ISAResearch Center, Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, 80636 Munich, Germany.
Eur Heart J. 2009 Oct;30(20):2441-9. doi: 10.1093/eurheartj/ehp352. Epub 2009 Aug 30.
Although biodegradable polymer drug-eluting stent (DES) platforms have potential to enhance long-term clinical outcomes, data concerning their efficacy are limited to date. We previously demonstrated angiographic antirestenotic efficacy with a microporous, biodegradable polymer DES. In the current study, we hypothesized that at 12 months, its clinical safety and efficacy would be non-inferior to that of permanent polymer DES.
This prospective, randomized, open-label, active-controlled trial was conducted at two tertiary referral cardiology centres in Munich, Germany. Patients presenting with stable coronary disease or acute coronary syndromes undergoing DES implantation in de novo native-vessel coronary lesions were randomly assigned to treatment with biodegradable polymer DES (rapamycin-eluting; n = 1299) or permanent polymer DES (n = 1304: rapamycin-eluting, Cypher, n = 652; or everolimus-eluting, Xience, n = 652) and underwent clinical follow-up to 1 year. The primary endpoint was a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or revascularization related to the target lesion (TLR). Biodegradable polymer DES was non-inferior to permanent polymer DES concerning the primary endpoint [13.8 vs. 14.4%, respectively, P(non-inferiority) 0.005; relative risk = 0.96 (95% confidence interval, 0.78-1.17), P(superiority) = 0.66]. Biodegradable polymer DES in comparison with permanent polymer DES showed similar rates of cardiac death or MI related to the target vessel (6.3 vs. 6.2%, P = 0.94), TLR (8.8 vs. 9.4%, P = 0.58), and stent thrombosis (definite/probable: 1.0 vs. 1.5%, P = 0.29). Subgroup analysis of the biodegradable polymer DES vs. individual Cypher and Xience stent arms revealed no signal of performance difference.
A biodegradable polymer rapamycin-eluting stent is non-inferior to permanent polymer-based DES in terms of clinical efficacy over 1 year. These results provide a framework for testing the potential clinical advantage of biodegradable polymer DES over the medium to long term. The trial was registered at ClinicalTrials.gov (identifier: NCT00598676).
尽管可生物降解聚合物药物洗脱支架（DES）平台具有改善长期临床结果的潜力，但迄今为止，关于其疗效的数据有限。我们之前已经证明了微孔可生物降解聚合物 DES 的血管造影抗再狭窄疗效。在本研究中，我们假设在 12 个月时，其临床安全性和疗效不劣于永久性聚合物 DES。
这项前瞻性、随机、开放标签、阳性对照试验在德国慕尼黑的两个三级转诊心脏病学中心进行。患有稳定型冠心病或急性冠状动脉综合征的患者，在初次接受原生血管病变的 DES 植入治疗时，被随机分配接受可生物降解聚合物 DES（雷帕霉素洗脱；n = 1299）或永久性聚合物 DES（n = 1304：雷帕霉素洗脱，Cypher，n = 652；或依维莫司洗脱，Xience，n = 652）治疗，并接受 1 年的临床随访。主要终点是心脏死亡、与靶血管相关的心肌梗死（MI）或与靶病变相关的血运重建（TLR）的复合终点。可生物降解聚合物 DES 在主要终点方面不劣于永久性聚合物 DES [分别为 13.8%和 14.4%，P（非劣效性）<0.005；相对风险=0.96（95%置信区间，0.78-1.17），P（优效性）=0.66]。与永久性聚合物 DES 相比，可生物降解聚合物 DES 显示出相似的靶血管相关心脏死亡或 MI 发生率（6.3%比 6.2%，P = 0.94）、TLR（8.8%比 9.4%，P = 0.58）和支架血栓形成（确定/可能：1.0%比 1.5%，P = 0.29）。可生物降解聚合物 DES 与单个 Cypher 和 Xience 支架的亚组分析显示，性能差异无信号。
在 1 年的临床疗效方面，可生物降解聚合物雷帕霉素洗脱支架不劣于基于永久性聚合物的 DES。这些结果为测试可生物降解聚合物 DES 在中长期的潜在临床优势提供了框架。该试验在 ClinicalTrials.gov（标识符：NCT00598676）上注册。
