OBJECTIVES: We assessed the in vivo vascular response to a new generation of zotarolimus-eluting stents (ZES) with prolonged drug release (Resolute ZES-SR, Medtronic Vascular, Santa Rosa, California) compared with ZES with faster kinetics (Endeavor ZES-FR, Medtronic Vascular) by optical coherence tomography. BACKGROUND: Local drug release kinetics has been implicated with antirestenosis efficacy of drug-eluting stents. However, the impact of different release kinetics on vascular response of diseased human coronary arteries remains to be investigated. METHODS: The study population consisted of 43 patients with long lesions in native coronary vessels treated with multiple overlapping ZES. Twenty-one patients treated with ZES-SR were compared with 22 patients treated with ZES-FR from the ODESSA (Optical coherence tomography for DES SAfety) study. The primary endpoint was in-stent neointimal hyperplasia as assessed by optical coherence tomography at 6-month follow-up. Coprimary endpoints were the percentage of uncovered and malapposed struts. RESULTS:Strut-level median neointimal thickness was 0.11 mm (interquartile range [IQR]: 0.07 to 0.15 mm) in ZES-SR and 0.31 mm (IQR: 0.27 to 0.42 mm) in ZES-FR, respectively (p < 0.001). The 6-month rate of uncovered struts per patient was 7.38% (IQR: 3.06% to 12.72%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001); rate of malapposed and uncovered struts was 1.47% (IQR: 0.32% to 4.23%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001). CONCLUSIONS: This study demonstrated the impact of different release kinetics on human in vivo vascular response to ZES implantation. The new generation of ZES-SR compared with ZES-FR had better suppression of the neointimal response but higher proportion of uncovered and malapposed struts at 6-month optical coherence tomography follow-up. (Optical Coherence Tomography in Long Lesions [LongOCT]; NCT01133925).
RCT Entities:
OBJECTIVES: We assessed the in vivo vascular response to a new generation of zotarolimus-eluting stents (ZES) with prolonged drug release (Resolute ZES-SR, Medtronic Vascular, Santa Rosa, California) compared with ZES with faster kinetics (Endeavor ZES-FR, Medtronic Vascular) by optical coherence tomography. BACKGROUND: Local drug release kinetics has been implicated with antirestenosis efficacy of drug-eluting stents. However, the impact of different release kinetics on vascular response of diseased human coronary arteries remains to be investigated. METHODS: The study population consisted of 43 patients with long lesions in native coronary vessels treated with multiple overlapping ZES. Twenty-one patients treated with ZES-SR were compared with 22 patients treated with ZES-FR from the ODESSA (Optical coherence tomography for DES SAfety) study. The primary endpoint was in-stent neointimal hyperplasia as assessed by optical coherence tomography at 6-month follow-up. Coprimary endpoints were the percentage of uncovered and malapposed struts. RESULTS: Strut-level median neointimal thickness was 0.11 mm (interquartile range [IQR]: 0.07 to 0.15 mm) in ZES-SR and 0.31 mm (IQR: 0.27 to 0.42 mm) in ZES-FR, respectively (p < 0.001). The 6-month rate of uncovered struts per patient was 7.38% (IQR: 3.06% to 12.72%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001); rate of malapposed and uncovered struts was 1.47% (IQR: 0.32% to 4.23%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001). CONCLUSIONS: This study demonstrated the impact of different release kinetics on human in vivo vascular response to ZES implantation. The new generation of ZES-SR compared with ZES-FR had better suppression of the neointimal response but higher proportion of uncovered and malapposed struts at 6-month optical coherence tomography follow-up. (Optical Coherence Tomography in Long Lesions [LongOCT]; NCT01133925).
Authors: Natalie Artzi; Abraham R Tzafriri; Keith M Faucher; Geoffrey Moodie; Theresa Albergo; Suzanne Conroy; Scott Corbeil; Paul Martakos; Renu Virmani; Elazer R Edelman Journal: Ann Biomed Eng Date: 2015-08-28 Impact factor: 3.934
Authors: C A Given; G F Attizzani; M R Jones; C N Ramsey; W H Brooks; M A Costa; H G Bezerra Journal: AJNR Am J Neuroradiol Date: 2013-02-07 Impact factor: 3.825
Authors: Franz Bozsak; David Gonzalez-Rodriguez; Zachary Sternberger; Paul Belitz; Thomas Bewley; Jean-Marc Chomaz; Abdul I Barakat Journal: PLoS One Date: 2015-06-17 Impact factor: 3.240