This Article Figures Only Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Web of Science (2) Citing Articles via Google Scholar Google Scholar Articles by Eisenstein, E. L. Search for Related Content PubMed Articles by Eisenstein, E. L. Related Collections Related Article

Long-Term Clinical and Economic Analysis of the Endeavor Zotarolimus-Eluting Stent Versus the Cypher Sirolimus-Eluting Stent

3-Year Results From the ENDEAVOR III Trial (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions)

Eric L. Eisenstein, DBA^_*,_*, Martin B. Leon, MD, David E. Kandzari, MD, Laura Mauri, MD, MSc, Rex Edwards, BA^_*, David F. Kong, MD^_*, Patricia A. Cowper, PhD^_*, Kevin J. Anstrom, PhD^_* for the ENDEAVOR III Investigators

^_* Duke Clinical Research Institute, Durham, North Carolina
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Scripps Clinic, La Jolla, California
Harvard Clinical Research Institute, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts

^_* Reprint requests and correspondence: Eric L. Eisenstein, Assistant Professor in Medicine, Duke Clinical Research Institute, 2400 Pratt Street, Terrace Level 0311, Durham, North Carolina 27705 (Email: eric.eisenstein{at}duke.edu).

Objectives: The aim of this study was to evaluate clinical and economic outcomes for subjects receiving zotarolimus-eluting (ZES) (n = 323) versus sirolimus-eluting stents (SES) (n = 113) in the ENDEAVOR III (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) clinical trial.

Background: Although previous clinical trials have evaluated long-term clinical outcome for drug-eluting stents, none considered their economic implications.

Methods: We analyzed case report form information with quality-of-life adjustment and Medicare cost weights applied from secondary sources; compared differences in clinical outcomes, quality-adjusted survival, medical resource use, and medical costs; and evaluated cost-effectiveness through 3-year follow-up.

Results: The use of ZES versus SES reduced the 3-year rates/100 subjects of death or myocardial infarction (3.9 vs. 10.8; difference, –6.9; 95% confidence interval [CI]: –13.0 to 0.8; p = 0.028), with no difference in target vessel revascularization rates (17.9 vs. 12.2; difference, 5.7; 95% CI: –3.7 to 15.1; p = 0.23) but greater use of coronary artery bypass graft (CABG) surgery (3.5 vs. 0.0; difference 3.5; 95% CI: 1.3 to 5.7; p = 0.002). After discounting at 3% per annum, total medical costs for ZES versus SES were similar ($23,353 vs. $21,657; difference, $1,696; 95% CI: –$1,089 to $4,482, p = 0.23), and the 3-year cost-effectiveness ratio was $57,002/quality-adjusted life year.

Conclusions: Despite a reduction in death or myocardial infarction and no difference in total revascularizations, medical costs were not decreased due to increased CABG repeat revascularization procedures for subjects receiving ZES versus SES. If future trials observe similar differences, improved safety with no difference in medical costs, the use of ZES versus SES will be a clinically and economically attractive treatment strategy. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256)

Key Words: coronary disease • cost analysis • drug-eluting stent • revascularization

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary artery bypass graft   CK-MB = creatine kinase-myocardial band   DES = drug-eluting stent(s)   DRG = diagnosis-related group   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   QALY = quality-adjusted life year   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVR = target vessel revascularization   ZES = zotarolimus eluting stent(s)

Related Article

Second-Generation Drug-Eluting Stents and the Continuous Need for Rapidly Available Real-World Data

Debabrata Mukherjee and David J. Moliterno
J. Am. Coll. Cardiol. Intv. 2009 2: 1236-1239. [Full Text] [PDF]

This article has been cited by other articles:

				E. R. Bates and D. S. Menees My Stent Is Better Than Your Stent...Or Is It? J. Am. Coll. Cardiol. Intv., May 1, 2011; 4(5): 551 - 553. [Full Text] [PDF]

				L. Mauri, J. M. Massaro, S. Jiang, I. Meredith, W. Wijns, J. Fajadet, D. E. Kandzari, M. B. Leon, D. E. Cutlip, and K. P. Thompson Long-Term Clinical Outcomes With Zotarolimus-Eluting Versus Bare-Metal Coronary Stents J. Am. Coll. Cardiol. Intv., December 1, 2010; 3(12): 1240 - 1249. [Abstract] [Full Text] [PDF]

				S. Garg and P. W. Serruys Coronary Stents: Current Status J. Am. Coll. Cardiol., August 31, 2010; 56(10_Suppl_S): S1 - S42. [Abstract] [Full Text] [PDF]

				S. Windecker and L. Raber The DESIRE-Late Registry: What Is Left to Be Desired? J. Am. Coll. Cardiol. Intv., January 1, 2010; 3(1): 19 - 21. [Full Text] [PDF]

				D. Mukherjee and D. J. Moliterno Second-Generation Drug-Eluting Stents and the Continuous Need for Rapidly Available Real-World Data J. Am. Coll. Cardiol. Intv., December 1, 2009; 2(12): 1236 - 1239. [Full Text] [PDF]