Author + information
- Received April 10, 2017
- Revision received May 1, 2017
- Accepted May 4, 2017
- Published online May 17, 2017.
- Matthew J. Price, MD1,∗ (, )
- Shigeru Saito, MD2,
- Richard A. Shlofmitz, MD3,
- Douglas J. Spriggs, MD4,
- Michael Attubato, MD5,
- Brent McLaurin, MD6,
- Alexandra Popma Almonacid, MD7,
- Sandeep Brar, MD8,
- Minglei Liu, PhD8,
- Elizabeth Moe, BA8 and
- Roxana Mehran, MD9
- 1Department of Cardiovascular Diseases, Scripps Clinic, La Jolla, California
- 2Shonan Kamakura General Hospital, Kamakura, Japan
- 3Saint Francis Hospital, Roslyn, New York
- 4Morton Plant Hospital, Clearwater, Florida
- 5NYU Langone Medical Center, New York, New York
- 6AnMed, Anderson, South Carolina
- 7Beth Israel Deaconess Medical Center, Cardiovascular Imaging Core Laboratory, Boston, Massachusetts
- 8Medtronic, Santa Rosa, California
- 9Department of Cardiology, Mount Sinai Medical Center, New York, New York
- ↵∗Correspondence to: Matthew J. Price MD 9898 Genesee Avenue AMP-200 La Jolla, CA 92037 Tel: (858) 824-5269.
Objective To explore the safety and efficacy of a dedicated drug-eluting stent (DES) for the treatment of coronary lesions with very small reference vessel diameter (RVD).
Background Smaller RVD is associated with increased risk of restenosis and target lesion failure (TLF) after stent implantation.
Methods This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0mm zotarolimus-eluting stent (ZES). 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 ≤27mm in length and RVD ≥2.0 and <2.25mm 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 were diabetic, the mean lesion length was 12.6±6.3mm 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 (LLL) was 0.26±0.48 mm and the rate of binary restenosis was 12.0%.
Conclusions In this first report of a DES with a dedicated size to treat lesions with RVD <2.25mm, the Resolute Onyx 2.0 mm ZES was associated with a low rate of TLF and LLL, without a signal for stent thrombosis. This novel-sized DES appears to be a feasible option for the treatment of coronary lesions in extremely small vessels.
- Resolute Onyx
- drug-eluting stent
- percutaneous coronary intervention
- reference vessel diameter
This study was supported by Medtronic (Santa Rosa, California).
Dr. Price reports consulting honoraria from AstraZeneca, ACIST Medical, Boston Scientific, Medtronic, St. Jude Medical, and The Medicines Company; and Speaker’s fees from AstraZeneca, Abbott Vascular, Medtronic, St. Jude Medical and The Medicines Company.
Dr. Shlofmitz is on the speakers’ bureau for CSI.
Dr. Attubato reports consulting honoraria from Boston Scientific, Cook Medical and Medtronic; and research grants from Boston Scientific and Medtronic.
Dr. Popma Almonacid receives institutional grants from Medtronic, Boston Scientific and Abbott Vascular.
Dr. Mehran reports consulting honoraria from Medscape, Shanghai BraccoSine Pharmaceutical Corp and Abbott; participation on Data Safety Monitoring Board for Watermark Research Planners; research grants from Abbott Vascular, AstraZeneca, Bayer Healthcare Pharmaceuticals, Bristol-Myers Squibb Company, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, The Medicines Company; and other support from Janssen Pharmaceuticals, Inc. and Wiley Blackwell Publishing Company.
Dr. Brar, Dr. Liu and Ms. Moe are employees of Medtronic.
Dr. Saito, Dr. Spriggs and Dr. McLaurin—nothing to disclose
- Received April 10, 2017.
- Revision received May 1, 2017.
- Accepted May 4, 2017.