西罗莫司涂层球囊血管成形术治疗大型冠状动脉血管新生病变的疗效与安全性：一项倾向评分匹配研究
Efficacy and Safety of Sirolimus-Coated Balloon Angioplasty in De Novo Lesions in Large Coronary Vessels: A Propensity Score-Matched Study.
作者信息
Gobbi Cecilia, Giangiacomi Francesco, Pasero Guido, Faggiano Andrea, Barbieri Lucia, Tumminello Gabriele, Colombo Federico, Ruscica Massimiliano, Ardizzone Valentina, Genta Edoardo, Mircoli Luca, Galli Stefano, Carugo Stefano
机构信息
Department of Cardio-Thoracic-Vascular Diseases, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
出版信息
Catheter Cardiovasc Interv. 2025 Mar;105(4):861-869. doi: 10.1002/ccd.31402. Epub 2025 Jan 8.
BACKGROUND
Evidence regarding drug-coated balloon (DCB)-only angioplasty in de novo lesions of large vessels is still limited and mainly focused on paclitaxel-coated balloon. We aimed to analyze the safety and efficacy of sirolimus-coated balloon (SCB)-only angioplasty in de novo lesions in large vessels compared to drug-eluting stent (DES).
METHODS
In this retrospective, dual-center, case-control study, we enrolled all consecutive patients treated between January 2022 and January 2024 with SCB-only angioplasty in de novo lesion in large vessel (> 2.75 mm) compared to a propensity-score matched contemporary population treated with DES. The primary endpoint was the rate of target lesion revascularization (TLR), while secondary endpoints were cardiac death (CD), target vessel revascularization (TVR), myocardial infarction (MI), and target lesion failure (TLF), defined as a composite of them.
RESULTS
The mean age was 70.1 ± 9.8 years in the SCB group (n = 92) and 67.9 ± 9.6 years in the DES group (n = 92) (p = 0.76). The median follow-up was 19.5 ± 12 months in the SCB group and 20.1 ± 13.1 months in the DES group (p = 0.47). TLR occurred in 6.7% of patients in the SCB group and 5.6% in the DES group (p = 0.75). The incidence of MI, TVR, and TLF were similar between the two groups (4.3% vs 3.3%, p = 0.7, 2.2% vs 3.4%, p = 0.65% and 9.8% vs 8.7%, p = 0.79). CD occurred in 4.3% in the SCB group, compared to 3.3% in the DES group (p = 0.70).
CONCLUSION
Our study suggests that SCB angioplasty is both safe and effective in the treatment of de novo lesions of large vessels compared with DES.
背景
关于仅使用药物涂层球囊（DCB）治疗大血管初发病变的证据仍然有限，且主要集中在紫杉醇涂层球囊。我们旨在分析与药物洗脱支架（DES）相比，仅使用西罗莫司涂层球囊（SCB）治疗大血管初发病变的安全性和有效性。
方法
在这项回顾性、双中心、病例对照研究中，我们纳入了2022年1月至2024年1月期间所有连续接受仅使用SCB治疗大血管（>2.75mm）初发病变的患者，并与倾向评分匹配的同期接受DES治疗的人群进行比较。主要终点是靶病变血运重建（TLR）率，次要终点是心源性死亡（CD）、靶血管血运重建（TVR）、心肌梗死（MI）以及定义为它们组合的靶病变失败（TLF）。
结果
SCB组（n = 92）的平均年龄为70.1±9.8岁，DES组（n = 92）的平均年龄为67.9±9.6岁（p = 0.76）。SCB组的中位随访时间为19.5±12个月，DES组为20.1±13.1个月（p = 0.47）。SCB组6.7%的患者发生了TLR，DES组为5.6%（p = 0.75）。两组之间MI、TVR和TLF的发生率相似（4.3%对3.3%，p = 0.7；2.2%对3.4%，p = 0.65；9.8%对8.7%，p = 0.79）。SCB组4.3%的患者发生了CD，DES组为3.3%（p = 0.70）。
结论
我们的研究表明，与DES相比，SCB血管成形术治疗大血管初发病变既安全又有效。
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