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).

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).