Author + information
- Received April 10, 2017
- Revision received May 1, 2017
- Accepted May 4, 2017
- Published online July 17, 2017.
- Matthew J. Price, MDa,∗ (, )
- Shigeru Saito, MDb,
- Richard A. Shlofmitz, MDc,
- Douglas J. Spriggs, MDd,
- Michael Attubato, MDe,
- Brent McLaurin, MDf,
- Alexandra Popma Almonacid, MDg,
- Sandeep Brar, MDh,
- Minglei Liu, PhDh,
- Elizabeth Moe, BAh and
- Roxana Mehran, MDi
- aDepartment of Cardiovascular Diseases, Scripps Clinic, La Jolla, California
- bShonan Kamakura General Hospital, Kamakura, Japan
- cSaint Francis Hospital, Roslyn, New York
- dMorton Plant Hospital, Clearwater, Florida
- eNYU Langone Medical Center, New York, New York
- fAnMed, Anderson, South Carolina
- gBeth Israel Deaconess Medical Center, Cardiovascular Imaging Core Laboratory, Boston, Massachusetts
- hMedtronic, Santa Rosa, California
- iDepartment of Cardiology, Mount Sinai Medical Center, New York, New York
- ↵∗Address for correspondence:
Dr. Matthew J. Price, Scripps Clinic, Department of Cardiovascular Diseases, 9898 Genesee Avenue, AMP-200, La Jolla, California 92037.
Objectives The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD).
Background Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation.
Methods This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure.
Results A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%.
Conclusions In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501)
- drug-eluting stent(s)
- percutaneous coronary intervention
- reference vessel diameter
- Resolute Onyx
This study was supported by Medtronic. Dr. Price has received consulting honoraria from AstraZeneca, ACIST Medical, Boston Scientific, Medtronic, St. Jude Medical, and The Medicines Company; and has received speaking fees from AstraZeneca, Abbott Vascular, Medtronic, St. Jude Medical, and The Medicines Company. Dr. Shlofmitz is a member of the Speakers Bureau for CSI. Dr. Attubato has received consulting honoraria from Boston Scientific, Cook Medical, and Medtronic; and has received research grants from Boston Scientific and Medtronic. Dr. Popma Almonacid has received institutional grants from Medtronic, Boston Scientific, and Abbott Vascular. Dr. Mehran has received consulting honoraria from Medscape, Shanghai BraccoSine Pharmaceutical, and Abbott; has participated on the Data Safety Monitoring Board for Watermark Research Planners; has received research grants from Abbott Vascular, AstraZeneca, Bayer Healthcare Pharmaceuticals, Bristol-Myers Squibb Company, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, and The Medicines Company; and has received other support from Janssen Pharmaceuticals and Wiley Blackwell. Dr. Brar, Dr. Liu, and Ms. Moe are employees of Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 10, 2017.
- Revision received May 1, 2017.
- Accepted May 4, 2017.
- 2017 The Authors