Tartaglia Francesco, Basavarajaiah Sandeep, Gitto Mauro, Cozzi Ottavia F, Knobel Leoni, Stutz Leah, Tran Quan, Loku Waduge Harindi, Leone Pier Pasquale, Calamita Gianmaria, Deepak Bhavnani Chandan, Maurina Matteo, Morosato Michele, Ielasi Alfonso, Gasparini Gabriele, Routledge Helen, Selvaraj Kamaraj, Testa Luca, Reimers Bernhard, Bossard Matthias, Cuculi Florim, Regazzoli Damiano, Stefanini Giulio G, Mangieri Antonio, Colombo Antonio
Department of Biomedical Sciences, Humanitas University, Milan, Italy.
IRCCS Humanitas Research Hospital, Milan, Italy.
Catheter Cardiovasc Interv. 2025 Nov;106(5):2958-2968. doi: 10.1002/ccd.70154. Epub 2025 Sep 5.
Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) on ostial left circumflex (oLCx) is associated with a high rate of adverse events.
This study aims to compare drug-coated balloons (DCB) and DES in the treatment of oLCx lesions.
Consecutive patients undergoing DCB-PCI of de novo oLCx lesions (isolated or in the context of a distal left main bifurcation) in eight international centers from 2018 to 2023 were retrospectively enrolled and compared with a historical cohort of patients who received PCI with DES. 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. Propensity-score matching was adopted to adjust for clinical and angiographic confounders.
A total of 152 patients were included in the DCB group and 351 patients in the DES group. Patients in the DES group had more multivessel disease (94.6% vs. 82.7%, p < 0.001) but shorter lesions (18.0 [interquartile range, IQR: 15.0-28.0] vs. 25.5 [17.4-40.0] mm, p < 0.001) than those in the DCB group. Fluoroscopy time (20.0 [IQR: 14.0-28.2] vs. 31.0 [21.0-45.5] min, p < 0.001) and amount of contrast used (150 [IQR: 120-220] vs. 200 [140-250] mL, p = 0.006) were significantly lower in DCB-PCI than DES-PCI. The 2-year rate of TLF was similar in the two groups (19.0% in the DCB group vs. 19.8% in the DES group, hazard ratio [HR]: 1.05, 95% confidence interval [CI] 0.64-1.75). This result remained consistent in the 126 pairs of patients obtained after propensity score matching.
In a multinational observational retrospective real-world study including patients undergoing PCI on oLCx, no difference in TLF rate was detected between PCI with DCB and PCI with DES at a midterm follow-up.
在左回旋支开口处（oLCx）使用药物洗脱支架（DES）进行经皮冠状动脉介入治疗（PCI）与高不良事件发生率相关。
本研究旨在比较药物涂层球囊（DCB）和DES治疗oLCx病变的效果。
回顾性纳入2018年至2023年在8个国际中心接受DCB-PCI治疗新发oLCx病变（孤立病变或在左主干远端分叉情况下）的连续患者，并与接受DES-PCI的历史队列患者进行比较。主要终点是在首次事件分析时，目标病变失败（TLF）的2年发生率，其为目标病变血运重建（TLR）、目标血管心肌梗死和心源性死亡的复合终点。采用倾向评分匹配来调整临床和血管造影混杂因素。
DCB组共纳入152例患者，DES组共纳入351例患者。DES组患者多支血管病变更多（94.6%对82.7%，p<0.001），但病变长度短于DCB组（18.0[四分位数间距，IQR：15.0 - 28.0]对25.5[17.4 - 40.0]mm，p<0.001）。DCB-PCI的透视时间（20.0[IQR：14.0 - 28.2]对31.0[21.0 - 45.5]分钟，p<0.001）和造影剂用量（150[IQR：120 - 220]对200[140 - 250]mL，p = 0.006）显著低于DES-PCI。两组的2年TLF发生率相似（DCB组为19.0%，DES组为19.8%，风险比[HR]：1.05，95%置信区间[CI]0.64 - 1.75）。在倾向评分匹配后获得的126对患者中，这一结果保持一致。
在一项纳入接受oLCx-PCI患者的跨国观察性回顾性真实世界研究中，中期随访时DCB-PCI和DES-PCI的TLF率未检测到差异。
