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 End

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• 作者：Martin B. Leon ; MD^?/sup> ; ^{mleon@crf.org} ; David E. Kandzari ; MD^&dagger ; ; Eric L. Eisenstein ; DBA^&Dagger ; ; Kevin J. Anstrom ; PhD^&Dagger ; ; Laura Mauri ; MD ; MSc^§ ; ; Donald E. Cutlip ; MD^?/sup> ; Eugenia Nikolsky ; MD^?/sup> ; Charles O'Shaughnessy ; MD^¶ ; ; Paul A. Overlie ; MD^# ; Ajay J. Kirtane ; MD^?/sup> ; Brent T. McLaurin ; MD^?? ; Stuart L. Solomon ; MD^&dagger ; &dagger ; ; John S. Douglas Jr ; MD^&Dagger ; &Dagger ; ; Jeffrey J. Popma ; MD^?/sup> ; ENDEAVOR IV Investigators
• 关键词：angioplasty ; coronary disease ; drug-eluting stent ; revascularization ; stent thrombosis
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2009
• 出版时间：December 2009
• 年：2009
• 卷：2
• 期：12
• 页码：1208-1218
• 全文大小：718 K

文摘

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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¨CQ-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; )