Author + information
- Received February 23, 2011
- Revision received March 9, 2011
- Accepted March 10, 2011
- Published online April 26, 2011.
- Alan C. Yeung, MD⁎,
- Martin B. Leon, MD‡,
- Ash Jain, MD†,
- Thaddeus R. Tolleson, MD§,
- Douglas J. Spriggs, MD∥,
- Brent T. Mc Laurin, MD¶,
- Jeffrey J. Popma, MD#,
- Peter J. Fitzgerald, MD⁎,
- Donald E. Cutlip, MD⁎⁎,
- Joseph M. Massaro, PhD††,
- Laura Mauri, MD, MSc‡‡,⁎ (, )
- RESOLUTE US Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Laura Mauri, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, Massachusetts 02115
Objectives The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population.
Background The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety.
Methods The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores.
Results Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = −2.8%, upper 1-sided 95% confidence interval: −1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%.
Conclusions The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453)
The RESOLUTE US Trial is funded by Medtronic, Inc., Santa Rosa, California. The Data Coordinating Center is Harvard Clinical Research Institute. Drs. Yeung and Leon are on a scientific advisory board for Medtronic. Dr. Jain has received lecture honoraria from Medtronic. Dr. Popma receives institutional research grants from Medtronic, Abbott, Boston Scientific, and Cordis; and he serves on the Advisory Boards of Boston Scientific, Cordis, and Abbott. Dr. Fitzgerald is a consultant and on a scientific advisory board for Medtronic. Dr. Cutlip is a Principal Investigator for Medtronic (paid to institution). Dr. Massaro is a paid consultant for Harvard Clinical Research Institute (HCRI) and, through his relationship with HCRI, received salary for statistical analysis and payment from Medtronic. Dr. Mauri receives institutional research support from Cordis, Medtronic, Abbott Vascular, Boston Scientific, Eli Lilly, Daiichi Sankyo, Bristol-Myers Squibb, and sanofi-aventis and is a consultant to Medtronic and Cordis. All other authors have reported that they have no relationships to disclose.
- Received February 23, 2011.
- Revision received March 9, 2011.
- Accepted March 10, 2011.
- American College of Cardiology Foundation