Late clinical outcomes for SeQuent please paclitaxel-coated balloons in PCI of instent restenosis and de novo lesions : a single-center, real world registry

Objectives: The aims of this study were to evaluate clinical outcomes following PCI using SeQuent Please paclitaxel-coated balloons (PCB) of ISR and denovo lesions (DNL), in all-comer patients at Liverpool Hospital, Sydney, Australia. Background: There have been promising results for PCI using drug-coated balloons; however, long-term data for clinical outcomes are lacking. Methods: Baseline patient demographics, PCI procedural details, and clinical outcomes were collected. The primary endpoint was the incidence of MACE, a composite of cardiac death, myocardial infarction (MI), and clinical-driven target lesion restenosis (TLR). The median follow-up for clinical events was 1.3 [0.6-1.9] years. Results: A total of 188 lesions (n = 147 patients) were treated with PCB, comprising 118 (63%) ISR lesions and 70 (38%) DNL. Patient mean age was 67 ± 11years, 79% were male, and 54% had type 2 diabetes mellitus (DM). MACE was recorded in 17 patients (12%), with cardiac death confirmed in 1 patient (0.7%). MACE was significantly lower for DNL than ISR (1% vs. 15%, P = 0.03), and PCB had favourable TLR for DNL. Cox regression demonstrated that DM (HR 7.17, 0.92-55.6, P = 0.05) and prior CABG (HR 3.22, 1.17-8.83, P = 0.02) were independent predictors of MACE for ISR lesions. Conclusions: MACE rates were acceptable, with overall low incidence of cardiac death, MI, and TLR, for PCB treatment of ISR and DNL. Independent predictors of poor outcome in the ISR group were DM and prior CABG. The particularly low MACE for the DNL group supports direct PCB as a viable stent-sparing PCI strategy in challenging patients and lesion subsets.