Gobbi Cecilia, Giangiacomi Francesco, Merinopoulos Ioannis, Gherbesi Elisa, Faggiano Andrea, Pasero Guido, Barbieri Lucia, Tumminello Gabriele, Colombo Federico, Mircoli Luca, Ruscica Massimiliano, Vassiliou Vassilios S, Eccleshall Simon C, Carugo Stefano
Department of Cardio-Thoracic-Vascular Diseases, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122, Milan, Italy.
Department of Clinical Sciences and Community Health, University of Milan, 20122, Milan, Italy.
Sci Rep. 2025 Feb 10;15(1):4921. doi: 10.1038/s41598-025-85734-4.
We aimed to investigate the safety of drug-coated balloon (DCB)-only percutaneous coronary intervention compared to drug-eluting stent (DES) for de novo lesions in large vessels. To pursue this goal, we conducted a systematic review and meta-analysis following the PRISMA guidelines. The analysis included studies that utilized DCB-only or hybrid angioplasty for de novo lesions in large coronary vessel (> 2.75 mm). The primary outcome was to assess the target lesion revascularization (TLR) rate, while secondary outcomes included cardiac death, myocardial infarction (MI), and the composite of these. A total of 15 studies, comprising 3975 patients (of whom 2114 treated with DCB) were included. Median age was 62 ± 1.5 years, with 77.4% being male. Overall, 26.9% had diabetes, and 67.6% were diagnosed with acute coronary syndrome. Over a pooled follow-up of 20.6 ± 1.9 months, the incidence of TLR was 4% in the pooled DBC group. Additionally, over a pooled follow-up of 25.8 ± 2.7 months, no significant differences were observed in incidence of TLR between the DCB group and the DES group (4.3% vs. 6.9%, odds ratio 0.71, 95% confidence interval 0.50-1.01, p = 0.059). Furthermore, there were no differences in incidence of cardiac death and MI. DCB angioplasty treatment of de novo lesions in large coronary vessels could be a safe and effective strategy in both acute and chronic coronary settings. The incidence of target lesion revascularization appears to be similar to that of contemporary DES.
我们旨在研究单纯药物涂层球囊（DCB）经皮冠状动脉介入治疗与药物洗脱支架（DES）治疗大血管新发病变的安全性。为实现这一目标，我们按照PRISMA指南进行了系统评价和荟萃分析。该分析纳入了对大冠状动脉血管（>2.75mm）新发病变采用单纯DCB或混合血管成形术的研究。主要结局是评估靶病变血运重建（TLR）率，次要结局包括心源性死亡、心肌梗死（MI）以及两者的复合结局。共纳入15项研究，包括3975例患者（其中2114例接受DCB治疗）。中位年龄为62±1.5岁，男性占77.４%。总体而言，26.9%患有糖尿病，67.6%被诊断为急性冠状动脉综合征。在汇总随访20.6±1.9个月时，汇总DCB组的TLR发生率为4%。此外，在汇总随访25,8±2.7个月时，DCB组和DES组之间的TLR发生率无显著差异（4.3%对6.9%，优势比0.71，95%置信区间0.50-1.01，p=0.059）。此外，心源性死亡和MI的发生率也无差异。在急性和慢性冠状动脉疾病情况下，采用DCB血管成形术治疗大冠状动脉血管新发病变可能是一种安全有效的策略。靶病变血运重建的发生率似乎与当代DES相似。
