Lesion preparation as an independent determinant of outcomes after drug-coated balloon angioplasty: evidence from clinical, angiographic and functional assessment in observational cohort

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Abstract Background Coronary artery disease remains the leading cause of death and disability worldwide. Despite major technological progress in percutaneous coronary intervention (PCI), adverse events still occur - often related to the permanent presence of metal within the coronary arteries. In this context, drug-coated balloons (DCB) represent an important innovation, following the "leave-nothing-behind" approach, as they allow effective drug delivery without leaving a permanent implant. However, improvement in outcomes is determined not only by the procedural success, primarily driven by optimal lesion preparation, as well as by other clinical, anatomical, and procedural variables Purpose This study aims to investigate whether optimal angiographic lesion preparation independently predicted clinical outcomes after DCB angioplasty Methods We retrospectively analysed patients who underwent PCI with DCBs treatment, classifying treated lesions as optimal or non-optimal prepared based on pre-specified angiographic criteria: residual stenosis <30%, balloon-to-vessel ratio 1:1, TIMI flow grade >3, and absence of major dissection. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiovascular death, target lesion revascularization (TLR) and target lesion myocardial infarction (TL-MI). The median follow-up was 19 months. Secondary sub-analyses explored the prognostic role of quantitative flow ratio (QFR) and ΔQFR values Results Optimal lesion preparation was associated with a significantly lower hazard of target lesion failure (TLF) in Cox regression analysis (HR 0.30; 95% CI 0.12–0.74; p = 0.009). This association persisted after adjustment for significant predictors of TLF identified in logistic regression: in-stent restenosis HR = 0.36, p = 0.035; presence of moderate/severe calcification HR = 0.35, p = 0.031; previous revascularization HR = 0.31, p = 0.018; mean dcb diameter HR = 0.32, p = 0.020; use of cutting balloon HR = 0.32, p = 0.019; Diabetes mellitus HR = 0.33, p = 0.024 and use of non-compliant balloon HR = 0.31, p = 0.017. Kaplan–Meier analysis also showed significantly higher event-free survival at a median follow-up of 19 months in the optimally prepared group compared with non-optimally prepared lesions (94% vs. 84%; log-rank p = 0.005). The exploratory QFR analysis, in a subset of patients (n = 69), showed a trend toward higher post-procedural QFR values in lesions without TLF, suggesting a potential correlation. However, the association was not statistically significant (AUC < 0.5), likely due to limited sample size and low event rates Conclusion Optimal lesion preparation before DCB angioplasty was independently associated with a significant reduction in TLF during follow-up. These findings highlight the central role of lesion preparation in ensuring both procedural success and favourable long-term outcomes. Future investigations are warranted to identify other predictors of clinical outcomesTLF-free survival Kaplan-MeierFor image description, please refer to the figure legend and surrounding text. Forest Plot of Cox Regression ModelsFor image description, please refer to the figure legend and surrounding text.

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