Diletti Roberto, Ishibashi Yuki, Felix Cordula, Onuma Yoshinobu, Nakatani Shimpei, van Mieghem Nicolas M, Regar Eveliyn, Valgimigli Marco, de Jaegere Peter P, van Ditzhuijzen Nienke, Fam Jiang Ming, Ligthart Jurgen M R, Lenzen Mattie J, Serruys Patrick W, Zijlstra Felix, Jan van Geuns Robert
Thoraxcenter Erasmus MC, Rotterdam, The Netherlands.
Cardialysis BV, Rotterdam, The Netherlands.
Catheter Cardiovasc Interv. 2017 Jul;90(1):58-69. doi: 10.1002/ccd.26832. Epub 2016 Nov 29.
Limited data are currently available on the performance of everolimus eluting bioresorbable vascular scaffold (BVS) for treatment of complex coronary lesions representative of daily practice.
This is a prospective, mono-center, single-arm study, reporting data after BVS implantation in patients presenting with stable, unstable angina, or non-ST segment elevation myocardial infarction caused by de novo stenotic lesions in native coronary arteries. No restrictions were applied to lesion complexity. Procedural results and 12-month clinical outcomes were reported.
A total of 180 patients have been evaluated in the present study, with 249 treated coronary lesions. Device Success per lesion was 99.2%. A total of 119 calcified lesions were treated. Comparable results were observed among severe, moderate and noncalcified lesions in term of %diameter stenosis (%DS) (20.3 ± 10.5%, 17.8 ± 7.7%, 16.8 ± 8.6%; P = 0.112) and acute gain (1.36 ± 0.41 mm, 1.48 ± 0.44 mm, 1.56 ± 0.54 mm; P = 0.109). In bifurcations (54 lesions), side-branch ballooning after main vessel treatment was often performed (33.3%) with low rate of side-branch impairment (9.3%). A total of 29 cases with coronary total occlusions were treated. After BVS implantation %DS was not different from other lesion types (17.2 ± 9.4%, vs. 17.7 ± 8.6%; P = 0.780). At one year, all-cause mortality was reported in three cases. The rate of target lesion revascularization and target vessel revascularization was 3.3%. The rate of definite scaffold thrombosis was 2.6%.
The implantation of the everolimus eluting bioresorbable vascular scaffold in an expanded range of coronary lesion types and clinical presentations was observed to be feasible with promising angiographic results and mid-term clinical outcomes. © 2016 Wiley Periodicals, Inc.
目前关于依维莫司洗脱生物可吸收血管支架（BVS）治疗日常实践中具有代表性的复杂冠状动脉病变的性能数据有限。
这是一项前瞻性、单中心、单臂研究，报告了将BVS植入因原发性冠状动脉狭窄性病变导致稳定型、不稳定型心绞痛或非ST段抬高型心肌梗死患者后的相关数据。对病变复杂性未作限制。报告了手术结果和12个月的临床结局。
本研究共评估了180例患者，治疗了249处冠状动脉病变。每处病变的器械成功率为99.2%。共治疗了119处钙化病变。在严重、中度和非钙化病变中，就直径狭窄百分比（%DS）（20.3±10.5%，17.8±7.7%，16.8±8.6%；P = 0.112）和急性增益（1.36±0.41 mm，1.48±0.44 mm，1.56±0.54 mm；P = 0.109）而言，观察到类似结果。在分叉病变（54处）中，主血管治疗后常进行分支球囊扩张（33.3%），分支损伤率较低（9.3%）。共治疗了29例冠状动脉完全闭塞病例。BVS植入后%DS与其他病变类型无差异（17.2±9.4%，对比17.7±8.6%；P = 0.780）。一年时，报告有3例全因死亡。靶病变血运重建和靶血管血运重建率为3.3%。明确的支架血栓形成率为2.6%。
观察到在广泛的冠状动脉病变类型和临床表现中植入依维莫司洗脱生物可吸收血管支架是可行的，血管造影结果和中期临床结局前景良好。© 2016威利期刊公司
