Procedural complexity during percutaneous coronary interventions (PCI) with drug-eluting stent (DES) has been associated with adverse events, especially in case of long and multiple stents implantation. This study aims to validate contemporary complex PCI criteria for drug coated balloon (DCB)-based PCI. Consecutive patients undergoing DCB angioplasty at 2 Italian centers from 2018 to 2023 were retrospectively enrolled. Complex DCB-PCI was defined as the presence of at least 1 of the 6 following features: 3 vessels treated; ≥ 3 lesions treated; ≥ 3 devices (DES or DCB) used; bifurcation treated with 2 devices; total device length (DES + DCB) > 60 mm; CTO as target lesion. The primary endpoint was the 2 year incidence of target lesion failure (TLF), a composite of target lesion revascularization (TLR), target vessel-myocardial infarction and cardiac death, at time-to-first event analysis. A total of 1279 patients were included, of whom 642 (50.2
Drug-coated balloons (DCBs) are increasingly used to treat coronary artery disease, and their safety and efficacy profile can vary based on the eluted drug and excipient. Head-to-head comparisons of paclitaxel-coated balloons (PCBs) according to contemporary excipient formulations are scant. Consecutive patients undergoing DCB angioplasty with either urea PCB (Prevail, Medtronic, Dublin, Ireland) or iopromide PCB (Sequent Please / NEO, B. Braun, Melsungen, Germany) at two Italian institutions from 2021 to 2024 were retrospectively enrolled. The primary endpoint was target lesion failure (TLF), a composite including target lesion revascularization, target vessel myocardial infarction, and cardiac death, at 1 year. Clinical endpoints were compared through propensity score adjustment for clinical and angiographic variables. A total of 448 patients were included, with 211 patients (240 lesions) treated with urea PCB and 237 patients (287 lesions) treated with iopromide PCB. The prevalence of in-stent restenosis (ISR) was 30
BACKGROUND:The third-generation Fantom Encore bioresorbable scaffold (BRS), made with Tyrocore polymer, features full radiopacity, 95-115 μm strut thickness, and high expansion capacity. Currently, there is a lack of real-world data on this device. METHODS AND RESULTS:We conducted a retrospective, single-center study involving 28 elective patients undergoing percutaneous coronary intervention (PCI) for 43 de novo coronary lesions with implantation of the Fantom Encore BRS. Mean age was 66.6 ± 8.5 years (male 82.1 %). Number of target lesions/patient was 1.54 ± 0.99, and 89.3 % of patients had single-vessel disease; most lesions were type C (58.1 %). Number of BRS/lesion was 1.02 ± 0.15, with a mean maximum scaffold diameter/lesion of 3.39 ± 0.41 mm and a mean scaffold length/lesion of 24.8 ± 8.17 mm. Plaque debulking was necessary in 32.6 % of lesions and IVUS was employed in 74.4 % of lesions. Acute technical success was achieved in 97.7 % of cases. Clinical follow-up was available in 96.4 % of cases. At a median of 18 months (range: 9-31 months) no patient experienced major adverse cardiovascular events (MACE); notably, no scaffold thrombosis was reported. Angiographic follow-up was performed in 50 % of patients at a median of 17 months (range: 6-35), with no documented cases of target lesion failure. CONCLUSION:Fantom Encore BRS shows good potential in delivering safe and effective PCI outcomes in patients with stable coronary artery disease, including those with complex coronary lesions.
Coronary dissection is a potential occurrence after lesion preparation for percutaneous coronary intervention (PCI). Unlike stents, drug-coated balloons (DCBs) do not allow to cover dissections, thus demanding an assessment of their safety in this setting. This study aimed to evaluate the incidence, predictors, and clinical outcomes of dissections occurring with DCB-based PCI for de novo coronary artery disease. Consecutive patients with de novo coronary artery disease who underwent PCI with intention-to-treat DCB angioplasty, with or without stent implantation, were retrospectively enrolled between 2018 and 2022 at 2 Italian centers. The decision whether to leave a dissection untreated or to proceed with bail-out stenting was based on a combined angiographic evaluation of Thrombolysis In Myocardial Infarction flow, residual minimal lumen diameter, and persistent extraluminal contrast hang-up. The primary end point at 2-year follow-up was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization. Among 522 DCB-treated lesions (466 patients), dissections were angiographically evident in 39.1% of cases, with 21.1% which underwent bail-out stenting and 78.9% left untreated. The incidence of bail-out stenting increased from type A to type E dissections (p for trend <0.001). Left anterior descending artery involvement (odds ratio 1.64, 95% confidence interval 1.12 to 2.39) was the strongest risk factors for dissection. Target lesion failure at 2 years occurred in 2.7% of lesions with untreated dissection compared with 4.2% of those with no dissection (log-rank p = 0.324). In conclusion, coronary dissections often complicate PCI with DCB angioplasty but do not correlate with increased risk of adverse events at midterm follow-up.
