Department of Cardiac, Interventional Cardiology, Sandro Pertini Hospital, Rome, Italy.
Department of Cardiac, Pantai Hospital Ayer Keroh, Melaka, Malaysia.
Catheter Cardiovasc Interv. 2024 Mar;103(4):532-538. doi: 10.1002/ccd.30996. Epub 2024 Feb 28.
Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited.
Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries.
We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling patients with a clinical indication to percutaneous coronary intervention performed by a sirolimus DCB according to investigator judgment. In the present analysis, a cut-off of 2.75 mm was used to define large coronary arteries. Primary endpoint of the study was clinically driven target lesion revascularization (TLR) at 24 months whereas secondary endpoint included procedural success, myocardial infarction (MI), cardiac death and total mortality.
Among the 2123 patients and 2440 lesions enrolled in the EASTBOURNE study between 2016 and 2020, 757 patients/810 lesions fulfilled the criteria for the present analysis. Mean reference vessel diameter was 3.2 ± 0.3 mm with mean lesion length of 22 ± 7 mm. Procedural success was high (96%) and at 2-year follow up the device showed a good efficacy with a TLR rate of 9%. There were 34 deaths (4.5%), 30 MIs (4%) and 8 BARC type 3-5 bleedings (1.1%). In-stent restenosis (629 lesions) and de novo lesions (181) were associated with 11% and 4% rates of TLR at 2 years, respectively (p = 0.003).
Clinical performance of a sirolimus DCB in large coronary artery vessels shows promising signals at 2-year follow up, both in de novo and in-stent restenosis lesions.
评估药物涂层球囊（DCB）治疗大冠状动脉病变的安全性和疗效的研究有限。
我们旨在评估西罗莫司 DCB 在大冠状动脉中的应用效果。
我们分析了 2016 年至 2020 年期间 EASTBOURNE 注册研究（NCT03085823）中所有符合经皮冠状动脉介入治疗适应证的患者，这些患者均由研究者判断使用西罗莫司 DCB 进行治疗。在本分析中，使用 2.75mm 的截止值来定义大冠状动脉。研究的主要终点是 24 个月时临床驱动的靶病变血运重建（TLR），次要终点包括手术成功率、心肌梗死（MI）、心脏死亡和全因死亡率。
在 2016 年至 2020 年期间 EASTBOURNE 研究中，共纳入 2123 例患者和 2440 处病变，其中 757 例患者/810 处病变符合本分析的标准。参考血管直径平均为 3.2±0.3mm，病变长度平均为 22±7mm。手术成功率高（96%），在 2 年随访时，该器械显示出良好的疗效，TLR 率为 9%。有 34 例死亡（4.5%）、30 例心肌梗死（4%）和 8 例 BARC 3-5 级出血（1.1%）。支架内再狭窄（629 处病变）和新发病变（181 处病变）的 TLR 率分别为 2 年时的 11%和 4%（p=0.003）。
西罗莫司 DCB 在大冠状动脉血管中的临床应用效果在 2 年随访时显示出良好的前景，无论是在新发病变还是支架内再狭窄病变中。
