Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland; DCB Academy, Milano, Italy.
Medical Clinic Number 1, "Iuliu Haţieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania.
Int J Cardiol. 2024 Nov 15;415:132436. doi: 10.1016/j.ijcard.2024.132436. Epub 2024 Aug 15.
Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in complex coronary artery disease (CAD) has been established as the standard of care, but stent-related events are not uncommon. Sirolimus-Coated Balloon (SCB)-based angioplasty is an emerging technology, although it needs to be thoroughly evaluated compared with DES in the complex PCI setting. This study aimed to investigate the safety and efficacy of SCB-based angioplasty compared with new-generation DES in complex PCI.
Net adverse cardiovascular events (NACE: all-cause death, target lesion revascularization, non-fatal myocardial infarction, and major bleedings according to BARC classification), as a primary study endpoint was compared between SCB and new-generation DES for complex coronary lesions.
Among 1782 patients with complex CAD, 1076 were treated with a sirolimus-coated balloon (EASTBOURNE Registry) and 706 with new-generation DES (COMPLEX Registry). After propensity score matching, a total of 512 patients in both groups were analyzed. NACE occurred more significantly in the DES group during the 1-year follow-up (10.5% vs. 3.9%, p = 0.003), mainly due to a higher risk of bleeding (6.6% vs. 0.4%, p = 0.001). The Cox model adjusted for lesion length showed a significantly lower hazard of NACE (HR: 0.23, CI [0.10, 0.52], p < 0.001) and all-cause mortality (HR: 0.07, CI [0.01, 0.66], p = 0.020) in SCB compared to DES group.
SCB angioplasty has an advantage over DES for the treatment of complex CAD regarding NACE, significantly reducing the incidence of major bleeding without increasing ischemic endpoints. SCB may be an alternative to DES in selected patients with complex coronary lesions.
药物洗脱支架（DES）经皮冠状动脉介入治疗（PCI）在复杂冠状动脉疾病（CAD）中已确立为标准治疗方法，但支架相关事件并不少见。载有西罗莫司的球囊（SCB）血管成形术是一种新兴技术，尽管与 DES 相比，它在复杂 PCI 环境中需要进行彻底评估。本研究旨在比较 SCB 血管成形术与新一代 DES 在复杂 PCI 中的安全性和疗效。
以全因死亡、靶病变血运重建、非致死性心肌梗死和 BARC 分类的主要出血等不良心血管事件（NACE）为主要研究终点，比较复杂冠状动脉病变患者中 SCB 与新一代 DES 的疗效。
在 1782 例复杂 CAD 患者中，1076 例接受载有西罗莫司的球囊（EASTBOURNE 注册研究）治疗，706 例接受新一代 DES（COMPLEX 注册研究）治疗。经倾向评分匹配后，两组各有 512 例患者进行分析。在 1 年随访期间，DES 组 NACE 发生率明显更高（10.5% vs. 3.9%，p=0.003），主要是由于出血风险较高（6.6% vs. 0.4%，p=0.001）。对病变长度进行校正的 Cox 模型显示，SCB 组 NACE（HR：0.23，CI[0.10，0.52]，p<0.001）和全因死亡率（HR：0.07，CI[0.01，0.66]，p=0.020）的风险显著降低。
与 DES 相比，SCB 血管成形术在治疗复杂 CAD 方面具有优势，可显著降低主要出血的发生率，而不增加缺血终点。在复杂冠状动脉病变的患者中，SCB 可能是 DES 的替代选择。
