Abstract Body (Do not enter title and authors here): Background: Paclitaxel-coated balloon (PCB) has been used for the treatment of coronary artery disease in the small native coronary artery and its safety and efficacy have been reported in clinical trials.
Research Questions: The real-word long-term outcomes after intravascular imaging device-guided percutaneous coronary intervention (PCI) with PCB have not fully elucidated.
Aims: To elucidate the long-term outcome after PCB treatment.
Methods: This was a single-center, retrospective and observational study. We enrolled 1226 lesions from 713 patients which were treated by intravascular imaging device-guided PCI with PCB (342 lesions from 211 patients) or durable-polymer everolimus-eluting stent (DP-EES, 784 lesions from 502 patients) which diameter was less than 3.0 mm in the native coronary arteries. Long-term clinical outcomes were compared between PCB and DP-EES. Primary outcome was major adverse cardiac event (MACE) defined as a composite of cardiac death (CD), myocardial infarction (MI), target vessel revascularization (TVR) and device thrombosis. Secondary outcomes were all-cause death, CD, MI, target lesion revascularization (TLR), TVR and device thrombosis. Cumulative incidences of clinical outcomes were estimated by the Kaplan-Meier method and compared by the log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) of PCB relative to DP-EES for MACE were estimated through a multivariable Cox model and an inverse probability weighted (IPW).
Results: Cumulative 5-year incidence of MACE was similar between PCB and DP-EES (18.5% vs. 20.7%, P=0.78, Figure). Cumulative 5-year incidences of all-cause death (23.2% vs. 16.8%, P=0.12), CD (8.0% vs. 7.0%, P=0.81), MI (2.2% vs. 2.5%, P=0.97), TLR (5.9% vs. 8.9%, P=0.35), TVR (12.6% vs. 14.4%, P=0.90) and device thrombosis (0% vs. 0.6%, P=0.20) were also similar between PCB and DP-EES. Even after adjustment for baseline characteristics, cumulative 5-year incidence of MACE was similar between PCB and DP-EES (multivariate and IPW adjusted HRs 0.72 [95% CI: 0.37-1.39], P=0.33 and 0.67 [95% CI: 0.21-2.07], P=0.48, respectively).
Conclusion: PCB demonstrated comparable 5-year clinical outcomes with intravascular imaging device-guided PCI compared to DP-EES.