Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial)

The purpose of this study was to report the angiographic findings of the first human evaluation of the everolimus-eluting stent (EES) for the treatment of noncomplex coronary lesions. Forty-two patients with de novo coronary lesions (2.75 to 4.00 mm vessels; lesion length, < 18 mm) were prospectively randomized in a 2:1 ratio to receive either the EES (n = 27) or a metallic stent (n = 15). Baselines clinical and angiographic characteristics were similar among both groups. At 6-month follow-up, EES had a lower instent late lumen loss (0.10 +/- 0.22 vs 0.85 +/- 0.32 mm, p < 0.0001) and in-segment diameter stenoses (20.7 +/- 12.3% vs 37.0 +/- 15.8%, p = 0.002). There was no in-stent restenosis with EES; however, 1 focal distal edge restenosis was present. There was 1 instent and 1 in-segment (proximal edge) restenosis in the metallic stent group. There was no stent thrombosis or aneurysm formation at follow-up in either group. (C) 2005 by Excerpta Medica Inc.