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Several controlled trials report similar short–term clinical outcome of polymer–free drug–eluting stents compared with polymer–based drug–eluting stents. However, the long–term safety and efficacy in the high–risk subpopulation of patients with diabetes mellitus has not yet been extensively investigated. This study reports the 5–year results of the LIPSIA Yukon trial which randomized 236 patients with diabetes mellitus to a polymer–free sirolimus–eluting stent (Yukon Choice, Translumina, n=120) versus a polymer–based paclitaxel–eluting stent (Taxus Liberté, Boston Scientific, n=116) and had previously shown no significant difference in clinical outcome at 9 months.
A structured telephone interview was conducted to assess the clinical endpoints death, myocardial infarction, stent thrombosis, target lesion revascularization, target vessel revascularization, non–target vessel revascularization and stroke.
The median follow–up was 5.0 years (interquartile range 4.2 to 5.2). The incidence of all–cause death was 16.7% (n = 20) in the Yukon Choice versus 13.9% (n = 16) in the Taxus Liberté group (odds ratio [OR] 0.80; 95% confidence interval [CI] = 0.39 to 1.63; p = 0.67). Definite or presumed cardiovascular death occurred in 7.5% (n = 9) in the Yukon Choice and 8.6% (n = 10) in the Taxus Liberté group, respectively (OR 1.16; CI = 0.46 to 2.98; p = 0.94). There were no significant differences in the rates of myocardial infarction (9.2% versus 7.8%; OR 0.83; CI = 0.33 to 2.09; p = 0.88), definite stent thrombosis (0.8% versus 0.9%; OR 1.04; CI = 0.06 to 16.74; p = 1.0), target lesion revascularization (15% versus 15.5%; OR 1.04; CI = 0.51 to 2.12; p = 1.0), target vessel revascularization (18.3% versus 23.3%; OR 1.35; CI = 0.72 to 2.54; p = 0.44), non–target vessel revascularization (18.3% versus 26.7%; OR 1.63; CI = 0.88 to 3.02; p = 0.17) and stroke (3.3% versus 4.3%; OR 1.31; CI = 0.34 to 4.99; p = 0.96) between patients assigned to the Yukon Choice and the Taxus Liberté stent.
At 5 years of follow–up, clinical outcome was similar between the polymer–free sirolimus–eluting Yukon Choice stent and the polymer–based paclitaxel–eluting Taxus Liberté stent.
Poster Sessions, Expo North
Saturday, March 09, 2013, 10:00 a.m.–10:45 a.m.
Session Title: Coronary Stents
Abstract Category: 47. TCT@ACC–i2: Coronary Intervention, Devices
Presentation Number: 2101–228
- 2013 American College of Cardiology Foundation