BackgroundSirolimus‐coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long‐term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de‐novo lesions from a real‐world practice.AimsTo report long‐term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions.Methods and ResultsWe analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high‐volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE).During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty‐two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST‐segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions (20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67).During the median follow‐up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure.ConclusionsThe results from this long‐term follow‐up in a real‐world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

中文翻译：

---

西罗莫司涂层球囊在新冠冠状动脉病变中的应用；来自多中心真实世界人群的长期临床结果


背景西罗莫司涂层球囊（SCB）是一种相对新颖的技术，由于其药物特性（安全性和有效性）而显得很有吸引力，并且西罗莫司仍然是支架的首选药物。然而，关于 SCB 的长期数据有限。在这项研究中，我们从现实世界的实践中探讨了在新发病变中使用 SCB 后的临床结果。目的报告在新发病变中使用西罗莫斯涂层球囊后的长期临床结果。方法和结果我们分析了2016 年至 2023 年间，在英国和意大利的四个大容量中心接受 SCB 治疗的所有新发病变患者。测量的结果包括心源性死亡、靶血管心肌梗死 (TVMI)、靶病变血运重建 (TLR) 和主要不良心脏事件 (MACE)。 在研究期间，771 名患者在新发病变中出现 SCB。 36% 的患者 (n = 280) 患有糖尿病，其中 14% (n = 108) 具有胰岛素依赖性。 15% (n = 117) 患有慢性肾病，52% (n = 398) 病例患有急性冠状动脉综合征 (ACS)，其中 51 例 (7%) 为 ST 段抬高型心肌梗死。小血管 (<3.0 mm) 占病例的 78% (n = 601)，76% (n = 584) 为长病变 (20 mm)。 SCB 的平均直径为 2.6 ± 0.4 mm，平均长度为 25 ± 10.39 mm。 9% 的病变需要在 SCB 后进行支架置入术（n = 67）。在中位随访 640 天期间，39 名患者（5%）发生完全死亡，其中 10 名患者（1.3%）发生心源性死亡。 20 名患者 (2.6%) 发生 TVMI。 TLR和TVR分别为5.6%和5.8%。总体 MACE 率为 8%。我们没有记录到急性血管闭塞的病例。结论 尽管患者群体复杂，但对现实世界人群的长期随访结果令人鼓舞，硬终点发生率较低，TLR 和 MACE 发生率可接受。我们的数据表明，SCB 在冠状动脉介入治疗中是安全的，从长远来看具有良好的临床结果。