Pantera Lux Drug-Coated Balloon for the Treatment of Coronary Artery Lesions in Routine Practice

<b>Background/Objectives:</b> We sought to confirm the performance and safety of the Pantera Lux paclitaxel-coated balloon (pDCB) when used as per the instructions for use at a single high-volume center. <b>Methods:</b> In this retrospective analysis, 386 consecutive patients were categorized into three groups: the treatment of drug-eluting stent in-stent restenosis (DES-ISR) lesions (n = 191), bare-metal stent in-stent restenosis (BMS-ISR) lesions (n = 127), and de novo lesions (n = 68). The primary endpoint at 12 months was target-lesion revascularization (TLR). Secondary endpoints were device success, target-vessel myocardial infarction (TV-MI), and cardiac death. <b>Results:</b> The baseline characteristics were balanced between the groups, with a median age of 71.3 years, 25% being female, 32% being diabetic. The majority presented with chronic coronary syndrome (82.9%). Type C lesions were more often observed in the DES-IRS group as compared with the BMS-IRS and de novo groups (15.6% vs. 7.9% vs. 7.4%, <i>p</i> < 0.001). Cutting balloons were more often used in the DES-IRS group (41.0% vs. 19.7% vs. 1.5%, <i>p</i> < 0.001). The residual stenosis rate was 7.6% vs. 3.3% vs. 7.3% (<i>p</i> = 0.002). The TLR at 12 months was 8.9% vs. 2.4% vs. 1.5% (<i>p</i> = 0.013). Device success was achieved in 98.8% vs. 98.5% vs. 100% of cases (<i>p</i> = 0.8). TV-MI occurred in 3.2% vs. 0.8% vs. 1.5% (<i>p</i> = 0.5) and cardiac death in 2.6% vs. 0.0% vs. 2.9% (<i>p</i> = 0.13) in DES-IRS vs. BMS-IRS vs. de novo lesions. <b>Conclusions:</b> In this single-center observation, we confirmed the safety and efficacy of the Pantera Lux paclitaxel-coated balloon for the treatment of DES-IRS, BMS-IRS, and de novo lesions with low TLR rates at 12 months.