First human experience with the 17-beta-estradiol-eluting stent - The Estrogen And Stents To Eliminate Restenosis (EASTER) Trial
First human experience with the 17-beta-estradiol-eluting stent - The Estrogen And Stents To Eliminate Restenosis (EASTER) Trial
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DOI：
10.1016/j.jacc.2004.01.023
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发表时间：
2004-03-17
影响因子：
24
通讯作者：
Sousa, JE
中科院分区：
文献类型：
--
作者：
Abizaid, A;Albertal, M;Sousa, JE
目的探讨17-β-雌二醇洗脱支架置入治疗冠状动脉新生病变的安全性和有效性。背景：最近的动物实验表明，17-β-雌二醇可促进血管内皮化，抑制细胞迁移和增殖，防止再狭窄。方法连续30例患者接受了17-β-雌二醇洗脱BiodVysio(英国伦敦BioCompatible Ltd.)支架植入术。6个月后进行临床、血管造影和血管内超声(IVUS)分析。结果所有支架均成功置入，患者均出院，无临床事件发生。通过血管造影术，共有两名患者的支架内狭窄超过50%，而没有患者发生边缘再狭窄。1例支架内局灶性再狭窄(直径60%狭窄)，无症状，负荷试验阴性，另1例弥漫性再狭窄，需要靶血管再血管化。没有其他患者经历过任何重大的不良心脏事件。血管内超声显示新生内膜增生体积为32.3±16.4 mm(3例)，支架体积为143.7±43.7 mm(3例)，导致新生内膜体积梗阻23.5±12.5%。结论17-β-雌二醇洗脱BiodVysio支架置入是安全可行的，具有较低的再狭窄和血管重建率。这些结果需要通过一项大型随机多中心试验进一步证实。
OBJECTIVES The purpose of the study was to examine the safety and efficacy of 17-beta-estradiol-eluting stent implantation on coronary de novo lesions.BACKGROUND Recent animal data indicate that local delivery of 17-beta-estradiol promotes reendothelialization, inhibits cell migration and proliferation, and prevents restenosis.METHODS A total of 30 consecutive patients underwent 17-beta-estradiol-eluting BiodVysio (Biocompatibles Ltd., London, United Kingdom) stent implantation for the treatment of coronary de novo lesions. Clinical, angiographic, and intravascular ultrasound (IVUS) analysis was performed at six-month follow-up.RESULTS All stents were successfully deployed and patients were discharged home without clinical events. A total of two patients exceeded 50% intra-stent narrowing by angiography, whereas no patients experienced edge restenosis. One patient had focal intra-stent restenosis (60% diameter stenosis) with no symptoms and negative stress test, whereas the other patient had diffuse restenosis, requiring target vessel revascularization. No other patient experienced any major adverse cardiac event. Follow-up IVUS revealed a neointimal hyperplasia volume of 32.3 +/- 16.4 mm(3), whereas the stent volume was 143.7 +/- 43.7 mm(3), resulting in a neointimal volume obstruction of 23.5 +/- 12.5%. None of the patients had greater than or equal to50% volume obstruction by IVUS.CONCLUSIONS Implantation of 17-beta-estradiol-eluted BiodVysio stents appears feasible and safe, showing low rates of binary restenosis and revascularization. These results warrant further confirmation with a large, randomized multicenter trial.