Abstract:
Since the advent of coronary stents, two of the most common long-term complications after percutaneous coronary intervention (PCI) are in-stent restenosis (ISR) and stent thrombosis (ST). Although the rates of ST have been nearly abolished and ISR rates have declined with the current gold-standard second-generation drug-eluting stents (DES), late ISR of DES remains a valid concern in the field of interventional cardiology. The drug-coated balloon (DCB) is a non-stent technology that relies on the concept of targeted homogeneous drug delivery from an inflated balloon to restore luminal vascularity, treat atherosclerosis, and overcome some limitations of PCI, including ISR and prolonged dual antiplatelet therapy to prevent ST by leaving nothing behind. Most clinical evidence on coronary DCBs predominantly comes from small, randomized data and registries using paclitaxel DCBs for ISR and de novo lesions in the coronary space. Since 2014, outside the United States, DCBs have been approved for the treatment of ISR, with a class I recommendation by the European Society of Cardiology. The Food and Drug Administration very recently approved the Agent DCB to treat ISR in patients with coronary artery disease in the US. Additionally, recent randomized clinical data also showed DCB\'s safety and efficacy for the treatment of de novo small-vessel disease and high-bleeding-risk patients, while their role for other clinical situations including acute coronary syndrome, large-vessel disease, bifurcation lesions, and long-diffuse distal lesions is currently under investigation. Herein, we review the evidence-based role of DCBs in the treatment of coronary lesions and offer future perspectives.
摘要:
自从冠状动脉支架出现以来,经皮冠状动脉介入治疗(PCI)后最常见的两种长期并发症是支架内再狭窄(ISR)和支架内血栓形成(ST).尽管目前的黄金标准第二代药物洗脱支架(DES)几乎取消了ST的发生率,并且ISR的发生率有所下降,DES的晚期ISR仍然是介入心脏病学领域值得关注的问题.药物涂层球囊(DCB)是一种非支架技术,它依赖于从充气球囊进行靶向均匀药物递送以恢复管腔血管的概念,治疗动脉粥样硬化,并克服了PCI的一些局限性,包括ISR和延长的双联抗血小板治疗,通过不留下任何东西来预防ST.大多数关于冠状动脉DCB的临床证据主要来自小的,使用紫杉醇DCB治疗ISR和冠状动脉间隙从头病变的随机数据和注册表。自2014年以来,在美国以外,DCB已被批准用于治疗ISR,欧洲心脏病学会推荐的一级课程。美国食品和药物管理局最近批准DCB用于治疗美国冠状动脉疾病患者的ISR。此外,最近的随机临床数据也显示DCB的安全性和有效性,用于治疗从头小血管疾病和高出血风险患者,虽然它们对其他临床情况包括急性冠脉综合征的作用,大血管疾病,分叉病变,长弥漫性远端病变目前正在研究中。在这里,我们回顾了DCBs在冠状动脉病变治疗中的循证作用,并提出了未来的观点.