AIM: 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. METHODS AND 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. CONCLUSION: The safety and efficacy of everolimus-eluting stent with a durable polymer observed at 6 months was sustained at 1 year.
RCT Entities:
AIM: 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. METHODS AND 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. CONCLUSION: The safety and efficacy of everolimus-eluting stent with a durable polymer observed at 6 months was sustained at 1 year.
Authors: Salvatore Brugaletta; Hector M Garcia-Garcia; Scot Garg; Josep Gomez-Lara; Roberto Diletti; Yoshinobu Onuma; Robert Jan van Geuns; Dougal McClean; Dariusz Dudek; Leif Thuesen; Bernard Chevalier; Stephan Windecker; Robert Whitbourn; Cecile Dorange; Karine Miquel-Hebert; Krishnankutty Sudhir; John A Ormiston; Patrick W Serruys Journal: Int J Cardiovasc Imaging Date: 2010-10-13 Impact factor: 2.357
Authors: M W Z Basalus; K Tandjung; K G van Houwelingen; M G Stoel; F H A F de Man; J W Louwerenburg; S A M Saïd; G C M Linssen; M A W J Kleijne; J van der Palen; J Huisman; P M J Verhorst; C von Birgelen Journal: Neth Heart J Date: 2010-08 Impact factor: 2.380
Authors: Marcel A M Beijk; Margo Klomp; Niels J W Verouden; Nan van Geloven; Karel T Koch; José P S Henriques; Jan Baan; Marije M Vis; Esther Scheunhage; Jan J Piek; Jan G P Tijssen; Robbert J de Winter Journal: Eur Heart J Date: 2009-11-18 Impact factor: 29.983