One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial).
OBJECTIVE
Short-term results of durable polymer everolimus-eluting stents have shown significant improvements in clinical and angiographic outcomes. This report presents the 1-year clinical and angiographic data from the SPIRIT FIRST Trial.


RESULTS
This first-in-man single blind multi-centre randomized controlled trial assessed the safety and efficacy of everolimus and a durable polymer on a cobalt chromium stent in patients with de novo native coronary artery lesions. Of the 60 patients enrolled, a total of 56 patients (27 everolimus arm and 29 bare stent arm) were qualified to per-treatment analyses at 1 year. Quantitative angiographic and intravascular ultrasound (IVUS) analyses were performed. Angiographic late loss, IVUS neointimal volume obstruction and major adverse cardiac events (MACE) at 1 year were assessed as the study endpoints. At 1 year, the in-stent late loss and diameter stenosis of patients were 0.24 mm and 18% in the everolimus arm (n=20), as compared with 0.84 mm and 37% in the bare stent arm (n=25, p < 0.001). Significantly less neointimal hyperplasia was observed in the everolimus arm compared to the bare stent arm (neointimal volume, 13+/-9 mm3 vs. 37+/-17 mm3, p < 0.001; volume obstruction, 10+/-7% vs. 28+/-12%, p < 0.001). The overall MACE rate was 15.4% in the everolimus arm and 21.4% in the bare stent arm.


CONCLUSIONS
The safety and efficacy of everolimus-eluting stent with a durable polymer observed at 6 months was sustained at 1 year.
Tsuchida
Keiichi
K
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
Piek
Jan J
JJ
Neumann
Franz-Josef
FJ
van der Giessen
Willem J
WJ
Wiemer
Marcus
M
Zeiher
Andreas M
AM
Grube
Eberhard
E
Haase
Jürgen
J
Thuesen
Leif
L
Hamm
Christian W
CW
Veldhof
Susan
S
Dorange
Cécile
C
Serruys
Patrick W
PW