Background <p>Drug-coated balloon (DCB) represents a valid alternative to drug-eluting stents for the treatment of de novo coronary lesions. However, procedural results are routinely limited to a subjective visual estimation of residual stenosis and dissection grade. Invasive quantitative predictors of long-term outcomes, such as functional assessment or intravascular imaging remain underutilized in the real world. New computational angiography-derived analyses offer a valuable alternative, providing integrated anatomical, functional, and biomechanical information. We aim to evaluate the predictive value of percent diameter stenosis (%DS), Murray’s law-based flow ratio (μFR), and maximum radial wall strain (RWS<sub>max</sub>).</p> Methods <p>De novo lesions treated with DCB-only strategy were retrospectively analyzed. Clinical outcome was MACEs, including target vessel revascularization, myocardial infarction, and all-cause death. Receiver operating characteristic curves identified the best predictors among baseline, post-predilation, post-DCB, and delta values of %DS, μFR, and RWS<sub>max</sub>. The Youden index was used to determine the optimal cut-off value for dichotomizing the population in the survival analyses. A propensity score (PS) was estimated using multivariable logistic regression including the main clinical parameters, and included as a continuous covariate in the Cox proportional hazards model to adjust for confounding.</p> Results <p>A total of 264 lesions were included. Over a median follow-up of 10 (7, 18) months, 21 MACEs were recorded. Post-DCB %DS and μFR, and post-predilation RWS<sub>max</sub> were selected as MACE predictors by ROC analyses. MACE-free survival differed significantly for μFR ≤ 0.90 vs &gt; 0.90 (log-rank = 0.007, HR = 3.06, 95% CI: 1.30–7.21). These findings remained significant after adjusting for confounders (HR = 4.40, 95% CI: 1.51–12.80). A higher risk of MACEs was observed for post-DCB %DS ≥ 27% vs &lt; 27% (HR = 2.75, 95% CI: 1.16–6.52), but this association lost significance after adjustment for confounders (HR = 2.03, 95% CI: 0.77–5.39). No significant difference was observed for post-predilation RWS<sub>max</sub> ≥ 21.3% vs &lt; 21.3%.</p> Conclusion <p>Final μFR was an independent predictor of outcomes after DCB treatment. Post-DCB %DS had limited predictive value when adjusted for confounders. RWS<sub>max</sub> showed no significant predictive value; its potential relevance warrants further investigation, particularly in drug-specific subgroups.</p>

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Comparative prognostic value of diameter stenosis, Murray law-based quantitative flow ratio and radial wall strain after drug-coated balloon in de novo coronary lesions

  • Edoardo O. Genta,
  • Ettore Ventura,
  • Enrico Canese,
  • Stefano De Martini,
  • Bianca A. Magnanini,
  • Matteo Ferrari,
  • Chiara Morocutti,
  • Alice Bonomi,
  • Piero Montorsi,
  • Stefano Galli

摘要

Background

Drug-coated balloon (DCB) represents a valid alternative to drug-eluting stents for the treatment of de novo coronary lesions. However, procedural results are routinely limited to a subjective visual estimation of residual stenosis and dissection grade. Invasive quantitative predictors of long-term outcomes, such as functional assessment or intravascular imaging remain underutilized in the real world. New computational angiography-derived analyses offer a valuable alternative, providing integrated anatomical, functional, and biomechanical information. We aim to evaluate the predictive value of percent diameter stenosis (%DS), Murray’s law-based flow ratio (μFR), and maximum radial wall strain (RWSmax).

Methods

De novo lesions treated with DCB-only strategy were retrospectively analyzed. Clinical outcome was MACEs, including target vessel revascularization, myocardial infarction, and all-cause death. Receiver operating characteristic curves identified the best predictors among baseline, post-predilation, post-DCB, and delta values of %DS, μFR, and RWSmax. The Youden index was used to determine the optimal cut-off value for dichotomizing the population in the survival analyses. A propensity score (PS) was estimated using multivariable logistic regression including the main clinical parameters, and included as a continuous covariate in the Cox proportional hazards model to adjust for confounding.

Results

A total of 264 lesions were included. Over a median follow-up of 10 (7, 18) months, 21 MACEs were recorded. Post-DCB %DS and μFR, and post-predilation RWSmax were selected as MACE predictors by ROC analyses. MACE-free survival differed significantly for μFR ≤ 0.90 vs > 0.90 (log-rank = 0.007, HR = 3.06, 95% CI: 1.30–7.21). These findings remained significant after adjusting for confounders (HR = 4.40, 95% CI: 1.51–12.80). A higher risk of MACEs was observed for post-DCB %DS ≥ 27% vs < 27% (HR = 2.75, 95% CI: 1.16–6.52), but this association lost significance after adjustment for confounders (HR = 2.03, 95% CI: 0.77–5.39). No significant difference was observed for post-predilation RWSmax ≥ 21.3% vs < 21.3%.

Conclusion

Final μFR was an independent predictor of outcomes after DCB treatment. Post-DCB %DS had limited predictive value when adjusted for confounders. RWSmax showed no significant predictive value; its potential relevance warrants further investigation, particularly in drug-specific subgroups.