Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
EuroIntervention. 2017 Aug 25;13(6):734-750. doi: 10.4244/EIJ-D-17-00499.
To overcome the limitations of metallic stents, the development of the bioresorbable vascular scaffold started about 30 years ago. Researchers anticipated a transformative revolution from "vascular reparative therapy" by BRS at the beginning of its development. To date, there are five commercially available bioresorbable scaffolds which have already gained CE mark. However, recent studies, including randomised trials and meta-analyses evaluating clinical results of BRS, have raised concerns about the safety and efficacy of the device in the first few years prior to its complete bioresorption, compared to contemporary metallic DES. As one of the efforts to address these concerns, the impact of implantation technique was investigated. In addition, there are several aspects to be improved such as mechanical integrity, strut configuration, and late structural discontinuity. Intensive researches into the underlying causes of the greater device thrombosis rates with BRS have stimulated improvement of implantation technique and the development of next-generation BRS. Just as we have witnessed the evolution from first- to second-generation metallic DES, we anticipate that future generations of BRS with thinner struts and enhanced mechanical properties will result in substantially improved intermediate-term outcomes and safety.
为了克服金属支架的局限性,大约 30 年前开始开发生物可吸收血管支架。研究人员在其开发之初就预期 BRS 将带来“血管修复治疗”的变革。迄今为止,已有 5 种市售的生物可吸收支架已获得 CE 标志。然而,最近的研究,包括随机试验和荟萃分析评估了 BRS 的临床结果,与同期金属 DES 相比,在其完全生物吸收之前的最初几年,对该设备的安全性和有效性提出了担忧。作为解决这些问题的努力之一,研究了植入技术的影响。此外,还有几个方面需要改进,例如机械完整性、支柱配置和晚期结构不连续性。对 BRS 更高的器械血栓形成率的潜在原因进行深入研究,促使改进了植入技术和开发了新一代 BRS。正如我们见证了第一代和第二代金属 DES 的发展,我们预计具有更薄支柱和增强机械性能的下一代 BRS 将带来显著改善的中期结果和安全性。