首页> 外文期刊>European Heart Journal: The Journal of the European Society of Cardiology >A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents.
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A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents.

机译:冠状动脉疾病患者的无聚合物双药物洗脱支架:一项随机试验与基于聚合物的药物洗脱支架对比。

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AIMS: Long-term polymer residue in the coronary milieu is a consequence of current drug-eluting stent (DES) therapy and has been implicated in late adverse events. We developed a novel polymer-free rapamycin- and probucol-eluting stent (Dual-DES) and compared its efficacy against commercially available permanent polymer-based sirolimus-eluting (SES; Cypher) and zotarolimus-eluting (ZES; Endeavor) stents. METHODS AND RESULTS: Between March 2006 and July 2007, a total of 1007 patients undergoing coronary stenting of de novo lesions, in native vessels, were randomized to treatment with SES (n = 335), Dual-DES (n = 333), or ZES (n = 339). The primary endpoint was binary angiographic restenosis at 6-8 month follow-up angiography. Secondary endpoints were angiographic in-stent late loss; and target lesion revascularization (TLR), death/myocardial infarction and stent thrombosis at 12 months. Follow-up angiographic data were available for 828 (82.2%) patients. There was a significant difference in both binaryrestenosis and TLR across treatment groups (P = 0.003 and P < 0.001, respectively). Binary restenosis in the Dual-DES group (11.0%) was significantly lower than that in the ZES group (19.3%; P = 0.002) but comparable with that in the SES group (12.0%; P = 0.68). Similarly, TLR with Dual-DES (6.8%) was significantly lower than ZES (13.6%; P = 0.001) but not different to that of SES (7.2%; P = 0.83). These differences were mirrored in the extent of late loss across the groups. No differences were observed between stent groups in terms of death/myocardial infarction or stent thrombosis. CONCLUSION: A novel polymer-free Dual-DES is associated with high anti-restenotic efficacy without recourse to carrier polymer. Potential long-term clinical advantage of this platform remains subject to investigation. Study registered at ClinicalTrials.gov. Identifier number: NCT00332397.
机译:目的:冠状动脉环境中的长期聚合物残留是当前药物洗脱支架(DES)治疗的结果,并与晚期不良事件有关。我们开发了一种新型的无聚合物雷帕霉素和普罗布考洗脱支架(Dual-DES),并比较了其与市售的基于聚合物的永久性西罗莫司洗脱(SES; Cypher)和佐他莫司洗脱(ZES; Endeavor)支架的疗效。方法与结果:2006年3月至2007年7月,共有1007例从头开始在自然血管中进行了从头病变的冠状动脉支架置入术的患者,随机接受SES(n = 335),Dual-DES(n = 333)或ZES(n = 339)。主要终点为6-8个月的随访血管造影的二值血管造影再狭窄。次要终点是血管造影支架内晚期丢失;以及12个月时的目标病变血运重建(TLR),死亡/心肌梗塞和支架血栓形成。 828名(82.2%)患者可获得随访血管造影数据。各治疗组之间的二进制再狭窄和TLR均存在显着差异(分别为P = 0.003和P <0.001)。 Dual-DES组的二进制再狭窄(11.0%)明显低于ZES组的(19.3%; P = 0.002),但与SES组的二进制再狭窄(12.0%; P = 0.68)相当。同样,具有Dual-DES的TLR(6.8%)显着低于ZES(13.6%; P = 0.001),但与SES的差异(7.2%; P = 0.83)相同。这些差异反映在各组的后期损失程度上。在死亡/心肌梗塞或支架血栓形成方面,支架组之间未观察到差异。结论:新型无聚合物的双DES具有较高的抗再狭窄功效,而无需借助载体聚合物。该平台潜在的长期临床优势尚待研究。在ClinicalTrials.gov上注册的研究。标识符编号:NCT00332397。

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