Analysis of 352 patients (399 lesions) treated with DCB-only PCI between 2021-2025.
• Multivariable logistic regression identified predictors of bail-out stenting, with significant variables converted to integer points.
• Model performance assessed using AUC-ROC, calibration, and bootstrap internal validation.

Main Results:

• Bail-out stenting occurred in 14.5% of lesions.
• Independent predictors included prior CABG, proximal lesion location, and diffuse disease; prior PCI and lipid-lowering therapy were protective.
• The developed Bail-Out Risk Score demonstrated moderate discrimination (AUC=0.734) and excellent calibration, stratifying patients into low, intermediate, and high-risk groups.

Conclusions:

• The Bail-Out Risk Score is a practical and reliable bedside tool for estimating procedural risk in stentless PCI.
• The score aids clinicians in anticipating and managing potential complications during DCB procedures.
• This tool can potentially improve patient outcomes by enabling better procedural planning and risk stratification.