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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)

Martin B. Leon, MD^_*,_*, David E. Kandzari, MD, Eric L. Eisenstein, DBA, Kevin J. Anstrom, PhD, Laura Mauri, MD, MSc, Donald E. Cutlip, MD^||, Eugenia Nikolsky, MD^_*, Charles O'Shaughnessy, MD^¶, Paul A. Overlie, MD^#, Ajay J. Kirtane, MD^_*, Brent T. McLaurin, MD^_**, Stuart L. Solomon, MD, John S. Douglas, Jr, MD, Jeffrey J. Popma, MD^|| for the ENDEAVOR IV Investigators

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Scripps Clinic, La Jolla, California
Duke Medical Center, Durham, North Carolina
Harvard Clinical Research Institute, Brigham and Women's Hospital, Boston, Massachusetts
^|| Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
^¶ Elyria Memorial Hospital, Elyria, Ohio
^# Lubbock Heart Hospital, Lubbock, Texas
^_** Anderson Medical Center, Anderson, South Carolina
Methodist Hospital, Houston, Texas
Emory University, Atlanta, Georgia

^_* Reprint requests and correspondence: Dr. Martin B. Leon, Professor of Medicine and Associate Director, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, New York 10032 (Email: mleon{at}crf.org).

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)

Key Words: angioplasty • coronary disease • drug-eluting stent • revascularization • stent thrombosis

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   DRG = diagnosis-related group   MACE = major adverse cardiac events   MI = myocardial infarction   PES = paclitaxel-eluting stent(s)   QALY = quality-adjusted life year   ST = stent thrombosis   TLR = target lesion revascularization   TVF = target vessel failure   VLST = very late stent thrombosis   ZES = zotarolimus-eluting stent(s)

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