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). Baseline clinical and angiographic characteristics were similar among both groups. At 6-month follow-up, EES had a lower in-stent 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 in-stent 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.
Costa
Ricardo A
RA
Cardiovascular Research Foundation and Columbia University Medical Center, New York, New York 10022, USA.
Lansky
Alexandra J
AJ
Mintz
Gary S
GS
Mehran
Roxana
R
Tsuchiya
Yoshihiro
Y
Negoita
Manuela
M
Gilutz
Yael
Y
Nikolsky
Eugenia
E
Fahy
Martin
M
Pop
Ramona
R
Cristea
Ecaterina
E
Carlier
Stephane
S
Dangas
George
G
Stone
Gregg W
GW
Leon
Martin B
MB
Müller
Ralf
R
Techen
George
G
Grube
Eberhard
E
D000368:Aged; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000628:therapy*; D016503:Drug Delivery Systems; D000068338:Everolimus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D015607:Stents
D000068338:Everolimus; D020123:Sirolimus