Abizaid Alexandre, Ribamar Costa J
Instituto Dante Pazzanese de Cardiologia, Av. Dr. Dante Pazzanese, 500 - Vila Mariana, São Paulo, SP, Brazil, CEP 04012-180.
Hospital do Coração, São Paulo, SP, Brazil.
Curr Cardiol Rep. 2017 Mar;19(3):27. doi: 10.1007/s11886-017-0836-z.
First-generation bioresorbable scaffolds (BRS), largely represented by the poly-l-lactic acid (PLLA) ABSORB (Abbott Vascular, Temecula, Illinois, US), have demonstrated, in low to moderate lesion complexity, similar efficacy to current generation metallic drug-eluting stents. However, a trend toward more device thrombosis has been observed, especially when the scaffolds are used in off-label situations. In this review, we address the most relevant drawbacks of these devices and, based on the available scientific data, we visit the scenarios where there is more uncertainty about their indication, trying to identify the lesions/patients to whom this technology should be voided at its current stage of development.
Based on available data from randomized trials and observational real world registries, the use of first generation BRS has been associated with a trend to higher acute/subacute thrombosis rate, which might be partially explained by the peculiarities related to their deployment technique, such as the need for precise vessel sizing and caution on post-dilation. Special attention should be paid when using these devices to treat small coronary arteries (<2.5 mm), long lesions requiring overlapping, and patients with acute coronary syndrome, in particular those with ST-segment elevation myocardial infarction (STEMI). Finally, the role of these devices is still uncertain in more complex lesion anatomies such as bifurcations, ostial lesions, etc. Although based on attractive clinical premises, the current indications of BRS are still limited by significant drawbacks observed in the first generation of these devices. Of note, new generation scaffolds are currently in preclinical and clinical evaluation and present features that might surpass most of these limitations.
第一代生物可吸收支架（BRS）主要以聚左旋乳酸（PLLA）材质的ABSORB支架（美国雅培血管公司，加利福尼亚州特梅库拉）为代表，在低至中度病变复杂程度的情况下，已显示出与当代金属药物洗脱支架相似的疗效。然而，已观察到器械血栓形成有增加的趋势，尤其是在支架用于非适应证情况时。在本综述中，我们阐述了这些器械最相关的缺点，并基于现有的科学数据，探讨了在其适应证方面存在更多不确定性的情况，试图确定在该技术当前发展阶段应避免使用的病变/患者。
基于随机试验和观察性真实世界注册研究的现有数据，第一代BRS的使用与急性/亚急性血栓形成率升高的趋势相关，这可能部分由其植入技术的特殊性所解释，例如需要精确的血管尺寸测量以及对后扩张操作要谨慎。在使用这些器械治疗小冠状动脉（<2.5mm）、需要重叠的长病变以及急性冠状动脉综合征患者，特别是ST段抬高型心肌梗死（STEMI）患者时，应格外注意。最后，在更复杂的病变解剖结构如分叉病变、开口病变等中，这些器械的作用仍不确定。尽管基于有吸引力的临床前提，但BRS的当前适应证仍受到在第一代这些器械中观察到的显著缺点的限制。值得注意的是，新一代支架目前正处于临床前和临床评估阶段，并且呈现出可能超越大多数这些限制的特性。
