Tartaglia Francesco, Gitto Mauro, Leone Pier Pasquale, Chiarito Mauro, Calamita Gianmaria, Mincione Gianluca, Gasparini Gabriele, Reimers Bernhard, Cozzi Ottavia F, Rossi Marco L, Stefanini Giulio G, Regazzoli Damiano, Mangieri Antonio, Colombo Antonio
Department of Biomedical Sciences, Humanitas University, 20072, Pieve Emanuele, Milan, Italy.
Department of Cardiovascular Medicine, IRCCS Humanitas Research Hospital, 20089, Rozzano, Milan, Italy.
Clin Res Cardiol. 2025 May 19. doi: 10.1007/s00392-025-02664-x.
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%) met complex PCI criteria. The most frequently met criteria was "total device length > 60 mm" (71.6% in the complex PCI group). The proportion of in-stent restenosis (ISR) was 30.8% in the complex DCB-PCI group and 43.8% in the non-complex PCI group (p < 0.001). After adjusting for relevant clinical covariates and for the presence of ISR, patients undergoing complex PCI had a higher incidence of TLF at 2 years as compared to those undergoing non-complex PCI (16.7 vs. 11.4%; adj. hazard ratio 1.73, 95% confidence interval 1.16-2.59, p = 0.007). However, such difference was significant only in the ISR subgroup, while outcomes of complex and non-complex PCI for de novo lesions were similar.
In a real-world cohort of patients undergoing DCB angioplasty, complex PCI criteria were frequently met and associated with higher risk of TLF. However, their prognostic impact was limited in patients with de novo coronary lesions treated with DCB.
药物洗脱支架（DES）经皮冠状动脉介入治疗（PCI）过程中的操作复杂性与不良事件相关，尤其是在植入长支架和多个支架的情况下。
本研究旨在验证基于药物涂层球囊（DCB）的PCI的当代复杂PCI标准。
回顾性纳入2018年至2023年在2家意大利中心接受DCB血管成形术的连续患者。复杂DCB-PCI定义为存在以下6项特征中的至少1项：治疗3支血管；治疗≥3处病变；使用≥3个器械（DES或DCB）；用2个器械治疗分叉病变；总器械长度（DES+DCB）>60mm；将慢性完全闭塞病变（CTO）作为靶病变。主要终点是在首次事件分析时2年靶病变失败（TLF）的发生率，TLF是靶病变血运重建（TLR）、靶血管心肌梗死和心源性死亡的复合终点。
共纳入1279例患者，其中642例（50.2%）符合复杂PCI标准。最常符合的标准是“总器械长度>60mm”（复杂PCI组中占71.6%）。复杂DCB-PCI组的支架内再狭窄（ISR）比例为30.8%，非复杂PCI组为43.8%（p<0.001）。在调整相关临床协变量和ISR的存在后，与接受非复杂PCI的患者相比，接受复杂PCI的患者在2年时TLF的发生率更高（16.7%对11.4%；调整后风险比1.73，95%置信区间1.16-2.59，p=0.007）。然而，这种差异仅在ISR亚组中显著，而DCB治疗初发病变的复杂PCI和非复杂PCI的结果相似。
在接受DCB血管成形术的真实世界患者队列中，经常符合复杂PCI标准且与较高的TLF风险相关。然而，它们对接受DCB治疗的初发冠状动脉病变患者的预后影响有限。
