Author + information
- Received December 16, 2010
- Revision received February 22, 2011
- Accepted April 13, 2011
- Published online July 1, 2011.
- Giulio Guagliumi, MD⁎,⁎ (, )
- Hideyuki Ikejima, MD⁎,
- Vasile Sirbu, MD⁎,
- Hiram Bezerra, MD, PhD†,
- Giuseppe Musumeci, MD⁎,
- Nikoloz Lortkipanidze, MD⁎,
- Luigi Fiocca, MD⁎,
- Satoko Tahara, MD, PhD†,
- Angelina Vassileva, MD⁎,
- Aleksandre Matiashvili, MD⁎,
- Orazio Valsecchi, MD⁎ and
- Marco Costa, MD, PhD†
- ↵⁎Reprint requests and correspondence:
Dr. Giulio Guagliumi, Cardiovascular Department, Ospedali Riuniti di Bergamo, Largo Barozzi 1, 24128 Bergamo, Italy
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)
Supported by Ospedali Riuniti di Bergamo with grant support from Medtronic CardioVascular. Dr. Guagliumi has received grant/research support from Boston Scientific Corporation, Medtronic Vascular, LightLab Imaging, and Labcoat, and is a consultant for Boston Scientific Corporation, Cordis, and Volcano Corporation. Dr. Sirbu has received grant/research support from LightLab Imaging. Dr. Bezerra has received honoraria grants from St. Jude Medical. Dr. Costa is on the Speakers' Bureaus of and is a consultant for Daiichi-Sankyo, St. Jude, Boston Scientific Corporation, Sanofi-Aventis, Eli Lilly, and Medtronic; he is also on the Speakers' Bureaus of and is a member of the Scientific Advisory Boards for Abbott, Cordis, LightLab Imaging, and Scitech. All other authors have reported that they have no relationships to disclose.
- Received December 16, 2010.
- Revision received February 22, 2011.
- Accepted April 13, 2011.
- American College of Cardiology Foundation