在新发冠状动脉病变患者中，与紫杉醇洗脱支架相比，依维莫司洗脱支架的安全性、疗效和成本效益：来自 ENDEAVOR IV 试验的 2 年随访结果（美敦力 Endeavor 药物[ABT-578]洗脱冠状动脉支架系统与紫杉醇洗脱 Taxus 冠状动脉支架系统在新发原生冠状动脉病变中的随机对照试验）。
Late safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent compared with a paclitaxel-eluting stent in patients with de novo coronary lesions: 2-year follow-up from the ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).
机构信息
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York 10032, USA.
出版信息
JACC Cardiovasc Interv. 2009 Dec;2(12):1208-18. doi: 10.1016/j.jcin.2009.10.008.
OBJECTIVES
The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions.
BACKGROUND
Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials.
METHODS
The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES.
RESULTS
The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non-Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar.
CONCLUSIONS
After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).
目的
本研究旨在观察随访 2 年后，与紫杉醇洗脱支架（PES）相比，新型佐他莫司洗脱支架（ZES）在治疗原发性冠状动脉病变患者中的安全性、疗效和成本效益。
背景
早期药物洗脱支架与非常晚期支架血栓形成（VLST）的小但显著的发生率相关，这种情况发生在索引手术后 1 年以上。ZES 在临床试验中取得了令人鼓舞的结果。
方法
ENDEAVOR IV 试验（随机、多中心、单盲、平行对照试验），比较 ZES 与 PES 在治疗原发性冠状动脉单病变患者中的疗效。1548 例患者按 1:1 比例随机分组。96.0%的 ZES 患者和 95.4%的 PES 患者获得了 2 年随访。主要终点是靶血管失败（TVF），安全性终点包括学术研究联合会定义的支架血栓形成。经济终点分析包括质量调整生存、医疗成本以及 ZES 和 PES 的相对成本效益。
结果
2 年时，ZES 组和 PES 组的 TVF 相似（11.1% vs. 13.1%，p = 0.232）。ZES 组心肌梗死（MI）较少（p = 0.022），主要是由于围手术期非 Q 波型 MI 较少，1-2 年内迟发性 MI 较少。迟发性 MI 与 VLST 增加相关（PES：6 例 vs. ZES：1 例；p = 0.069）。与 PES 相比，ZES 组的靶病变血运重建率相似（5.9% vs. 4.6%；p = 0.295），特别是在没有计划进行血管造影随访的患者中（5.2% vs. 4.9%；p = 0.896）。ZES 和 PES 的成本效益相似。
结论
随访 2 年后，ZES 显示出与 PES 相当的疗效和成本效益，心肌梗死更少，VLST 趋势更低。
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