Mahtta Dhruv, Elgendy Islam Y
Department of Medicine, University of Florida, Gainesville, FL, USA.
Division of Cardiovascular Medicine, University of Florida, Gainesville, FL, USA -
Minerva Cardioangiol. 2019 Aug;67(4):288-305. doi: 10.23736/S0026-4725.19.04900-4. Epub 2019 Mar 18.
Bioresorbable vascular scaffolds (BVS) were developed to overcome the long-term limitations of metallic drug-eluting stents (DES). Shortcomings of DES include their permanent metallic cage which prevents normal coronary vasomotion, vascular remodeling, precludes future bypass grafting, and creates a nidus for very late stent thrombosis. With its transient scaffold which provides early mechanical support and subsequently resorbs thereby restoring physiologic properties and architecture of the vasculature, BVS offers a promising development within the field of interventional cardiology. Even though various BVS have been or are currently under development, the ABSORB BVS from Abbott Vascular was the first FDA approved device. In this review, we shed light on shortcomings of the current generation DES and theoretical advantages of BVS. In addition, we will discuss in detail clinical data from observational studies, meta-analyses, registries, and randomized controlled trials as it pertains to the efficacy and safety outcomes with everolimus-eluting BVS as compared to the current generation everolimus-eluting metallic stents (EES). We will summarize reasons behind the disappointing results from clinical trials and the failure of first generation BVS leading to its withdrawal from the market. Lastly, we will briefly review ongoing developments with the newer-generation BVS and future pre-clinical and clinical studies that are underway to evaluate the efficacy and safety of second-generation BVS.
生物可吸收血管支架(BVS)的研发旨在克服金属药物洗脱支架(DES)的长期局限性。DES的缺点包括其永久性金属支架,它会阻碍冠状动脉的正常运动、血管重塑,妨碍未来的搭桥手术,并为极晚期支架血栓形成创造病灶。BVS具有临时性支架,可提供早期机械支撑,随后吸收,从而恢复血管的生理特性和结构,在介入心脏病学领域提供了一个有前景的发展方向。尽管已经有多种BVS正在研发或已研发成功,但雅培血管公司的ABSORB BVS是首个获得美国食品药品监督管理局(FDA)批准的设备。在本综述中,我们阐述了当前一代DES的缺点以及BVS的理论优势。此外,我们将详细讨论观察性研究、荟萃分析、注册研究和随机对照试验的临床数据,这些数据涉及与当前一代依维莫司洗脱金属支架(EES)相比,依维莫司洗脱BVS的疗效和安全性结果。我们将总结临床试验结果令人失望以及第一代BVS失败并导致其退出市场的原因。最后,我们将简要回顾新一代BVS的持续发展情况以及正在进行的评估第二代BVS疗效和安全性的临床前和临床研究。