Everaert B, Wykrzykowska J J, Koolen J, van der Harst P, den Heijer P, Henriques J P, van der Schaaf R, de Smet B, Hofma S H, Diletti R, Weevers A, Hoorntje J, Smits P, van Geuns R J
Thoraxcenter, Erasmus Medical Centre, Rotterdam, The Netherlands.
Monica Hospital, Antwerp, Belgium.
Neth Heart J. 2017 Jul;25(7-8):419-428. doi: 10.1007/s12471-017-1014-z.
To eliminate some of the potential late limitations of permanent metallic stents, the bioresorbable coronary stents or 'bioresorbable vascular scaffolds' (BVS) have been developed.
We reviewed all currently available clinical data on BVS implantation.
Since the 2015 position statement on the appropriateness of BVS in percutaneous coronary interventions, several large randomised trials have been presented. These have demonstrated that achieving adequate 1 and 2 year outcomes with these first-generation BVS is not straightforward. These first adequately powered studies in non-complex lesions showed worse results if standard implantation techniques were used for these relatively thick scaffolds. Post-hoc analyses hypothesise that outcomes similar to current drug-eluting stents are still possible if aggressive lesion preparation, adequate sizing and high-pressure postdilatation are implemented rigorously. As long as this has not been confirmed in prospective studies the usage should be restricted to experienced centres with continuous outcome monitoring. For more complex lesions, results are even more disappointing and usage should be discouraged. When developed, newer generation scaffolds with thinner struts or faster resorption rates are expected to improve outcomes. In the meantime prolonged dual antiplatelet therapy (DAPT, beyond one year) is recommended in an individualised approach for patients treated with current generation BVS.
The new 2017 recommendations downgrade and limit the use of the current BVS to experienced centres within dedicated registries using the updated implantation protocol and advise the prolonged usage of DAPT. In line with these recommendations the manufacturer does not supply devices to the hospitals without such registries in place.
为消除永久性金属支架的一些潜在晚期局限性，已研发出生物可吸收冠状动脉支架或“生物可吸收血管支架”（BVS）。
我们回顾了目前所有关于BVS植入的临床数据。
自2015年关于BVS在经皮冠状动脉介入治疗中适用性的立场声明以来，已有多项大型随机试验公布。这些试验表明，使用这些第一代BVS实现足够的1年和2年疗效并非易事。在非复杂病变中进行的这些首次有足够样本量的研究表明，如果对这些相对较厚的支架采用标准植入技术，结果会更差。事后分析推测，如果严格实施积极的病变预处理、合适的尺寸选择和高压后扩张，仍有可能获得与当前药物洗脱支架相似的疗效。只要这一点尚未在前瞻性研究中得到证实，其使用应限于有经验的中心，并持续监测结果。对于更复杂的病变，结果更令人失望，应不鼓励使用。新一代支架研发出来后，预计其支架小梁更细或吸收速度更快，会改善疗效。与此同时，对于接受当前一代BVS治疗的患者，建议采用个体化方法延长双联抗血小板治疗（DAPT，超过一年）。
2017年的新建议降低了当前BVS的使用级别，并将其使用限制在使用更新植入方案的专门注册研究中有经验的中心，同时建议延长DAPT的使用时间。根据这些建议，制造商不会向没有此类注册研究的医院供应设备。
