Farhan Muhammad, Hasan Gadeer, Sobhi Abdulaziz, Yasser Karim, Humam Mohamad, Ali Mustafa, Younes Sara, Nazir Muhammad Hashir, Mateen Mohammed Abdul, Misra Gayatri, Patel Tirath
Department of Internal Medicine, Ajman University, College of Medicine, Ajman, United Arab Emirates.
Department of Internal Medicine, University of Sharjah, College of Medicine, Sharjah, United Arab Emirates.
Ann Med Surg (Lond). 2025 Apr 22;87(7):4173-4183. doi: 10.1097/MS9.0000000000003424. eCollection 2025 Jul.
Over the past few decades, researchers have attempted to overcome the disadvantages of metallic stents. This led to the birth of the first "Bioresorbable Scaffold" (BRS) model, the Absorb Bioresorbable Vascular Scaffold (BVS), in 1999 by Abbott. A stent that spontaneously resorbs shows a promising theoretical minimal risk of long-term stent thrombosis and omits the need for long-term antiplatelet therapy. However, only one year after its Food and Drug Administration (FDA) approval in 2016, it was voluntarily withdrawn owing to concerns regarding its safety because of the higher risk of target lesion failure. Although long-term follow-up data from the ABSORB IV trial were released in 2023 and showed a comparable long-term safety profile for BRS compared to conventional metallic stents, with only a slightly higher target lesion failure in the first three years, concerns remain regarding their use. Therefore, in this study, we discuss the different adverse events associated with different BRS models. We also discuss various approaches to optimizing the use of BRS, new BRS manufacturing techniques (e.g., 3D printing), and novel BRS models yet to be approved (e.g., DREAM 3G magnesium-based BRS). We suggest carefully selecting patients who could obtain the maximum benefit from BRS through the discussed selection criteria, which could reduce the risk of target lesion failure and BRS complications. Using newer technologies, such as 3D printing, also has excellent potential for making BRS more cost- and market-friendly, owing to their fast output and ability to form individually curated scaffolds.
在过去几十年里,研究人员一直在尝试克服金属支架的缺点。这促成了首个“生物可吸收支架”(BRS)模型——雅培公司的Absorb生物可吸收血管支架(BVS)于1999年诞生。一种能自发吸收的支架在理论上显示出长期支架血栓形成风险极小的前景,并且无需长期抗血小板治疗。然而,在2016年获得美国食品药品监督管理局(FDA)批准仅一年后,由于担心其安全性,特别是鉴于靶病变失败风险较高,它被主动撤回。尽管2023年公布了ABSORB IV试验的长期随访数据,显示与传统金属支架相比,BRS的长期安全性相当,只是在头三年靶病变失败率略高,但对于其使用仍存在担忧。因此,在本研究中,我们讨论了与不同BRS模型相关的不同不良事件。我们还讨论了优化BRS使用的各种方法、新的BRS制造技术(如3D打印)以及尚未获批的新型BRS模型(如DREAM 3G镁基BRS)。我们建议通过所讨论的选择标准仔细挑选能够从BRS中获得最大益处的患者,这可以降低靶病变失败和BRS并发症的风险。使用诸如3D打印等新技术,由于其产出速度快且能够制造个性化定制的支架,在使BRS更具成本效益和市场亲和力方面也具有巨大潜力。