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Long-Term Clinical and Economic Analysis of the Endeavor Drug-Eluting Stent Versus the Driver Bare-Metal Stent

4-Year Results From the ENDEAVOR II Trial (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions)

Eric L. Eisenstein, DBA^_*,_*, William Wijns, MD, PhD, Jean Fajadet, MD, Laura Mauri, MD, MSc, Rex Edwards, BA^_*, Patricia A. Cowper, PhD^_*, David F. Kong, MD, AM^_*, Kevin J. Anstrom, PhD^_*

^_* Duke Clinical Research Institute, Durham, North Carolina
Cardiovascular Center, Aalst, Belgium
Clinique Pasteur, Toulouse, France
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: This study was designed to evaluate long-term clinical and economic outcomes for subjects receiving Endeavor drug-eluting versus Driver bare-metal stents (both Medtronic CardioVascular, Santa Rosa, California).

Background: Early studies found that the drug-eluting stent (DES) was a clinically and economically attractive alternative to the bare-metal stent; however, associations between DES and very late stent thrombosis suggest that longer follow-up is required.

Methods: We used clinical, resource use and follow-up data from 1,197 subjects randomized to receive Endeavor (n = 598) versus Driver (n = 599) stents in ENDEAVOR II (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions) study with Medicare cost weights and quality of life adjustments applied from secondary sources. We compared differences through 4-year follow-up (1,440 days).

Results: Patients in both treatment groups had similar baseline characteristics. The use of Endeavor versus Driver reduced 4-year target vessel revascularization rates per 100 subjects (10.4 vs. 21.5; difference: –11.1; 95% confidence interval [CI]: –16.0 to –6.1; p < 0.001), with no difference in the rates per 100 subjects of death (5.0 vs. 5.2; difference: –0.2; 95% CI: –2.7 to 2.4; p = 0.90) or nonfatal myocardial infarction (3.2 vs. 4.4; difference: –1.2; 95% CI: –3.4 to 1.0; p = 0.29). After discounting at a 3% annual rate, there were no differences in quality-adjusted survival days (1,093 vs. 1,090; difference: 3; 95% CI: –13 to 19; p = 0.69) and total medical costs ($21,483 vs. $21,680; difference: –$198; 95% CI: –$1,608 to $1,207; p = 0.78).

Conclusions: The use of Endeavor versus Driver was associated with a significant reduction in target vessel revascularization through 4-year follow-up with no difference in death, nonfatal myocardial infarction, quality-adjusted survival, or total medical costs. These results are comparable to those for other studies evaluating drug-eluting versus bare-metal stents. (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions [ENDEAVOR II]; NCT00614848)

Key Words: drug-eluting stents • bare-metal stents • coronary disease • revascularization • cost analysis

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary artery bypass graft   CAD = coronary artery disease   DES = drug-eluting stent(s)   DRG = diagnosis-related group   MACE = major adverse cardiac events   MI = myocardial Infarction   PCI = percutaneous coronary intervention   QALY = quality-adjusted life-year   SAE = serious adverse events   TVF = target vessel failure   TVR = target vessel revascularization   ZES = zotarolimus-eluting stent(s)

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