[CIT2014]生物可吸收支架:期待长期高质量证据——哥伦比亚大学医学中心Gregg W. Stone教授专访
Gregg W.Stone教授 哥伦比亚大学医学中心
专家介绍:Stone教授是哥伦比亚大学医学中心及纽约长老会医院血管介入治疗中心心血管研究与教育部主任,曾参与50多项多中心随机对照研究。其主要的研究领域涉及急性冠状动脉综合征及心肌梗死的介入治疗、药物洗脱支架、辅助药理学、经皮心脏瓣膜、血管内超声成像、慢性完全闭塞性病变、易损斑块、造影剂肾病、临床试验设计及监管问题等方面。
生物可吸收支架(BRS)具有非常广阔的应用前景,很多人都对其未来充满着期待,但目前其尚缺乏足够的数据支持,并存在一些尚未解决的问题。作为ABSORB III及ABSORB IV研究的研究者,我认为这两项大型研究,具有较高的质量及效力来解答BRS与药物洗脱支架优势对比等方面的问题。ABSORB III研究初步结果显示,XINECE依维莫司洗脱支架与BRS组患者的一年内事件发生率相当;与药物洗脱支架相比,BRS的一年内事件发生率具有非劣效性。ABSORB IV研究则将进一步探讨与药物洗脱支架相比,BRS的一年内心绞痛发生率是否更少以及BRS能否改善支架植入后1~5年内的整体无事件生存率。目前BRS尚处于发展的早期阶段,其长期疗效亟需长期大型随机试验的验证,而ABSORB III及ABSORB IV系列研究结果则将为我们带来答案。
在我们充分证实“与金属药物洗脱支架相比BRS疗效相当或更好”之前,金属药物洗脱支架仍是患者的标准治疗之选。至少目前来看,BRS尚无法完全取代金属药物洗脱支架。与BRS相比,后者的机械性更好,更适用于分叉病变、钙化病变及弥漫性远端病变。现阶段第一代BRS的支撑结构较厚,球囊回撤并不理想,相信随着时间的推移上述问题会逐步得到解决。不过,目前来说,金属药物洗脱支架仍具有显著的应用优势,尤其是在上述特殊病变患者中。
Bioresorbable scaffoldings(hereinafterreferred to as BRS)have very broad application prospects, and many peopleare looking forwards for their future. However, at present the corresponding data and evidence are still not quite adequate and there are some unanswered questions about BRS. As the involver of the ABSORB III and ABSORB IV trials, I am confident about them. I think they are large enough, adequately powered enough and high quality enough to do comparisonbetween BRS and DES. The initial results of ABSORB III showed that there was non-inferiority in the clinical events in the first year between XINCE everolimus eluting stents and ABSORB BRS. ABSORB IV will further investigate whether BRS bringsfewer anginas in the first year and has higher overall event-free survival rates between years 1 and 5. At present, BRS is still in an early stage and needs to be further verified in long-term large pivotal randomized trials. The ongoing ABSORB III and ABSORB IV trials will give answers for us.
In my mind,metallic DES really remains the standard of care until we have proven that BRS are as good or better. I do not see BRS at least in their current formats ever replacing metallic DES entirely because the mechanical properties of metallic DES are better and they are more suited for patients with bifurcation lesions, calcified lesions and diffuse distal disease. The struts of the first generation BRS are thick, while the balloon retention is not so good. All these questions need to be resolved and will surely be improved over time. However, right now metallic DES still has clear advantages especially in patient with the above particular lesions.
(来源:《国际循环》CIT2014特刊)